Summary of the Medical Device User Fee and Modernization Act of 2002
Including Changes Made by the |
The latest version of this document is available on the Internet at -
Text: www.fda.gov/cdrh/mdufma/mdufmasummary.html
PDF: www.fda.gov/cdrh/mdufma/mdufmasummary.pdf
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L 107-250,
amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA
new responsibilities, resources, and challenges. MDUFMA was signed into law
October 26, 2002.
On April 1, 2004, the Medical Devices Technical Corrections Act (MDTCA), P.L.
108-214, was signed into law; MDTCA amends MDUFMA to clarify Congress's
intent and to improve and expand upon some features of MDUFMA. FDA's Internet
site provides the full text of both MDUFMA and MDTCA; we also provide a detailed
summary of the changes made by MDTCA:
MDUFMA (official text) -
Text format: www.fda.gov/cdrh/mdufma/mdufma2002.html
PDF format: www.fda.gov/cdrh/mdufma/mdufma2002.pdfMDTCA (official text) -
Text format: www.fda.gov/cdrh/mdufma/mdtca.html
PDF format: www.fda.gov/cdrh/mdufma/mdtca.pdfSummary of changes made by MDTCA (FDA document) -
Text format: www.fda.gov/cdrh/mdufma/mdtcasummary.html
PDF format: www.fda.gov/cdrh/mdufma/mdtcasummary.pdf
Wherever possible, this summary provides citations to sections of the Food, Drug, and Cosmetic Act (referred to as the "FD&C Act"), as amended by MDUFMA and MDTCA. Except where otherwise stated --
FDA MDUFMA Guidance. In some instances, FDA has developed guidance that explains how we are interpreting and applying a particular MDUFMA provision or program. This summary includes references to FDA guidance only when the guidance is essential to a basic understanding of a statutory provision or when the guidance fulfills a statutory requirement. FDA provides a complete list of all MDUFMA guidance documents on our Internet site, with links to the documents in text and PDF formats; see www.fda.gov/cdrh/mdufma/guidance.
Key Features of MDUFMA. MDUFMA has four particularly significant features:
The user fees authorized by MDUFMA are intended to add $25.1 million to FDA's medical device budget authority during FY 2003, rising each year until fees amount to $35 million in FY 2007. These sums are protected from inflation and changes in workload and other factors through a set of adjustments. The revenues from these fees, and from additional appropriations, will allow FDA to pursue a set of ambitious performance goals; these goals are summarized in DHHS Secretary Thompson's November 14, 2002 letter to Congress (referred to as the "FDA commitment letter") and are incorporated by reference in MDUFMA; see section 101(3) of MDUFMA (this provision is not codified in the FD&C Act) and sections 738(g)(1)(A)-(D) of the FD&C Act. The payment of a premarket review fee is not linked in any way to FDA's final decision on a submission.
Use of Resources. In enacting MDUFMA, Congress recognized that "the public health will be served" by providing additional funds to FDA for "the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met." The additional resources are to be "dedicated to meeting the goals identified in the letters from the Secretary" to House and Senate committees. See § 101of MDUFMA.
| How Are MDUFMA's Authorized Fee Amounts Adjusted? |
| Section 738(c) of the FD&C Act requires MDUFMA fee revenue targets to be adjusted each year to account for --
|
| Year | Authorized Fee Amounts | Actual Receipts | |
|---|---|---|---|
| FY 2003 Dollars1 | Adjusted2 | ||
| FY 2003 | $25,125,000 | $25,125,000 3 | $21,889,582 |
| FY 2004 | $27,255,000 | $33,896,789 4 | $26,832,000 6 |
| FY 2005 | $29,785,000 | $32,429,908 5 | To be determined |
| FY 2006 | $32,615,000 | To be determined | To be determined |
| FY 2007 | $35,000,000 | To be determined | To be determined |
1 See section 738(b).
2 This is the amount FDA is actually authorized to collect from fees.
See section 738(c).
3 No adjustment, as FY 2003 was the first year of the program.
4 The Adjusted amount for FY 2004 includes a mandatory increase to
account for inflation and a compensating adjustment of $5,478,000. The compensating
adjustment was the projected deficit in FY 2003 user fee receipts at the time
FDA set the fee rates for FY 2004. After the close of FY 2003, FDA determined
that the actual deficit in FY 2003 fee receipts was $3,235,418.
5 The Adjusted amount shown for FY 2005 includes a mandatory increase
to account for inflation No compensating adjustment was included in the Adjusted
amount for FY 2005.
6 Preliminary estimate.
These user fee amounts are in addition to the amounts appropriated by Congress for FDA's medical device program. Total program resources for FY 2003 through FY 2005 are shown in the following table.
| Source | FY 2003 (Actual) |
FY 2004 (Actual) |
FY 2005 (Anticipated) |
|---|---|---|---|
| MDUFMA Review Fees | $21,889,582 | $26,832,000 1 | $32,429,908 2 |
| Appropriations | $193,455,000 | $191,144,000 | $216,699,000 3 |
| Total | $215,346,585 | $217,976,000 1 | $249,130,913 |
1 Preliminary estimate.
2 See FDA's Federal Register notice setting review fees for
FY 2005, 69 F.R. 46153, August
2, 2004.
