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Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance
for Industry and CDRH StaffThis document is intended to provide guidance. It represents
the Agency's current thinking on the above. It does not create
or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable
statute, regulations, or both.
Until May 26, 1998, comments and suggestions regarding this document should be submitted to Docket No. 98D-0082. Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 12420 Parklawn Drive (HFA-305), Room 1-23, Rockville, MD 20857. Such comments will be considered when determining whether to amend the current guidance.
After May 26, 1998, comments and suggestions may be submitted at any time for Agency
consideration to
Heather Rosecrans, 9200 Corporate Blvd., HFZ-404, Rockville, MD 20850.
Comments may not be acted upon by the Agency until the document
is next revised or updated. For questions regarding the use or
interpretation of this guidance contact Heather Rosecrans at 240-276-4021.
Additional Copies:World Wide Web/CDRH home page :http://www.fda.gov/cdrh
or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify
number 199 when prompted for the document shelf number.
Purpose
The purpose of this memorandum is to provide guidance to Center
for Devices and Radiological Health (CDRH) personnel and to manufacturers
on the process and procedures to be followed by Office of Device
Evaluation (ODE) review staff in implementing new Section 513
(f) (2) of the Federal Food, Drug, and Cosmetic Act (the Act)1.
This provision, which is referred to as the Evaluation of Automatic
Class III Designation provision (also known as "de novo"
or "risk-based" classification), was added by Section
207 of the FDA Modernization Act of 1997 (FDAMA). It is intended
to apply to low risk products that have been classified as class
III because they were found not substantially equivalent (NSE)
to any identifiable predicate device.
Background
On November 21, 1997, The Food and Drug Administration Modernization
Act of 1997 amended Section 513(f) (21 U.S.C. 360c(f)) to provide
a new mechanism to reclassify statutorily classified class III
products.
The legislative history of this provision contemplates a process
that permits the Secretary (FDA, by delegation) to reclassify
certain low risk devices into class I or II on the basis of established
risk-based classification criteria when a new device is classified
into class III under the statute because there is no predicate
device to which it can be found substantially equivalent. Congress
included this section to limit unnecessary expenditure of CDRH
and manufacturer resources that could occur if low risk devices
were subject to premarket approval (PMA) under section 515. The
section was not intended to significantly increase the number
of not substantially equivalent determinations or to otherwise
alter the 510(k) provisions of the Act or CDRH's approach to the
510(k) classification process. Under the new provision, within
thirty (30) days after receiving a not substantially equivalent
determination (which is a classification order reflecting placement
of the device into class III by operation of the statute), the
person receiving the classification order may request that a risk-based
classification determination be made for the device. The request
must provide a description of the device and detailed information
and reasons for any recommended classification. FDA will then
classify the device based on section 513(a)(1) of the Act, which
sets forth the criteria used to classify and reclassify devices.
Not later than sixty (60) days after the date of the submission
of such a request, FDA must make a classification determination
by written order, placing the device into one of the three statutory
device classes. A device placed into class I or II in this written
order can then be commercially distributed, subject to other applicable
provisions of the Act. A device classified into class III may
not be marketed based on the classification order and will require
an approved premarket application or completed product development
protocol (PDP) under section 515 before commercial distribution
can commence. Any clinical studies performed with a class III
device must be performed in accordance with the investigational
device exemption (IDE) provision of the Act (section 520(g)) and
implementing regulations (21 CFR 812). A device classified
into class I or II under this new provision becomes a predicate
device for future premarket notification submissions, which means
that any manufacturer may show that a new device is substantially
equivalent to this predicate.
Class I is to include devices where general controls by themselves
are sufficient to provide reasonable assurance of its safety and
effectiveness. Class II is applicable if there is sufficient
information to establish special controls which, together with
general controls, provide reasonable assurance of safety and
effectiveness. Within 30 days after the issuance of an order
classifying a device into class I or II under this section, FDA
will publish a notice in the Federal Register announcing the classification
and the controls necessary to provide reasonable assurance of
safety and effectiveness.
This guidance is intended for reference by CDRH staff and manufacturers
to outline the process and timelines for reviewing submissions
under this Evaluation of Automatic Class III Designation section.
Manufacturers are encouraged to contact the Premarket Notification
Section, Program Operations Staff, ODE, CDRH at (301) 594-1190
if additional or specific guidance on a particular device is necessary.
