[Federal Register: March 10, 2004 (Volume 69, Number 47)]
[Rules and Regulations]
[Page 11310-11314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr04-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803, 806, 807, 814, 820, and 1005
Medical Device Reports; Reports of Corrections and Removals;
Establishment Registration and Device Listing: Premarket Approval
Supplements; Quality System Regulation; Importation of Electronic
Products; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is correcting certain
regulations in 21 CFR parts 803, 806, 807, 814, 820, and 1005. This
rule corrects some inadvertent typographical errors and some technical
errors, and it is intended to improve the accuracy of the agency's
regulations.
EFFECTIVE DATE: March 10, 2004.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health, Food and Drug Administration, HFZ-215, Piccard
Dr., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Highlights of Final Rule
FDA is making the following changes in several regulations
concerning medical devices and radiological health to correct errors,
and update addresses and form numbers:
1. FDA is revising 21 CFR 803.18(e) to eliminate a reference to 21
CFR 820.162, a section which no longer exists.
2. FDA is amending Sec. Sec. 806.10(f), 820.198(d), and 820.200(c)
to eliminate references to 21 CFR part 804, a part which no longer
exists.
3. FDA is revising the FDA forms numbers listed in certain sections
of part 807 (21 CFR part 807), specifically Sec. Sec. 807.22, 807.25,
807.26, 807.30, 807.35, and 807.37, to identify the forms correctly.
4. FDA is updating the address in Sec. 807.22 (a).
5. FDA is amending Sec. 807.26 to conform to FDA's existing
procedure. Changes made between annual registration periods are now
done by submitting a letter and need not be submitted on a specific
form.
6. FDA is updating the address in Sec. 807.37 (a) and (b)(2).
7. FDA is amending Sec. 807.30 by removing references to block
numbers for FDA forms. FDA has changed these forms from time to time
and, therefore, the numbers are no longer accurate.
8. FDA is amending Sec. 814.39 by moving part of Sec. 814.39(f)
to Sec. 814.39(e). This paragraph was inadvertently placed in
paragraph (f) after an amendment published on October 8 1998 (63 FR
54043).
9. FDA is amending Sec. 1005.3 by replacing the references to
section 358 of the act with section ``534 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360kk).'' This correction conforms to the
redesignation of this section by the Safe Medical Devices Act of 1990.
II. Environmental Impact
The agency has determined under 21 CFR 25.30(i) that this final
rule is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement was
required. The changes in these amendments do not alter this conclusion.
[[Page 11311]]
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule only corrects errors in existing
regulations and does not change in any way how devices are regulated,
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final rule contains no additional
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VI. The Technical Amendment
This rule corrects certain minor errors in existing regulations.
This administrative action is limited to changing references to form
numbers and block numbers on forms, changing an address to submit
information to FDA, eliminating references to no longer existent
sections and parts, and realigning two paragraphs to correct a
typographical error, but it makes no changes in substantive
requirements.
This document is published as a final rule with the effective date
given previously. Because the final rule is an administrative action,
FDA has determined that it has no substantive impact on the public. It
imposes no costs, and merely makes technical administrative changes in
the Code of Federal Regulations (CFR) for the convenience of the
public. FDA, therefore, for good cause, finds under 5 U.S.C.
553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.
List of Subjects
21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 806
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 820
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 1005
Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
803, 806, 807, 814, 820, and 1005 are amended as follows:
PART 803--MEDICAL DEVICE REPORTING
0
1. The authority section for part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
2. Section 803.18(e) is revised to read as follows:
Sec. 803.18 Files and distributor records.
* * * * *
(e) The manufacturer may maintain MDR event files as part of its
complaint file, under Sec. 820.198 of this chapter, provided that such
records are prominently identified as MDR reportable events. A report
submitted under this subpart A shall not be considered to comply with
this part unless the event has been evaluated in accordance with the
requirements of Sec. 820.198 of this chapter. MDR files shall contain
an explanation of why any information required by this part was not
submitted or could not be obtained. The results of the evaluation of
each event are to be documented and maintained in the manufacturer's
MDR event file.
