[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Pages 40128-40129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19899]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0563]
CDRH Draft Guidance For Industry: Contents of a Product
Development Protocol; 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availability of a draft guidance entitled ``CDRH Guidance for
Industry--Contents of a Product Development Protocol; Draft''. This
draft guidance is not final nor is it in effect at this time. This
document provides guidance on the content of product development
protocol (PDP) applications, expected actions and timeframes in the
development of a product under a PDP, and how changes during the course
of product development under a PDP should be handled.
DATES: Written comments must be received by October 26, 1998.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``CDRH Guidance for
Industry--Contents of a Product Development Protocol; Draft'' 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. Written comments concerning this document must
be submitted to the Dockets Management Branch (HFA-
[[Page 40129]]
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the document
number found in brackets in the heading of this document. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
FOR FURTHER INFORMATION CONTACT:
For general information on the PDP process, or to comment on this
guidance, please contact: Kathy M. Poneleit, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20857, 301-594-2186.
For information concerning the design control and GMP aspects of
this guidance, please contact: Sandy Weininger, Center for Devices and
Radiological Health (HFZ-141), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20857, 301-443-2536, ext. 34.
SUPPLEMENTARY INFORMATION:
I. Background
Section 515(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(f)) provides an alternative to the investigational device
exemption (IDE) and PMA processes for class III devices subject to
premarket approval. This alternative process, PDP, was not implemented
during the early years of FDA's medical device program because it was
considered potentially complex and there was a need to focus attention
on implementing the core provisions of the Medical Device Amendments of
1976, such as the IDE, premarket approval, 510(k), good manufacturing
practices, and problem reporting requirements.
This document provides guidance on the content of PDP applications,
expected actions and timeframes in the development of a product under a
PDP, and how changes during the course of product development under a
PDP should be handled. This draft guidance also provides a framework
for interaction between FDA and the applicant; but, because of the wide
range of devices that may be developed under the PDP authority, it is
unlikely that every element addressed in the guidance will apply to any
given device.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on the PDP process and the relative duties and
responsibilities of the agency and the applicant. 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.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
``CDRH Guidance for Industry--Contents of a Product Development
Protocol; Draft'' is available by fax from CDRH's 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 the second
voice prompt, press 2, and then enter the document number 473 followed
by the pound sign (#). Then follow the remaining voice prompts to
complete your request.
Persons interested in obtaining a copy of the draft 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 with access to the
WWW. Updated on a regular basis, the CDRH Home Page includes ``Guidance
for Industry--Contents of a Product Development Protocol; Draft''
device safety alerts, Federal Register reprints, information on
premarket submissions (including lists of approved applications and
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 ``Guidance for Industry--Contents of a Product
Development Protocol; Draft'' will be available at ``http://
www.fda.gov/cdrh/pdp/.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.
IV. Comments
Interested persons may, on or before October 26, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. 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 guidance 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 9, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-19899 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F