3 President's Budget Request for FY 2005.
For FY 2005, MDUFMA review fees will provide 13.0% of FDA's total anticipated medical device program resources.
Additional Provisions. Additional provisions added by MDUFMA include:
Purpose. Section 738 of the FD&C Act (added by § 102 of MDUFMA) authorizes FDA to assess fees for the premarket review of --
Applications received on or after October 1, 2002 are subject to a fee. § 106.
Fee revenues will support the "process for the review of device applications," section 737(5), which includes --
Payment of fees. Fees are due when the premarket submission
is made to FDA. In the case of a modular PMA, the entire fee is due with the
first module submitted to FDA. Section 738(a)(1)(C). FDA will not accept a submission
for review until the entire fee due is paid.
Small business fees and waivers. In order to avoid creating
governmental barriers to entry into the device marketplace, the MDUFMA user
fee program contains a provision to protect small businesses. If you qualify
as a small business, you may pay reduced user fees and may obtain a one-time
waiver of the fee for your first premarket application.
Qualification as a small business. To qualify as a small business
under MDUFMA, your gross receipts or sales, including that of all of your affiliates,
partners, and parent firms, cannot exceed $30 million (this is the threshold
for FY 2005; each year, FDA issues new guidance that explains how to qualify
as a small business, including the qualification threshold amount). Sections
738(d)(2)(A)(i) and 738(e)(2)(A). An applicant must pay the standard fee unless
it demonstrates it is a small business by submitting a copy of its most-recent
Federal income tax return (and returns of all affiliates, partners, and parent
firms). Sections 738(d)(2)(B) and 738(e)(2)(B). FDA's decision as to whether
an applicant qualifies as a small business is not reviewable. Sections 738(d)(2)(D)
and 738(e)(2)(D). For additional information on the information you need to
provide to qualify as a small business, see FDA's guidance --
FY 2005 MDUFMA Small Business Qualification Worksheet and Certification --
Text format: www.fda.gov/cdrh/mdufma/guidance/2005.html
PDF format: www.fda.gov/cdrh/mdufma/guidance/2005.pdf
Adjustment of the small business threshold. Each year, FDA can adjust the small business threshold to reflect actual experience; the threshold is to be set to reduce fee revenues 16% below the level that would be received if there were no small business exception. Section 738(d)(2)(A)(ii). For example, if the current threshold ($30 million) results in the loss of too much revenue, FDA may reduce the threshold in the future to a level that will result in a revenue stream that better meets the expectations and intent of Congress.
| Application | Standard Fee Structure1 (Percent of Base Fee) |
Small Business Fee (Percent of Standard Fee) |
|---|---|---|
| Premarket application (PMA, PDP, BLA) | Base Fee2 | 38% |
| Premarket report3 | 100% | 38% |
| Panel-track PMA supplement | 100% | 38% |
| BLA efficacy supplement | 100% | 38% |
| 180-day PMA supplement | 21.5% | 38% |
| Real-time PMA supplement | 7.2% | 38% |
| 510(k) | 1.42% | 80% |
1 Section 738(a)(1)(A).
2 All other fees are a specified percentage of this fee. Section
738(c)(5).
3 A premarket report is essentially a PMA for a class III device
that is a reprocessed single-use device. See section 515(c)(2)(A).
Current Review Fees. FDA announced the MDUFMA review fees for FY 2005 in the Federal Register of August 2, 2004; see 69 F.R. 46153. FY 2005 fees apply to applications received from October 1, 2004 through September 30, 2005. FDA must receive both the application and the entire amount of the fee due for that application by September 30, 2005 or the fee due will be the fee in effect for the next fiscal year, FY 2006 (FDA will announce the fee rates for FY 2006 by August 2, 2005). The following tables show the fees in effect for FY 2005 and fee exemptions and waivers that are available.
