Similar to the MAPP discussed in a previous post, the Compliance Program Guidance Manual (CPGM) contains the instructions used by FDA personnel to perform the agency’s compliance work. Unlike the MAPP, the instructions in the CPGM are more like FDA guidance in that they create no rights or obligations and another approach may be used if it meets the legal and regulatory requirements. Those working with the FDA are well advised to be familiar with the CPGM related to their work, as they provide valuable clues on what to expect. Some CPGM that caught my eye include
- 7342.008 – Inspection of Licensed In Vitro Diagnostic Devices,
- 7346.832 – Pre-Approval Inspections/Investigations,
- 7356.002A – Sterile Drug Process Inspections, and
- 7383.001 – Medical Device Premarket Approval and Postmarket Inspections.
The CPGM page for CDRH also has the links to its Case for Quality programs, something we’ll discuss in another post.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers