|
[Previous Page]
[Table Of Contents] [Next Page]
ATTACHMENT C - FOI AND DESIGN CONTROLS
Date: June 3, 1997
From: Director, Division of Compliance Policy (HFC-230) Office of Enforcement
Subj: FOI and the New Device CGMP
To: All District Directors
The new medical device Current Good Manufacturing Practice (CGMP) final
rule, also known as the Quality System Regulation, was published in the
Federal Register on October 7, 1996 (61 FR 52602). This regulation, which
became effective on June 1, 1997, includes design control provisions (21
CFR 820.30) for the first time. As a result of these new regulatory requirements,
design control deficiencies and information will be noted on the Design
Control Inspectional Strategy Report (June 1, 1997 through May 31, 1998)
or on the list of Inspectional Observations (FDA 483) after May 31, 1998.
(For additional information, please refer to page number 52604 of the preamble
in the October 7, 1996 Federal Register.) Additionally, the design control
deficiencies and information will also be discussed in the Establishment
Inspection Report.
The design control deviations and information will be related to: (1)
the design or development of new devices that have not yet been commercially
distributed; (2) devices that are in commercial distribution and are undergoing
a design change; or (3) commercially marketed devices which were in the
design or development process on or after June 1, 1997, but which have
not yet undergone a design change.
Some information related to design controls might be the type of information
that is considered either: (1) a trade secret, or (2) commercial or financial
information that is privileged or confidential as defined in 21 CFR 20.61.
If it is, that particular design control information is exempt from public
disclosure under the Freedom of Information (FOI) Act. For new devices
that have not been distributed, some examples of design control information
that should be purged from the documents because it is not publicly known,
pursuant to 21 CFR 20.61, are brand and generic names, actual or proposed
design, labeling, and specifications.
In view of the above discussion, all field employees who release Agency
documents under FOI should be especially careful and diligent in deleting
all non-disclosable information. Please forward a copy of this memorandum
to all FOI personnel within your district.
If you have any questions, please contact Jeffrey Governale of my staff
via electronic mail, facsimile (301-827-0482) or telephone (301-827-0411).
/s/
David K. Haggard
|
