As part of its “approval process at 35 years” reflection undertaken last year, US regulatory authority the FDA pledged to revisit its postmarketing surveillance demands, in no small part due to what it calls “several high-profile medical device performance concerns.”
Now the revisitation is complete and the agency has issued new proposals in a document entitled Strengthening our National System for Medical Device Postmarketing Surveillance, which can be found here.
And it’s a good and sensible, if not unpredictable, read. The four basic tenets of the proposals have been fairly widely advertised and include the introduction of unique device identification, promotion and development of device registries, modernisation of adverse event reporting (and analysis) and increased focus on evidence generation, synthesis and appraisal.
It’s difficult to argue with the need for all four improvements, although the magic will be in the implementation rather than the headline. We’ll pore over the report some more and see what it might also mean for the EU as it faces up to the same fundamental issues. The key, in our view, will be section four on evidence, which at first glance sounds like the most nebulous element.
The FDA is putting this out there for comment and will be holding a series of meetings of stakeholders during the course of this month.