The Evaluation of Automatic Class III Designation Process
Under new 513(f)(2), devices that have been found not substantially
equivalent due to lack of a predicate may be placed in class I
if the general controls described in the Act are sufficient to
provide reasonable assurance of safety and effectiveness. If
general controls are not adequate, a device will be placed in
class II if there is sufficient information to establish special
controls which, together with the general controls, provide such
assurance. Special controls may include performance standards,
postmarket surveillance, patient registries, and development and
dissemination of guidelines (including guidelines for the submission
of clinical data in premarket notification submissions in accordance
with section 510(k)). Devices placed into class II are subject
to these controls. The Agency will need to reach a conclusion
that the reasonable assurance of safety and effectiveness standard
is met by the information in the 510(k) and the accompanying request
for Evaluation of Automatic Class III Designation as a basis for
placing the product in either class I or II. A product will be
classified as class III if general controls are not adequate to
provide reasonable assurance of safety and effectiveness and there
is not sufficient information to establish special controls that
would provide such assurance. Attachment 1 outlines the process
FDA intends to follow for Evaluation of Automatic Class III Designations
under 513(f)(2). While the process is new, its implementation
is based on using the types of information and data ordinarily
submitted in 510(k)s and/or reclassification petitions.
A. When Evaluation of Automatic Class III Designation May
Be Used
The statute limits consideration to those devices that have not
been previously classified under the Act, and that have been classified
into class III by written notice. The legislative history instructs
the Agency to limit consideration to lower risk devices that have
been found not substantially equivalent because no predicate device
exists. If, during review of a 510(k) submission for such a device,
the Agency identifies other issues needing resolution before the
Agency can completely review a request for Evaluation of Automatic
Class III Designation, those issues should be addressed in the
510(k) review.
A request for classification under 513(f)(2) may be considered
only if it is submitted within 30 days following the manufacturer's
receipt of an NSE determination. If a manufacturer has not previously
submitted a premarket notification (510(k)) or if the NSE order
was not received within the previous thirty (30) days, the manufacturer
should submit a new 510(k) for the device. Submitting a new 510(k)
may also be appropriate if the NSE determination indicates that
additional information is likely to be required to establish that
general or special controls will permit classification of the
device into class I or II under the 513(f)(2) classification process.
Because this new provision of the Act becomes effective February
20, 1998, any manufacturer that has received an NSE determination
on or after January 21, 1998, may consider filing a request under
513(f)(2). As an alternative to using the 513(f)(2) classification
procedure, a manufacturer may choose to file a reclassification
petition in accordance with 21 CFR 860.134. This petition process
requires neither prior submission of a 510(k), nor subsequent
receipt of an NSE determination. Nor is it limited to requests
submitted within 30 days following receipt of such an NSE determination.
B. The Request For Evaluation of Automatic Class III Designation
Under the new section 513(f)(2), submitters of a request for Evaluation
of Automatic Class III Designation must describe the device and
provide detailed information and, if they elect to recommend a
classification, reasons for the classification they recommend.
In order to facilitate the classification process, submitters
are requested to provide the types of information ordinarily contained
in 510(k)s and/or reclassification petitions (please refer to
Attachment 2, which describes the Agency's preference on the contents
of a request for Evaluation of Automatic Class III Designation).
Submitters are requested to identify the risks and benefits of
the device, the general and special controls they believe applicable
to the device, and the submitter's recommendation for placement
into class I or class II. For devices recommended to be placed
in class I, submitters are specifically requested to recommend
whether they believe a device should be exempt from the 510(k)
requirements and the design controls provisions of the Quality
Systems Regulation (QSR). If the submitter believes general controls
by themselves are insufficient to provide reasonable assurance
of the safety and effectiveness of the device, the submitter is
requested to identify the special controls necessary to provide
such assurance, which would provide the Agency with a basis to
place the device in class II. Information to support such recommendations
should be included in the request. This information will be combined
with the previously submitted information contained in the 510(k)
premarket notification and considered in FDA's review of the request
for Evaluation of Automatic Class III Designation.
Any available data from human experience with the device also
should be provided. Human clinical experience will be especially
useful to the Agency in determining if and which general and special
controls will be necessary to provide reasonable assurance of
safety and effectiveness. However, where human clinical data
are not available, the submitter may offer arguments based on
bench and animal testing results as well as deductive reasoning
as to why FDA should classify the product into class I or class
II.
If a device is classified into class I or II in response to a
request under 513(f)(2), the device may be legally marketed, subject
to the Act's other requirements, and becomes a predicate device
for subsequent 510(k) submissions.