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
0
3. The authority section for part 806 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
4. Section 806.10(f) is revised to read as follows:
Sec. 806.10 Reports of corrections and removals.
* * * * *
(f) No report of correction or removal is required under this part,
if a report of the correction or removal is required and has been
submitted under parts 803 or 1004 of this chapter.
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
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5. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j,
371, 374.
0
6. Section 807.22 is amended by revising paragraph (b) to read as
follows:
Sec. 807.22 How and where to register establishments and list
devices.
* * * * *
(b) The initial listing of devices and subsequent June and December
updatings shall be on form FDA-2892 (Medical Device Listing). Forms are
obtainable upon request as described in paragraph (a) of this section.
A separate form FDA-2892 shall be submitted for each device or device
class listed with the Food and Drug Administration. Devices having
variations in physical characteristics such as size, package, shape,
color, or composition should be considered to be one device: Provided,
The variation does not change the
[[Page 11312]]
function or intended use of the device. In lieu of form FDA-2892, tapes
for computer input or hard copy computer output may by submitted if
equivalent in all elements of information as specified in form FDA-
2892. All formats proposed for use in lieu of form FDA-2892 require
initial review and approval by the Food and Drug Administration.
* * * * *
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7. Section 807.25 is amended by revising paragraphs (a) and (f)(1),
(f)(2), and (f)(6), and (f)(7) as follows:
Sec. 807.25 Information required or requested for establishment
registration and device listing.
(a) Form FDA-2891 and Form FDA-2891(a) are the approved forms for
initially providing the information required by the act and for
providing annual registration, respectively. The required information
includes the name and street address of the device establishment,
including post office code, all trade names used by the establishment,
and the business trading name of the owner or operator of such
establishment.
* * * * *
(f)* * *
(1) The identification by classification name and number,
proprietary name, and common or usual name of each device being
manufactured, prepared, propagated, compounded, or processed for
commercial distribution that has not been included in any list of
devices previously submitted on form FDA-2892.
(2) The Code of Federal Regulations citation for any applicable
standard for the device under section 514 of the act or section 358 of
the Public Health Service Act.
* * * * *
(6) Other general information requested on form FDA-2892, i.e.,
(i) If the submission refers to a previously listed device, as in
the case of an update, the document number from the initial listing
document for the device,
(ii) The reason for submission,
(iii) The date on which the reason for submission occurred,
(iv) The date that the form FDA-2892 was completed,
(v) The owner's or operator's name and identification number.
(7) Labeling or other descriptive information (e.g., specification
sheets or catalogs) adequate to describe the intended use of a device
when the owner or operator is unable to find an appropriate FDA
classification name for the device.
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8. Section 807.26 is revised to read as follows:
Sec. 807.26 Amendments to establishment registration.
Changes in individual ownership, corporate or partnership
structure, or location of an operation defined in Sec. 807.3(c) shall
be submitted on Form FDA-2891(a) at the time of annual registration, or
by letter if the changes occur at other times. This information shall
be submitted within 30 days of such changes. Changes in the names of
officers and/or directors of the corporation(s) shall be filed with the
establishment's official correspondent and shall be provided to the
Food and Drug Administration upon receipt of a written request for this
information.
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9. Section 807.30 is revised to read as follows:
Sec. 807.30 Updating device listing information.
(a) Form FDA-2892 shall be used to update device listing
information. The preprinted original document number of each form FDA-
2892 on which the device was initially listed shall appear on the form
subsequently used to update the listing information for the device and
on any correspondence related to the device.
(b) An owner or operator shall update the device listing
information during each June and December or, at its discretion, at the
time the change occurs. Conditions that require updating and
information to be submitted for each of these updates are as follows:
(1) If an owner or operator introduces into commercial distribution
a device identified with a classification name not currently listed by
the owner or operator, then the owner or operator must submit form FDA-
2892 containing all the information required by Sec. 807.25(f).
(2) If an owner or operator discontinues commercial distribution of
all devices in the same device class, i.e., with the same
classification name, the owner or operator must submit form FDA-2892
containing the original document number of the form FDA-2892 on which
the device class was initially listed, the reason for submission, the
date of discontinuance, the owner or operator's name and identification
number, the classification name and number, the proprietary name, and
the common or usual name of the discontinued device.
