R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:

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