[Federal Register Volume 61, Number 170 (Friday, August 30, 1996)]
[Notices]
[Page 45978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 90N-0172]


Medical Devices; Development of Design Control Inspectional 
Strategies; Notice of Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting intended to explore and develop strategies to be utilized by 
FDA's investigators when inspecting a medical device facility relative 
to design controls, after issuing the final quality system regulation. 
The purpose of the meeting is to obtain information from the medical 
device industry and other members of the public about their perspective 
and practical experience in exercising design controls. This meeting is 
intended to provide an opportunity to work with FDA towards 
constructing an investigational model for design controls which will 
become the basis for future establishment inspections.

DATES: The public meeting will be held on September 12, 1996, from 8:30 
a.m. to 4:30 p.m. There is no cost to attend, however, due to space 
limitations, registration is required and must be submitted by 
September 4, 1996.

ADDRESSES: The public meeting will be held at the Parklawn Bldg., 5600 
Fishers Lane, conference room M, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kimberly A. Trautman, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-341), Food 
and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-
594-4648, ext. 126, FAX number 301-594-4672. Persons interested in 
attending this meeting should FAX a request for participation no later 
than the close of business on Wednesday, September 4, 1996. Please 
include name, firm affiliation if any, job title, address, telephone 
number, and FAX number to the contact person. Please do not plan to 
attend this meeting unless you have received a confirmation from the 
Center of Devices and Radiological Health (CDRH) affirming your 
participation. This confirmation will be sent via FAX on a first-come-
first-served basis.

SUPPLEMENTARY INFORMATION: Under notice and comment rulemaking 
procedures initiated in 1990 to implement certain provisions of the 
Safe Medical Devices Act of 1990, FDA plans to issue a final rule 
revising the current good manufacturing practice (CGMP) requirements 
for medical devices and incorporating them into a quality system 
regulation. This action will add preproduction design controls to the 
CGMP regulation and achieve consistency with quality system 
requirements worldwide.
    FDA is interested in obtaining further information regarding 
perspectives and practical experience in exercising design controls. 
Accordingly, FDA's CDRH is conducting a grassroots regulatory 
partnership meeting on September 12, 1996, with interested parties in 
the device industry and members of the public. This meeting is being 
conducted in accordance with President Clinton's reinventing government 
initiatives. The purpose of the meeting will be to address specific 
issues and to explore and develop strategies with regard to how design 
controls will be inspected for compliance with the regulation by FDA's 
investigators at the field District Offices. FDA headquarters and 
District personnel will attend and participate in the meeting.
    Industry, FDA participants, and members of the public will be 
arranged into working teams to review and develop strategies. This is 
an opportunity for the regulated industry and others to work with 
front-line FDA's regulators towards constructing an investigational 
model for design controls which will become the basis for all future 
establishment inspections.
    Upon completion of the grassroots regulatory meeting, FDA will 
formulate its design control inspectional strategy and make this 
strategy document available to the public through the publication of a 
notice of availability in the Federal Register.

    Dated: August 27, 1996.
Joseph A. Levitt,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 96-22284 Filed 8-28-96; 9:56 am]
BILLING CODE 4160-01-F