(3) If commercial distribution of a discontinued device identified
on a form FDA-2892 filed under paragraph (b)(2) of this section is
resumed, the owner or operator must submit on form FDA-2892 a notice of
resumption containing: the original document number of the form
initially used to list that device class, the reason for submission,
date of resumption, and all other information required by Sec.
807.25(f).
(4) If one or more classification names for a previously listed
device with multiple classification names has been added or deleted,
the owner or operator must supply the original document number from the
form FDA-2892 on which the device was initially listed and a
supplemental sheet identifying the names of any new or deleted
classification names.
(5) Other changes to information on form FDA-2892 will be updated
as
follows:
(i) Whenever a change occurs only in the owner or operator name or
number, e.g., whenever one company's device line is purchased by
another owner or operator, it will not be necessary to supply a
separate form FDA-2892 for each device. In such cases, the new owner or
operator must follow the procedures in Sec. 807.26 and submit a letter
informing the Food and Drug Administration of the original document
number from form FDA-2892 on which each device was initially listed for
those devices affected by the change in ownership.
(ii) The owner or operator must also submit update information
whenever establishment registration numbers, establishment names, and/
or activities are added to or deleted from form FDA 2892. The owner or
operator must supply the original document number from the form FDA-
2892 on which the device was initially listed, the reason for
submission, and all other information required by Sec. 807.25(f).
(6) Updating is not required if the above information has not
changed since the previously submitted list. Also, updating is not
required if changes occur in proprietary names, in common or usual
names, or to supplemental lists of unclassified components or
accessories.
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10. Section 807.35 is revised to read as follows:
Sec. 807.35 Notification of registrant.
(a) The Commissioner will provide to the official correspondent, at
the address listed on the form, a validated copy of Form FDA-2891 or
Form FDA-2891(a) (whichever is applicable) as evidence of registration.
A permanent registration number will be assigned to each device
establishment registered in accordance with these regulations.
(b) Owners and operators of device establishments who also
manufacture or
[[Page 11313]]
process blood or drug products at the same establishment shall also
register with the Center for Biologics Evaluation and Research and
Center for Drug Evaluation and Research, as appropriate. Blood products
shall be listed with the Center for Biologics Evaluation and Research,
Food and Drug Administration, pursuant to part 607 of this chapter;
drug products shall be listed with the Center for Drug Evaluation and
Research, Food and Drug Administration, pursuant to part 207 of this
chapter.
(c) Although establishment registration and device listing are
required to engage in the device activities described in Sec. 807.20,
validation of registration and the assignment of a device listing
number in itself does not establish that the holder of the registration
is legally qualified to deal in such devices and does not represent a
determination by the Food and Drug Administration as to the status of
any device.
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11. Section 807.37 is revised to read as follows:
Sec. 807.37 Inspection of establishment registration and device
listings.
(a) A copy of the forms FDA-2891 and FDA-2891a filed by the
registrant will be available for inspection in accordance with section
510(f) of the act, at the Center for Devices and Radiological Health
(HFZ-308), Food and Drug Administration, Department of Health and Human
Services, 9200 Corporate Blvd., Rockville, MD 20850-4015. In addition,
there will be available for inspection at each of the Food and Drug
Administration district offices the same information for firms within
the geographical area of such district office. Upon request,
verification of registration number or location of a registered
establishment will be provided.
(b)(1) The following information filed under the device listing
requirements will be available for public disclosure:
(i) Each form FDA-2892 submitted;
(ii) All labels submitted;
(iii) All labeling submitted;
(iv) All advertisements submitted;
(v) All data or information that has already become a matter of
public knowledge.
(2) Requests for device listing information identified in paragraph
(b)(1) of this section should be directed to the Center for Devices and
Radiological Health (HFZ-308), Food and Drug Administration, Department
of Health and Human Services, 9200 Corporate Blvd., Rockville, MD
20850-4015.
(3) Requests for device listing information not identified in
paragraph (b)(1) of this section shall be submitted and handled in
accordance with part 20 of this chapter.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
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12. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
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13. Section 814.39 is amended by revising paragraphs (e) and (f) to
read as follows:
Sec. 814.39 PMA supplements.