| Application | Fees for FY 2005 | |
|---|---|---|
| Standard Fee | Small Business | |
| Premarket application (PMA, PDP, BLA) | $239,237 | $90,910 |
| Premarket report | $239,237 | $90,910 |
| Panel-track PMA supplement | $239,237 | $90,910 |
| BLA efficacy supplement | $239,237 | $90,910 |
| 180-day PMA supplement | $51,436 | $19,546 |
| Real-time PMA supplement | $17,225 | $6,546 |
| 510(k) premarket notification | $3,502 | $2,802 |
| Category | Exemption or Waiver |
|---|---|
| HDE | Exempt from any fee. Section 738(a)(1)(B)(i). |
| BLA for a product licensed for further manufacturing use only | Exempt from any fee. Section 738(a)(1)(B)(ii). |
| First PMA, PDP, BLA, or premarket report from a small business | One-time waiver of the fee that would otherwise apply. Section 738(d)(1). |
| First premarket report submitted by a person who submitted a premarket application for the same device (the reprocessed device) prior to October 1, 2002. | One-time waiver of the fee that would otherwise apply. See section 102(b) of MDUFMA (this waiver is not codified as part of the FD&C Act). This provision is intended to avoid penalizing companies that previously submitted a PMA for a reprocessed device, but who must submit a new application to satisfy the requirements added by MDUFMA. |
| Third-party 510(k) | Exempt from any FDA fee; however, the third-party may charge a fee for its review. Section 738(a)(1)(B)(iv). |
| Any application for a device intended solely for pediatric use. | Exempt from any fee. If an applicant obtains an exemption under this provision, and later submits a supplement for adult use, that supplement is subject to the fee then in effect for an original premarket application. Section 738(a)(1)(B)(v). |
| Any application from a State or Federal Government entity. | Exempt from any fee unless the device is to be distributed commercially. Section 738(a)(1)(B)(iii). |
Failure to pay a fee. If a fee is not paid, the submission
"shall be considered incomplete and shall not be accepted for filing"
until the fee is paid in full. Section 738(f). If a fee is not paid within 30
days after it is due, the fee may be treated as a claim of the U.S. Government.
Section 738(i).
Refunds. Under some conditions, FDA will make a partial refund
of a fee paid for review of a premarket application, premarket report, or supplement.
Upon written request made within 180 days after the fee is due, Section 738(j),
FDA will refund 75% of a fee if we refuse to file a submission, or if the applicant
withdraws a submission prior to our filing decision. Section 738(a)(1)(D)(i)
and (ii). If an applicant withdraws a premarket application, premarket report,
or supplement after filing, but before a first action, FDA may, but
is not required to, refund any portion of the fee, based on the level of effort
already expended; FDA's decision to make or refuse a refund after filing,
and our determination of the amount of any refund, is not reviewable. Section
738(a)(1)(D)(iii). FDA cannot make any refund after we have taken a first action
on a submission (our "first action" can be any of the following
actions: major deficiency, not approvable, approvable, approvable pending GMP
inspection, denial, and approval). Once a 510(k) has been received and the fee
has been paid, FDA cannot make any refund of any portion of the fee. FDA guidance
documents provide additional detail on FDA's implementation of MDUFMA's
refund provisions. See --
The following table summarizes the primary circumstances where FDA may make a partial refund of a MDUFMA user fee and the portion of the fee we will refund.
| Circumstance that Determines the Amount of a Refund |
Type of Submission | |
|---|---|---|
| Premarket Application, Premarket Report, Supplement |
510(k) | |
| Applicant withdraws the submission prior to FDA filing decision |  (FDA will refund 75% of the fee) |
 |
| FDA refuses to file | (FDA will refund 75% of the fee) |
|
| Applicant withdraws after filing, but before an FDA first action | (FDA may, at our discretion, refund a portion of the fee) |
|
| Applicant withdraws after an FDA first action | |
|
= Refund may be available
= No refund will be made
Refund for certain unnecessary 510(k) submissions. FDA will
automatically refund any fee paid for a 510(k) review if we determine that the
product is not a device or if we determine the device is exempt from 510(k)
premarket notification under our classification regulations.
Publication of fees. By August 2 of each year, FDA will announce
new MDUFMA user fees in the Federal Register (60 days before the start of the
upcoming fiscal year).
The new fees go into effect October 1 (the fiscal year runs from October 1
to September 30).
Performance goals. Under section 738(g), FDA is expected to
meet performance goals defined in a letter from DHHS Secretary Thompson to Congress.
This letter, generally referred to as the "FDA commitment letter,"
was published in the Congressional Record (November 19, 2002, page S11549),
and is available on FDA's MDUFMA Internet site.
Few goals apply during FY 2003 and FY 2004, allowing FDA time to hire staff,
build infrastructure, provide guidance to industry, and take other actions to
implement the new law. More goals go into effect each year from FY 2005 through
FY 2007, and the goals become more demanding each year.
In a fiscal year where appropriations for salaries and expenses for devices
and radiological health do not meet certain levels, FDA is "expected to
meet such goals to the extent practicable, taking into account the amounts that
are available . . . for such purpose." Section 738(g)(1)(A)(ii)(I). For
fiscal years 2006 and 2007, if appropriations for that year do not meet certain
levels, FDA may not assess medical device user fees for that year and FDA is
not expected to meet any performance goals for that year. Section 738(g)(1)(C)
and (D).
