Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Medical Device Manufacturers
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).
David K. Haggard