[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