| Activity | Review Time | Performance Level
(by FY) (-- indicates no quantitative goal) |
|||||
|---|---|---|---|---|---|---|---|
| 2003 | 2004 | 2005 | 2006 | 2007 | |||
| PMAs, Panel-Track Supplements, Premarket Reports | FDA decision (approval, approvable, approvable pending GMP inspection, not approvable, denial) | 320 days | - | - | - | 80% | 90% |
| FDA decision – median performance | 180 days | - | - | - | - | 50% 2 | |
| First action – "major deficiency" letter | 150 days | - | - | 75% | 80% | 90% | |
| First action – all other first actions (approval, approvable, approvable pending GMP inspection, not approvable, or denial) | 180 days | - | - | 75% | 80% | 90% | |
| Second or later action – "major deficiency" letter | 120 days | - | - | 75% | 80% | 90% | |
| Action on an amendment containing a complete response to a "major deficiency" or "not approvable" letter | 180 days | - | - | 75% | 80% | 90% | |
| Action on an amendment containing a complete response to an "approvable" letter | 30 days | 90% | 90% | 90% | 90% | 90% | |
| Expedited PMAs These goals apply when FDA has granted expedited status; the applicant has attended a pre-filing meeting; manufacturing facilities are ready for inspection; and the PMA is substantively complete as defined at the pre-filing meeting. | FDA decision (approval, approvable, approvable pending GMP inspection, not approvable, denial) | 300 days | - | - | 70% | 80% | 90% |
| First action – "major deficiency" letter | 120 days | - | - | 70% | 80% | 90% | |
| First action – all other first actions (approval, approvable, approvable pending GMP inspection, not approvable, or denial) | 170 days | - | - | 70% | 80% | 90% | |
| Second or later action – "major deficiency" letter | 100 days | - | - | 70% | 80% | 90% | |
| Action on an amendment containing a complete response to a "major deficiency" or "not approvable" letter | 170 days | - | - | 70% | 80% | 90% | |
| Action on an amendment containing a complete response to an "approvable" letter | 30 days | 90% | 90% | 90% | 90% | 90% | |
| 180-day PMA Supplements | FDA decision (approval, approvable, approvable pending GMP inspection, not approvable, denial) | 180 days | - | - | 80% | 80% | 90% |
| First action – "not approvable" letter | 120 days | - | - | 80% | 85% | 90% | |
| First action – all other first actions (approval, approvable, approvable pending GMP inspection, not approvable, or denial) | 180 days | - | - | 80% | 85% | 90% | |
| Action on an amendment containing a complete response to a "not approvable" letter | 160 days | - | - | 80% | 85% | 90% | |
| 510(k)s | FDA decision (SE/NSE) | 90 days | - | - | 75% | 75% | 80% 2 |
| First action – "additional information" letter | 75 days | - | - | 70% | 80% | 90% | |
| Second or later action | 60 days | - | - | 70% | 80% | 90% | |
| Biologics Licensing Applications - BLAs | Review and act on standard original BLAs (issue "complete action" letter) | 10.0 months | - | - | - | 75% | 90% |
| Review and act on priority original BLA submissions (issue "complete action" letter) | 6.0 months | - | - | - | 75% | 90% | |
| BLA Supplements | Review and act on standard BLA efficacy supplements (issue "complete action" letter) | 10.0 months | - | - | - | 75% | 90% |
| Review and act on priority BLA efficacy supplements (issue "complete action" letter) | 6.0 months | - | - | - | 75% | 90% | |
| Review and act on BLA manufacturing supplements that require prior approval (issue "complete action" letter) | 4.0 months | - | - | - | 75% | 90% | |
| BLA Resubmissions, BLA Supplement Resubmissions | Review and act on a Class 1 resubmission to an original BLA or BLA efficacy supplement (issue "complete action" letter) | 2.0 months | - | - | 75% | 80% | 90% |
| Review and act on a Class 2 resubmission to an original BLA or BLA efficacy supplement (issue "complete action" letter) | 6.0 months | - | - | 75% | 80% | 90% | |
1 This table summarize all MDUFMA performance goals that have objective review time standards and quantifiable measures of performance. Additional commitments that must be evaluated through descriptive measures are found in section I, paragraphs I through P of FDA's November 14, 2002 commitment letter.
2 This goal will be re-evaluated following the end of fiscal year
2005. FDA will hold a public meeting to consult with its stakeholders and to
determine whether the goal is appropriate for implementation in fiscal year
2007. If FDA determines that the goal is not appropriate, prior to August 1,
2006, the Secretary will send a letter to the Committee on Health, Education,
Labor and pensions of the Senate and to the Energy and Commerce Committee, Subcommittee
on Health of the House of Representatives stating that the goal will not be
implemented and the rationale for its removal. If the goal is removed, the goals
in effect for FY 2006 will remain in effect.
Definitions for the terms used here are provided in Section III of the FDA commitment
letter.
Additional goal commitments. In addition to the detailed quantitative performance goals outlined above, the FDA commitment letter provides several other important goals that do not have specific time frames or direct measures of our performance; these goals are found in Section I, Paragraphs I through P of the FDA commitment letter --
Oversight of MDUFMA Review Fee Provisions. MDUFMA provides for several oversight mechanisms --
Sunset. FDA's authority to collect medical device review fees expires October 1, 2007. § 107.
