Accessories to medical devices, what are they and how does FDA regulate them? FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update. FDA defines an accessory to be
What is the guidance about? The guidance addresses general considerations for CGMP requirements for combination products and the purpose and content of specific CGMP provisions addressed in 21 CFR part 4. The guidance also contains hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in part 4 by presenting compliance considerations
Our analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the
The FDA has now approved new regulations pertaining to the registration of Institutional Review Boards. SUMMARY: The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information
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