[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Notices]
[Pages 49247-49248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0362]


A New 510(k) Paradigm; Draft of Alternate Approaches to 
Demonstrating Substantial Equivalence in Premarket Notifications; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``A New 510(k) Paradigm--
Alternate Approaches to Demonstrating Substantial Equivalence in 
Premarket Notifications.'' The draft 510(k) paradigm, which is neither 
final nor in effect at this time, presents two alternative methods of 
demonstrating substantial equivalence in premarket notifications, and 
it is intended to conserve FDA's review resources while facilitating 
the introduction of safe and effective devices into interstate 
commerce. The paradigm addresses the type of data needed by the Center 
for Devices and Radiological Health (CDRH) to implement alternative 
procedures in establishing substantial equivalence. The agency requests 
comments on this draft paradigm.

DATES: Submit written comments by November 18, 1997.

ADDRESSES: Submit written requests for single copies of the draft 
paradigm entitled ``A New 510(k) Paradigm--Alternate Approaches to 
Demonstrating Substantial Equivalence in Premarket Notifications'' to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the paradigm. Submit written comments on the 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT: Robert I. Chissler, Program Operations 
Staff (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft paradigm announced in this document presents device 
manufacturers with several optional approaches for obtaining marketing 
clearance for their Class II devices. While the draft paradigm 
maintains the traditional method of demonstrating substantial 
equivalence under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360(k)), it also represents two 
alternatives. The first alternative, the ``Special 510(k): Device 
Modification,''utilizes certain aspects of the quality system 
regulation, while the second alternative, the ``abbreviated 510(k),'' 
relies on the use of special controls and consensus standards to 
facilitate 510(k) review.
    Under section 510(k) of the act, a person who intends to introduce 
a device into commercial distribution is required to submit a premarket 
notification, or 510(k), to FDA at least 90 days before commercial 
distribution is to begin. Section 513(i) of the act (21 U.S.C. 360c(i)) 
stipulates that FDA may issue an order of substantial equivalence, only 
upon making a determination that the device to be introduced into 
commercial distribution is as safe and effective as a legally marketed 
device. Under 21 CFR 807.87, FDA has codified the content requirements 
for premarket notifications to be submitted by device manufacturers in 
support of the substantial equivalence decision. However, FDA has 
discretion in the type of information it deems necessary to meet those 
content requirements.

A. Special 510(k): Device Modification

    The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) 
amended section 520(f) of the act (21 U.S.C. 360j(f)), providing FDA 
with the authority to issue regulations requiring pre-production design 
controls. Under the authority provided by the SMDA, FDA revised its 
current good manufacturing practice requirements to include pre-
production design controls that device manufacturers must follow when 
initially designing devices or when making subsequent modifications to 
those designs.
    Effective June 1, 1997, manufacturers of Class II and certain Class 
I devices must follow design control procedures for their devices 
including device modifications. Product modifications that could 
significantly affect safety and effectiveness are subject to 510(k) 
submission requirements under 21 CFR 807 as well as design control 
requirements under 21 CFR 820.30.
    Because design controls are now in effect and require the conduct 
of verification and validation studies of a type that have 
traditionally been included in 510(k) submissions, FDA believes that 
test results generated under the new design control requirements will 
be sufficient to serve as a basis for certain substantial equivalence 
decisions. In light of the design control requirements, FDA believes 
that it may be appropriate, in certain circumstances, to forgo a 
detailed review of the underlying data normally required in 510(k)'s. 
While FDA would not rely on the design controls procedure requirements 
to issue a determination of substantive equivalence, it would rely on 
the existence of data generated in accordance with those procedures to 
issue a substantial equivalence determination.
    Under the draft 510(k) paradigm, a manufacturer would use the FDA 
guidance document entitled, ``Deciding When to Submit A 510(k) for a 
Change to an Existing Device'' to decide if a device modification could 
be implemented without submission of a new 510(k). If a new 510(k) is 
needed for the modification and if the modification does not affect the 
intended use of the device or the basic fundamental scientific 
technology of the device, conformance with design controls could form 
the basis for clearing the application.
    Special 510(k)'s will be processed by the Office of Device 
Evaluation (ODE) within 30 days of receipt by the

[[Page 49248]]

Document Mail Center (DMC). Modifications which affect the intended use 
or alter the basic fundamental scientific technology of the device are 
not appropriate for review under this type of application, but rather 
they should continue to be subject to routine 510(k) procedures or may 
be subject to an ``Abbreviated 510(k)'' as described in section I.B of 
this document.

B. Abbreviated 510(k)

    The SMDA introduced the concept of special controls as the means by 
which the safety and effectiveness of Class II devices can be ensured. 
Special controls are defined by statute as those controls that provide 
reasonable assurance of the device's safety and effectiveness. 
Recently, considerable effort has been expended to develop the concept 
of a ``special control guidance document'' (SCGD). Under this 
initiative, reasonably foreseeable risks that are associated with a 
type of Class II device would be identified in a SCGD. For each risk, 
the agency would also identify a special control(s) such as a consensus 
standard, labeling content, or postmarket surveillance that would 
address the risk.
    In addition to SCGD's that would be developed for generic Class II 
devices, CDRH is committed to recognizing individual consensus 
standards. The consensus standards could be cited in SCGD's, recognized 
in individual policy statements, or identified as ``special controls'' 
that address specific risks associated with multiple device types. IEC 
60601 is an example of such a consensus standard. It has broad 
applicability to many electromedical devices. FDA's recognition of this 
standard, combined with modified review procedures, could streamline 
the review of many 510(k)'s for devices covered by the standard. 
Finally, by using the accompanying particular standards to adapt the 
general standard to specific devices, the 510(k) review process may be 
further expedited.
    Under the draft paradigm, device manufacturers could choose to 
submit ``Abbreviated 510(k)'s'' for Class II devices when a SCGD exists 
or when FDA has recognized an individual special control such as a 
relevant standard. The incentive for manufacturers to elect to use 
special controls or to declare conformance to recognized standards 
would be a more expedient review of their submissions.

II. Electronic Access

    In order to receive ``A New 510(k) Paradigm--Alternate Approaches 
to Demonstrating Substantial Equivalence in Premarket Notifications'' 
document via your fax machine, call the CDRH Facts-On-Demand (FOD) 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At 
the first voice prompt press 1 to access DSMA Facts, at second voice 
prompt press 2, and then enter the document number (905) followed by 
the pound sign (#). Then follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the paradigm may also do 
so by using the World Wide Web (WWW). CDRH maintains an entry on the 
WWW for easy access to information including text, graphics, and files 
that may be downloaded to a personal computer with access to the Web. 
The CDRH home page, which is updated on a regular basis, includes: The 
draft document entitled ``A New 510(k) Paradigm--Alternate Approaches 
to Demonstrating Substantial Equivalence in Premarket Notifications,'' 
device safety alerts, Federal Register reprints, information on 
premarket submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH home page may be 
accessed at http://www.fda.gov/cdrh. The paradigm will be available at 
http://www.fda.gov/cdrh/ode/parad510.html.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

III. Comments

    Interested persons may, submit to the Dockets Management Branch 
(address above) written comments regarding this paradigm by November 
18, 1997. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments and requests for copies are 
to be identified with the docket number found in brackets in the 
heading of this document. The paradigm and received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 9, 1997.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 97-24955 Filed 9-18-97; 8:45 am]
BILLING CODE 4160-01-F