Background. MDUFMA § 201 and MDTCA § 2(b)(1) amend section 704 of the FD&C Act to authorize FDA-accredited persons to inspect qualified manufacturers of class II and class III devices. An eligible establishment is permitted to select any FDA-accredited person to conduct an inspection in lieu of an FDA inspection, but FDA must approve each selection. See sections 704(g)(1) and 704(g)(6)(B). An inspection by an accredited persons is often referred to as a "third-party inspection."
A third-party inspection may be completed in stages over a two-year period,
section 704(g)(6)(A)(ii). This allows an establishment to schedule a complete
inspection in phases, and to coordinate those phases with other objectives,
such as obtaining ISO certification. It also permits an accredited person to
send specialized personnel at different times to complete an inspection. All
of FDA's inspectional requirements must be met within the two-year period.
Publication of criteria for accreditation and review of requests for
accreditation. As required by section 704(g)(2), FDA has published
a Federal Register notice that provides the criteria we use to accredit
a third-party to conduct inspections of class II and class III device manufacturers.
See 68 F.R. 22400 (April 28, 2003). We have also published a guidance document,
Implementation of the Inspection by Accredited Persons Program Under MDUFMA;
Accreditation Criteria, that explains our accreditation criteria in more
detail. The current guidance (dated October 4, 2004; this edition replaces an
earlier edition dated April 28, 2003) is available at --
Text format: www.fda.gov/cdrh/mdufma/guidance/1200.html
PDF format: www.fda.gov/cdrh/mdufma/guidance/1200.pdf
Within 60 days of receiving a request for accreditation, FDA must inform the requestor "whether the request for accreditation is adequate for review." Section 704(g)(2). No specific timeframe is set for an FDA accreditation decision, but we are to "promptly act on the request." Id.
FDA must publish, on the Internet, a complete list of accredited persons, and the activities for which they are accredited. Section 704(g)(4). FDA provides the current list of accredited persons at www.fda.gov/cdrh/ap-inspection/ap-inspection.html#list.
An establishment that employs an accredited person is responsible for compensation of that person. Section 704(g)(8). FDA does not pay for third-party inspections, and does not set the fees that may be charged by a third-party for an inspection.
Minimum requirements for accreditation. Section 704(g)(3) requires all accredited persons to meet certain criteria. An accredited person --
FDA audits of accredited persons. FDA is to conduct "periodic"
audits to ensure accredited persons "continue to meet the standards of
accreditation." Section 704(g)(5)(A). We may, for example, withdraw our
accreditation (following an opportunity for an informal hearing) if we find
an accredited person is "substantially not in compliance" with our
accreditation criteria, has failed to act "in a manner that is consistent"
with the act, or has a financial conflict of interest with an establishment
it has inspected. Section 704(g)(5)(B). FDA may also temporarily suspend our
accreditation pending an opportunity for an informal hearing. Id.
Not all establishments are eligible for inspection by an accredited
person. To employ an accredited person in lieu of an FDA inspection,
an establishment must meet certain conditions, including:
The intent of these provisions is to focus the use of third-party inspections
on firms that operate in a global market that currently involves multiple inspection
requirements.
The most-recent inspection of the establishment must have been classified by
FDA as "no action indicated" or "voluntary action indicated."
Section 704(g)(6)(A)(i). An establishment where FDA has found more serious problems
will not be eligible for third-party inspections.
The establishment must notify FDA of its proposed selection of an accredited
person. The establishment must notify FDA of the person it intends
to use, and FDA must agree to the selection. Section 704(g)(6)(A)(ii). This
notification must also show that the government of the foreign country in which
the device is to be marketed would recognize an inspection by the accredited
person, or the law of that foreign country would recognize an inspection by
FDA. Id.
FDA determination that an establishment is not eligible for inspection
by an accredited person. If FDA determines the establishment is not
eligible to have a third-party inspection because it does not meet the statutory
requirements, the establishment may, within 30 days of FDA's denial, request
a review of FDA's decision. The review will be conducted by a person designated
by FDA, and will begin within 30 days of the request for review. Section 704(g)(6)(B)(vi).
Restriction on repeated use of accredited persons instead of FDA.
An establishment may not use accredited persons for more than four years (two
complete third-party inspections, each completed within a two-year period) unless
the establishment petitions FDA for a waiver and FDA approves the additional
third-party inspection. Section 704(g)(6)(A)(iv)(I). This provision is intended
to ensure periodic inspection by FDA, while avoiding penalizing companies who
are prepared for an inspection before FDA can conduct it.
There are two paths to "approval" of a petition allowing an establishment
to be inspected by accredited persons for an additional two-year period. One
path requires explicit FDA approval, the other is automatic. The most important
features of each path are --
| FDA may grant the petition if . . . | The petition is "deemed to be granted" if . . . |
|
|
After an establishment has been permitted to use an accredited person for
an additional two years, FDA must conduct the next inspection of the
establishment. Section 704(g)(6)(A)(iv)(I). After FDA has inspected the establishment,
the establishment may again use an accredited person if it meets the normal
requirements that apply to third-party inspections.