Procedures for Review by CDRH
In order to be placed in class I or II under the Evaluation of
Automatic Class III Designation provision, a device must first
have been reviewed in connection with a 510(k) premarket notification.
It is important that this review consider all aspects of the
device. If the division identifies questions of safety and effectiveness
that suggest additional information is needed, these issues should
either be addressed through deficiency letters and responses,
or the NSE letter should indicate that these issues have not been
resolved. This will afford applicants the opportunity to submit
a revised 510(k) addressing these concerns before making a request
under 513(f)(2). If a device is found not substantially equivalent
because a predicate device cannot be identified and the device
appears to be a low risk device, the NSE letter to the applicant
should indicate that the product may be appropriate for Evaluation
of Automatic Class III Designation under 513(f)(2). If it is
apparent to FDA staff that appropriate classification under 513(f)(2)
may require input from an advisory panel during the sixty (60)
day time frame allotted for review of a request, staff should
begin arrangements for convening such a panel as early as possible.
If, while reviewing the 510(k), the division determines that
the device is not a likely candidate for Evaluation of Automatic
Class III Designation, the NSE letter should indicate that FDA
believes premarket approval will be necessary prior to marketing
the device.
Upon receiving a request under 513(f)(2), the FDA will conduct an initial administrative review to confirm that the request contains the necessary information (see Attachment 2). If FDA finds that the request does not have sufficient information for review, the Agency intends to notify the applicant by telephone that the request is incomplete and identify the information needed to permit a substantive review. If the additional information necessary to review the request is not received within thirty (30) days, FDA will maintain the device in class III. Substantive review of a request and final classification will be processed within sixty (60) days of receipt of complete and timely requests by the Document Mail Center. Final action will be by written order classifying the device into either class I, II, or III. Requests for Evaluation of Automatic Class III Designation should be submitted to:
Document Mail Center, ODE, (HFZ-401)
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850
Once a request for Evaluation of Automatic Class III Designation
has been submitted, reviewers should apply the criteria set forth
in section 513 of the Act. If general and/or special controls
are insufficient to provide a reasonable assurance of safety and
effectiveness, the device will remain in class III and require
premarket approval under section 515 prior to marketing. If special
controls are identified which provide the basis for placement
into class II, they must be specified and must identify the underlying
issue(s) of safety or effectiveness addressed so that they can
be applied to other products of a similar type.
The review should be based on the information submitted in the
request for Evaluation of Automatic Class III Designation as well
as information submitted in the 510(k). The division reviewing
the request will be responsible for drafting the written order
determining the classification of the device as well as a draft
federal register notice announcing the classification of a device
into class I or class II. These orders should be in the form
of a classification action and identify the applicability of design
controls and 510(k) notification for class I products and identify
the special controls for class II products. Both the order and
the notice should be signed by the Director, Office of Device
Evaluation (ODE).
Within thirty (30) days of receipt of the request by the Document
Mail Center (DMC), the division reviewing the request should coordinate
an issues resolution meeting with the Office Director. Following
the issues resolution meeting, the reviewing division should draft
the written order as well as the draft federal register notice
announcing the classification, using the boilerplates developed
for Evaluation of Automatic Class III Designation. These drafts
should be completed by day forty-five (45) following receipt of
the request. A signed order classifying the device should be
sent to the requester by day sixty (60) following receipt of the
request. The written order classifying the device shall be the
initial classification of the device and any device classified
into class I or class II in response to the request for classification
under 513(f)(2) will serve as a predicate device for future determinations
of substantial equivalence. The Program Operations Staff in ODE
will track the Federal register notice announcing class I or class
II classifications and ensure the notice will be published within
thirty (30) days after the written classification order has been
signed.
Conclusion
The Center for Devices and Radiological Health believes that the Evaluation of Automatic Class III Designation process can be useful for certain low risk devices that have no predicate. Public input prior to implementation of this guidance was not practicable because the provision allowing classification under 513(f)(2) becomes effective February 20, 1998. However, comments are welcome and should be addressed to Jim Dillard, Deputy Director DGRD, Center for Devices and Radiological Health, Office of Device Evaluation, 9200 Corporate Boulevard, Rockville, Maryland 20850. The Agency will review all comments and make changes, as appropriate. Interested parties should recognize that procedures and processes may change as the Agency and industry develop experience using this new provision. Changes will be publicized and implemented in accordance with FDA's good guidance practices.
In order to facilitate review, the request for Evaluation of Automatic Class III Designation should include the following information:
Guidance Pertaining to the FDA Modernization Act
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