[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CDRH Draft Guidance For Industry: Contents of a Product 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availability of a draft guidance entitled ``CDRH Guidance for 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draft guidance is not final nor is it in effect at this time.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diskette of the draft guidance document entitled ``CDRH Guidance for 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]
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