FDA action on an establishment's notice that it intends to employ
an accredited person. When an establishment provides notice to FDA
under section 704(g)(6)(A) that it intends to use a third-party to conduct an
inspection, FDA must respond within 30 days. If FDA fails to respond to a notice
within 30 days, the establishment is deemed to have FDA clearance to use the
accredited person it selected. Section 704(g)(6)(B)(i). FDA's response
to a notice may --
When FDA requests additional information, we must provide or deny clearance to use the selected third-party within 60 days of receiving the additional information. If we deny the request, we must state our reasons. If we do not make a decision within 60 days, the establishment is "deemed" to have FDA clearance to use the selected third-party. Sections 704(g)(6)(B)(iv) and (v).
FDA denial of use of an accredited person. If FDA denies
an establishment's selection of an accredited third-party, the establishment
may submit another notice, selecting a different third-party. This notice is
treated in the same manner as an original request. Section 704(g)(6)(B)(v)(II).
FDA oversight. FDA will review all reports of inspection made
by a third-party, and FDA retains the responsibility for making the final compliance
determination following each inspection.
Effect of a finding of "official action indicated" following
an inspection by an accredited person. If an establishment receives
an "official action indicated" following an inspection by an accredited
person, that establishment may use an accredited person for a subsequent inspection
only if --
See section 704(g)(6)(C)(i).
If FDA does not inspect such an establishment within 48 months of its petition to use a third-party, the establishment is eligible for inspection by an accredited person. Section 704(g)(6)(C)(ii).
Report of inspection by an accredited person. An inspection
by an accredited person must be recorded in writing, "in a form and manner
consistent with" FDA inspection reports. Section 704(g)(7)(A). The report
must, among other things, describe each observation, identify matters that may
affect compliance with the FD&C Act, and describe any recommendations made
by the inspector. Section 704(g)(7)(B). A copy of the report is to be provided
to FDA and to the establishment within three weeks of the end of the inspection.
Section 704(g)(7)(C).
If an inspection finds a "condition that could cause or contribute to
an unreasonable risk to the public health," the accredited person must
immediately report the problem to FDA. Section 704(g)(7)(E).
False statements to an accredited person. An employee or agent
of an establishment who makes a false statement to an accredited person is subject
to fine or imprisonment under 18 U.S.C. 1001. Section 704(g)(7)(D).
FDA may continue to inspect any establishment. FDA retains
authority to "inspect any device establishment pursuant to this Act."
Section 704(g)(9).
Suspension of program. For each fiscal year beginning with
FY 2005, if obligations for FDA-conducted inspections of device establishments
fall below certain levels, no third-party inspections may be conducted during
that fiscal year. Section 704(g)(10)(A). This provision is intended to protect
FDA's current resources dedicated to Quality Systems inspections and to
ensure that third-party inspections add to the number of inspections FDA would
otherwise be able to perform. Section 704(g)(10)(B) requires GAO to conduct
a study to determine the baseline appropriation amount to be applied under this
provision. GAO's report, Data to Measure the Timeliness of Reviews
of Medical Device Applications Are Limited (August 2004), is available
at www.fda.gov/cdrh/mdufma/reports/gao-04-1022.pdf.
GAO report and recommendation. GAO is to submit a report on
the third-party inspection program by October 26, 2006 (within four years of
enactment of MDUFMA). The report is to include a recommendation as to whether
the program should be continued or terminated. Section 704(g)(12).
Effect on agreements with foreign governments. The provisions
for inspections by accredited persons have no legal effect on international
agreements (such as the Mutual Recognition Agreement) described in section 803(b)
of the FD&C Act. Section 704(g)(14).
Sunset. The authority for inspections by accredited persons
expires October 1, 2012. Section 704(g)(11).
§ 302 of MDUFMA provides new regulatory requirements for reprocessed
single-use devices.
Definitions. § 302(d) provides definitions for --
Labeling requirements. § 302(a)(1) adds new section 502(v) to the FD&C Act to require reprocessed single-use device to "prominently and conspicuously" bear the statement:
Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device].
Section 502(v) went into effect January 26, 2004 (15 months after enactment);
its requirements apply only to devices "introduced or delivered for introduction
into interstate commerce after such effective date." See § 302(a)(2).
Reconsideration of prior exemptions from 510(k). Section 510(o)(2)(A)
requires FDA to review all critical or semi-critical reprocessed devices that
were exempt from 510(k), and to identity those whose exemption from 510(k) should
be ended. Section 510(o)(2)(C) also requires FDA to publish lists of those devices
in the Federal Register. Termination of an exemption for a reprocessed
device does not affect the 510(k) exemption for the original device.
Section 510(o)(2)(E).
Validation data required for certain existing 510(k)s. Section
510(o)(1)(A) requires FDA to identify the types of reprocessed single-use devices
already subject to 510(k) clearance for which FDA will require "validation
data . . . regarding cleaning and sterilization, and functional performance"
to show that the reprocessed device "will remain substantially equivalent
. . . after the maximum number of times the device is reprocessed as intended"
by the person who submits the 510(k).
