Clients, please be aware of the final release of the guidance document for reprocessing of medical devices. Earlier this month news came out of a fatal bacterial infection at UCLA Medical Center. The infection was spread by an endoscope, a type of reusable medical device. This sparked discussion around the topic of what role the
Whether you watched the international consumer electronics show this year or not, it’s hard not to notice the plethora of devices used to monitor health and wellbeing. However, are these devices considered products from the perspective of the FDA and thus are subject to regulation? Well, it all comes down to what the product claims
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 FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update.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
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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