Sunday, April 21, 2024

Very Brief Blog: FDA Promises Reform, Efficiency in Device Review

 At the Medical Device Manufacturer's Association MDMA, in April 2024, FDA CDRH director Dr Jeff Shuren promised reforms, over time, that will speed up the device review process while reducing the failure rate.  He refers to it as "agile" review.  In software, this refers to rapid sprints to hit new deliverables.

Find an article open access at RAPS:

See also some notes by an observer at Linked In:

Jared Seehafer, at that link, shows a slide about "Statutory Red Tape," the "47 year old framework is not fit for purpose," and solutions to "remove red tape."

Recall February 2024, FDA promised (in a press release) to eventually shift many PMA diagnostics to  Class II / 510(k)