Federal Register Notices. On April 30, 2003 and
June 26, 2003, FDA published Federal Register notices identifying the
critical reprocessed single-use devices whose prior exemption from 510(k) is
terminated, and for which validation data is now required in a 510(k). On April
13, 2004, we published a Federal Register notice identifying the semi-critical
reprocessed single-use devices whose prior exemption from 510(k) is terminated,
and for which validation data is now required in a 510(k).
If a 510(k) for a reprocessed device was submitted before FDA publishes the
list required by section 510(o)(1)(A), the 510(k) holder must submit validation
data "not later than nine months after the publication of the list."
Section 510(o)(1)(B). If the device is otherwise in compliance with the act,
marketing may continue during the nine-month grace period, and if a 510(k) is
submitted, marketing may continue until such time as --
All 510(k)s for devices on FDA's list must now include validation data.
If FDA finds the device to be NSE (or it is withdrawn), it may no longer be
marketed. Section 510(o)(1)(B).
Deadline for submission of 510(k)s where an exemption has ended. A 510(k) for a device whose exemption from premarket notification has ended must be submitted to FDA within 15 months of the date FDA published a list that included the device. If the device is otherwise in compliance with the act, marketing may continue during a 15-month grace period, and once a 510(k) is submitted, marketing may continue until such time as --
Section 510(o)(2)(B).
Deadline for submission of validation data where a 510(k) has already been submitted. The 2003 Federal Register notices also included the list of devices, already subject to 510(k) submission requirements, that now require the submission of validation data. If a 510(k) for a reprocessed device was submitted before FDA published this list, the 510(k) holder must submit validation data within nine months of the date of the notice. Section 510(o)(1)(B). If the device is otherwise in compliance with the act, marketing may continue during a nine-month grace period. If a 510(k) has been submitted before the end of the grace period, marketing may continue until --
Section 510(o)(1)(B).
FDA guidance on validation data. FDA has published a guidance document that describes the types of validation data FDA recommends be included in a 510(k) for a reprocessed single-use device. See --
Premarket Report. Section 302(c) creates a new category of premarket submission, the premarket report. A premarket report must be submitted for a class III device that is a reprocessed single-use device that previously required a PMA. See amended § 515(c)(2)(A). Section 515(c)(2)(A) specifies the contents of a premarket report.
Revision of MedWatch forms. § 303 of MDUFMA required FDA to revise our MedWatch problem reporting forms "to facilitate the reporting of information . . . relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused." Revised forms are now available from FDA's MedWatch Internet site, www.fda.gov/medwatch.
MDUFMA § 104(a) authorizes additional appropriations for postmarket surveillance
-- $3 million for FY 2003, $6 million for FY 2004, and "such sums
as may be necessary" in subsequent years. Note: In addition to
this authorization, Congress would have to pass an appropriations act before
FDA would receive any portion of these additional sums.
§ 104(b) requires FDA to conduct, and submit to Congress by January 10,
2007, a study of --
MDUFMA § 202 revoked the sunset date for third-party review of 510(k)s previously found in section 523(c) and replaced it with a new sunset date of October 1, 2007. New § 523(d) requires FDA to study the third-party review program, and to submit a report to Congress by January 10, 2007.
MDUFMA § 203 adds new section 306(m) to the FD&C Act, providing for mandatory debarment of an accredited person who has been convicted of a felony under section 301(gg). The debarment of an individual is permanent, section 306(m)(2)(B), while a corporation or other legal entity shall be debarred for 1 to 10 years, and upon a second conviction, the debarment is permanent. Section 306(m)(2)(A). Under certain circumstances, a debarment may be terminated. Section 306(m)(3).
MDUFMA § 204 establishes an Office, within the Office of the Commissioner, to "ensure the prompt assignment of combination products to agency centers," timely and effective premarket reviews, and effective postmarket regulation. Section 503(g)(4)(A). FDA established the Office of Combination Products to undertake this responsibility; see www.fda.gov/oc/combination for additional information about the office and its activities.
MDUFMA § 205 requires FDA to study "the timeliness and effectiveness
of device premarket reviews" by FDA centers other than CDRH.
The most important requirement is that this report "shall include . .
. specific recommendations on whether responsibility for regulating such devices
should be reassigned" within FDA.
FDA completed this report in August 2003 and submitted it to Congress. FDA's
report is available at www.fda.gov/cber/mdufma/report0803.pdf.
§ 206 of MDUFMA and § 2(b)(2)(B) of MDTCA amend section 502(f) of the FD&C Act to permit device labeling to be provided "solely by electronic means" for --
The electronic labeling must comply with all other requirements of the FD&C
Act; and a manufacturer who uses electronic labeling must "promptly"
provide a paper copy of the labeling upon request, at no additional charge.
