[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39099-39100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19318]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0437]


New Model Medical Device Development Process; 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 document entitled ``New Model Medical Device 
Development Process.'' In this document, FDA outlines a new model for 
the investigational device exemption (IDE) and premarket approval 
application (PMA) development and review process. FDA is issuing this 
document as part of its commitment to improve the IDE and PMA 
development and review process.

DATES: Written comments concerning this document must be received by 
October 19, 1998.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the document. Written comments concerning this 
document must be submitted to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Comments should be identified with the docket number found in 
brackets in the heading of this document. Submit written requests for 
single copies on a 3.5'' diskette of ``New Model Medical Device 
Development Process'' to the Division of Small Manufacturers 
Assistance, Center for Devices and Radiological Health (HFZ-220), 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.

FOR FURTHER INFORMATION CONTACT: Robert R. Gatling, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1220.
SUPPLEMENTARY INFORMATION:

I. Background

    Despite a marked improvement in device approval times, FDA's Center 
for Devices and Radiological Health (CDRH) is committed to substantial 
improvement of the IDE application and PMA development and review 
process. Often FDA's involvement with the product has been greatest at 
the end of the process--during review of the PMA. The lack of early and 
effective FDA and sponsor interaction too often results in a PMA with 
significant flaws requiring repair, including development of additional 
data, and multiple cycles of PMA review. These cycles can be costly and 
time consuming both for the medical device industry and FDA and can 
delay marketing of new devices.
    As part of its reengineering process, CDRH is proposing a new model 
for the development and review of such class III medical devices that 
includes three tracks: (1) ``Expedited'' review for devices which offer 
significant advantages over current therapy; (2) ``standard'' review 
for most devices; and (3) ``streamlined'' review for devices which are 
very well understood by both the sponsor and FDA.
    The new model also encourages interaction between the agency and 
the applicant, including early agreement on the overall development 
plan, and offers modular submission and review building the application 
and administrative file over time.
    The guidance document outlines why FDA believes that the model will 
lead to ``fast, fair, and smart'' decisions that bring safe and 
effective devices to market as early as possible.
    This guidance document represents the agency's current thinking on 
expediting the IDE/PMA process. 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 
applicable statute, regulations or both. FDA is issuing this as a Level 
1 guidance document. Public comment prior to implementation is not 
required because the guidance is presenting a less burdensome policy 
that is consistent with the public health.

II. Electronic Access

    In order to receive ``New Model Medical Device Development 
Process'' via your fax machine, call the CDRH Facts-On-Demand (FOD) 
system at 1-800-899-0381 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 (1101) followed by 
the pound sign (#). Then follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the guidance may also do 
so 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

[[Page 39100]]

with access to the Web. Updated on a regular basis, the CDRH home page 
includes ``New Medical Device Development Process'' 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.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 1-800-222-0185 
(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, on or before October 19, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this document. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. The document and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 10, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-19318 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F