[Federal Register Volume 62, Number 200 (Thursday, October 16, 1997)]
[Notices]
[Pages 53786-53787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Medical Devices; Product Development Protocol; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), in cooperation with 
the Health Industry Manufacturers Association (HIMA), is announcing a 
public workshop to discuss use of the Product Development Protocol 
(PDP) as an alternate means for medical device approval. This public 
workshop is being held so that FDA may gather information to assist in 
developing an efficient, practical PDP process.

DATES: The public workshop will be held on Wednesday, October 22, 1997, 
8:30 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Renaissance Hotel, 
999 9th St. NW., Washington, DC 20001. Attendees requiring overnight 
accommodations may contact the hotel at 202-898-9000 and reference the 
FDA/HIMA meeting to ensure conference rates. To register for the public 
workshop, contact HIMA, Meetings Department, 1200 G St. NW., 
Washington, DC 20005, 202-434-7237.

FOR FURTHER INFORMATION CONTACT: Lillian L. Yin, Center for Devices and 
Radiological Health (HFZ-470), 9200

[[Page 53787]]

Corporate Blvd., Rockville, MD 20850, 301- 594-5072, FAX 301-480-4224.

SUPPLEMENTARY INFORMATION: FDA, in cooperation with HIMA, is holding a 
public workshop to discuss the implementation of a different process 
for the premarket approval of class III devices by means of a PDP. 
Section 515(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e (f)) (the act) provides for a product development protocol as an 
alternate means of premarket approval of class III medical devices. 
Although the PDP has existed as a means of approval of a medical device 
since the Medical Device Amendments of 1976 (Pub. L. 94-295) to the 
act, the PDP has never been completely implemented. As part of it's 
reengineering initiative, the Center for Devices and Radiological 
Health (CDRH) of FDA established the PDP Reengineering Team, comprised 
of FDA staff, in consultation with industry representatives, to develop 
an efficient, practical PDP process.
    The intent of the PDP process is to substitute the conventional 
device approval model, the sequential process of clinical investigation 
followed by a premarket approval application, with an early interaction 
between the sponsor and FDA to produce a focused product development 
plan that merges the two steps. A PDP team has developed guidelines for 
creating this focused development protocol that will be described at 
the public workshop. Workshop participants will have ample opportunity 
to ask questions as the new PDP process is described and case studies 
on particular examples of class III devices are presented. Background 
information, a detailed flow chart, and a descriptive narrative 
regarding the proposed PDP process can be found at the FDA/CDRH Web 
site at the address below.
    Additional information is available on the FDA Web page 
(www.fda.gov/cdrh/pdp/pdp.html) or the HIMA Web page (www.himanet.com).

    Dated: September 30, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-27433 Filed 10-15-97; 8:45 am]
BILLING CODE 4160-01-F