The following table summarizes the law as it now stands.
| Setting Where Device is Intended to be Used |
Prescription Devices | In Vitro Diagnostic Devices | ||
|---|---|---|---|---|
| Intended to be Used by a Health Care Professional | All Other Users | Intended to be Used by a Health Care Professional | All Other Users | |
| Health Care Facility | |
|
|
1 |
| Blood Establishment | |
|
|
|
| All Other Settings | |
|
|
|
= Permitted
= Not Permitted
1 If the in vitro diagnostic device is also a prescription device intended to be used in a health care facility, electronic labeling may be used.
MDUMFA § 207 adds new section 510(p) to the FD&C Act, permitting
FDA to require establishment registration "by electronic means"
when feasible. FDA is permitted to grant requests for waivers from electronic
registration.
FDA has not yet proposed to require electronic registration of device establishments.
Under section 513(i)(E), when FDA reviews a 510(k) premarket notification,
our determination of the intended use of the device "shall be based upon
the proposed labeling" provided by the applicant. MDUFMA § 208 revoked
a sunset provision that previously applied to section 513(i)(E). The effect
is to make the requirement permanent.
FDA has published a guidance document explaining our approach to determining
intended use for devices reviewed under the 510(k) premarket notification program;
see --
MDUFMA § 209 amends section 515(c) to create a modular review program
for PMAs. FDA may suspend the program during any fiscal year where our authority
to collect user fees has been suspended (e.g., because appropriations did not
meet required levels). Section 515(c)(3)(A). If FDA determines that a modular
submission is unacceptable, we must provide the applicant a written description
of its deficiencies and identify the information needed to correct those deficiencies.
Section 515(c)(3)(C).
FDA guidance explains how to submit a modular PMA and how FDA will review modular
submissions; see --
Under the FDA commitment letter, FDA will work with stakeholders to develop performance goals for modular reviews. Until specific performance goals are developed, FDA will complete our review of individual modules in as little time as is reasonably possible.
MDUFMA § 211 amends section 510(m)(1) to require FDA to post on the Internet the list of class II devices we have exempted from 510(k), and to update the Internet posting within 30 days of any revision of the list. This list is now available at --
Pediatric expertise on advisory panels. MDUFMA § 210 amends section 515(c) to require, where appropriate, that each medical device advisory panel "includes, or consults with, one or more pediatric experts." FDA has published guidance outlining our procedures to ensure that our advisory panels will appropriately include or consult with pediatric experts; see --
IOM study. MDUFMA § 212 requires FDA to request the Institute
of Medicine "enter into an agreement" to conduct a study of whether
the FD&C Act's provisions for postmarket surveillance provide "adequate
safeguards regarding the use of devices in pediatric populations." See
§§ 212(a) and (b). The Institute is now conducting this study, and
is to report its findings to FDA during 2005.
FDA report. By October 26, 2006 (within four years of enactment), FDA
must submit a report to Congress concerning IOM's findings (see above)
and any recommendations we have "for administrative or legislative changes
to the system of postmarket surveillance" for pediatric devices. §
212(c).
FDA guidance. MDUFMA § 213 required FDA to issue guidance on --
FDA has published a guidance document that discusses the type of safety and effectiveness information needed to support marketing of pediatric devices and measures to be used to help protect pediatric patients (newborns through adolescents up to age 21) during clinical trials of pediatric devices; see --
GAO study. MDUFMA § 214 requires GAO to conduct a study concerning --
Section 214 does not specify the date when GAO must submit its report to Congress.
NIH research. MDUFMA § 215(a) requires NIH to submit to Congress
a report "describing the status of research on breast implants . . . conducted
or supported" by NIH. The NIH report to Congress is available at www4.od.nih.gov/orwh/implants.pdf.
§ 215(b) amends the Public Health Service Act to authorize NIH to conduct or support research on "the long-term health implications of silicone breast implants, both gel and saline filled."
MDUFMA § 301(a) adds new section 502(u) to the FD&C Act, to require
a device to "prominently and conspicuously" bear the name of its
manufacturer. This can be in the form of a "generally recognized"
abbreviation or unique symbol. FDA may waive this requirement for a device if
it is "not feasible" or if it would compromise its safety or effectiveness.
A device that does not bear the name of the manufacturer when required is misbranded.
Section 502(u) goes into effect October 26, 2005 (36 months after enactment
of MDUFMA), and its requirements apply only to devices "introduced . .
. into interstate commerce after such effective date." See § 301(b)
of MDUFMA and § 2(c)(1) of MDTCA.
FDA has determined that effective implementation of section 502(u) is not feasible
until FDA provides guidance to industry to explain how FDA will interpret and
apply the new provision and the circumstances under which a manufacturer may
obtain a waiver of the requirement. Accordingly, we have issued draft guidance
to advise industry that we will exercise enforcement discretion and will not
object if a manufacturer does not make the changes required by section 502(u)
for a period of up to 18 months after FDA issues final guidance on our interpretation
and implementation of this new requirement; see --
Updated November 23, 2004
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