In a Medtech Insight feature article, life sciences regulatory & compliance partner Joshua Oyster analyzed predetermined change control plans (PCCPs) that have the potential to accelerate U.S. Food and Drug Administration review timelines for medical device modifications.
Joshua notes that while streamlining medical device modifications over a foreseeable timeline with an approved PCCP is an intriguing prospect, he thinks a lot of companies are approaching PCCPs with some caution.
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