* * * * *
(e)(1) FDA will identify a change to a device for which an
applicant has an approved PMA and for which a PMA supplement under
paragraph (a) is not required. FDA will identify such a change in an
advisory opinion under Sec. 10.85, if the change applies to a generic
type of device, or in correspondence to the applicant, if the change
applies only to the applicant's device. FDA will require that a change
for which a PMA supplement under paragraph (a) is not required be
reported to FDA in:
(i) A periodic report under Sec. 814.84 or
(ii) A 30-day PMA supplement under this paragraph.
(2) FDA will identify, in the advisory opinion or correspondence,
the type of information that is to be included in the report or 30-day
PMA supplement. If the change is required to be reported to FDA in a
periodic report, the change may be made before it is reported to FDA.
If the change is required to be reported in a 30-day PMA supplement,
the change may be made 30 days after FDA files the 30-day PMA
supplement unless FDA requires the PMA holder to provide additional
information, informs the PMA holder that the supplement is not
approvable, or disapproves the supplement. The 30-day PMA supplement
shall follow the instructions in the correspondence or advisory
opinion. Any 30-day PMA supplement that does not meet the requirements
of the correspondence or advisory opinion will not be filed and,
therefore, will not be deemed approved 30 days after receipt.
(f) Under section 515(d) of the act, modifications to manufacturing
procedures or methods of manufacture that affect the safety and
effectiveness of a device subject to an approved PMA do not require
submission of a PMA supplement under paragraph (a) of this section and
are eligible to be the subject of a 30-day notice. A 30-day notice
shall describe in detail the change, summarize the data or information
supporting the change, and state that the change has been made in
accordance with the requirements of part 820 of this chapter. The
manufacturer may distribute the device 30 days after the date on which
FDA receives the 30-day notice, unless FDA notifies the applicant
within 30 days from receipt of the notice that the notice is not
adequate. If the notice is not adequate, FDA shall inform the applicant
in writing that a 135-day PMA supplement is needed and shall describe
what further information or action is required for acceptance of such
change. The number of days under review as a 30-day notice shall be
deducted from the 135-day PMA supplement review period if the notice
meets appropriate content requirements for a PMA supplement.
PART 820--QUALITY SYSTEM REGULATION
0
14. The authority citation for 21 CFR part 820 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l 371, 374, 381, 383.
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15. Section 820.198(d) is revised to read as follows
Sec. 820.198 Complaint files.
* * * * *
(d) Any complaint that represents an event which must be reported
to FDA under part 803 of this chapter shall be promptly reviewed,
evaluated, and investigated by a designated individual(s) and shall be
maintained in a separate portion of the complaint files or otherwise
clearly identified. In addition to the information required by Sec.
820.198(e), records of investigation under this paragraph shall include
a determination of:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis;
and
(3) The relationship, if any, of the device to the reported
incident or adverse event.
* * * * *
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16. Section 820.200(c) is revised to read as follows:
Sec. 820.200 Servicing.
* * * * *
(c) Each manufacturer who receives a service report that represents
an event which must be reported to FDA under part 803 of this chapter
shall automatically consider the report a complaint and shall process
it in accordance with the requirements of Sec. 820.198.
* * * * *
[[Page 11314]]
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
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17. The authority citation for 21 CFR part 1005 continues to read as
follows:
Authority: 42 U.S.C. 263d, 263h.
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18. Section 1005.3 is revised to read as follows:
Sec. 1005.3 Importation of noncomplying goods prohibited.
The importation of any electronic product for which standards have
been prescribed under section 534 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360kk) shall be refused admission
into the United States unless there is affixed to such product a
certification in the form of a label or tag in conformity with section
534(h) of the act (21 U.S.C. 360kk(h)). Merchandise refused admission
shall be destroyed or exported under regulations prescribed by the
Secretary of the Treasury unless a timely and adequate petition for
permission to bring the product into compliance is filed and granted
under Sec. Sec. 1005.21 and 1005.22.
Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5302 Filed 3-9-04; 8:45 am]
BILLING CODE 4160-01-S