Ready, Set, GO! From Device Recalls To FDA Inspectional Changes, QA/RA Experts Must Leap Hurdles In 2018
Executive Summary
Device-makers could be in for a change to how they handle product recalls now that US FDA is reevaluating its processes for market withdrawals. That's according to longtime device industry expert Steve Niedelman, who also points out other hot topics that quality and regulatory professionals need to keep a sharp eye on this year – such as the device center's "Total Product Life Cycle" approach and next moves in its "program alignment" inspection scheme – in this Medtech Insight podcast.
How device-makers conduct product recalls is coming under scrutiny from US FDA – and that's just one of several top quality and regulatory hotspots that QA/RA professionals should keep tabs on in the new year.
That's according to longtime device industry expert Steve Niedelman, who says the agency's Center for Devices and Radiological Health is reevaluating its recalls program – a move that could lead the center to "create perhaps a recall program that is distinct from the rest of the agency."
Niedelman, lead quality systems and compliance consultant at law firm King & Spalding, made his comments in a podcast for Medtech Insight that highlights quality and regulatory hotspots upcoming in 2018. Niedelman is a familiar face in the medical device arena; he worked at FDA for 34 years in CDRH and the Office of Regulatory Affairs.
Niedelman says CDRH is looking to "create a recall program whereby what may currently be considered a recall or classified as such by FDA may no longer [be]." He adds that the device center also wants to "take a fresh look at what resources and what steps the agency has been taking to classify recalls, and initiatives that the industry can undertake as well to reduce the number of recalls for the medical device program."
In the podcast – which is below – Niedelman says the center will likely release information sometime this spring about its work on reevaluating the device recalls program.
"So, there's a lot going on," he says. "These are just some of the bigger-ticket items that I think are important for this coming year that the industry needs to keep their eyes on":
- 1:00 mark: FDA's "program alignment" inspection scheme;
- 2:14 mark: CDRH's "Total Product Life Cycle" approach;
- 4:32 mark: Case for Quality pilot programs – the "PMA Critical to Quality Pilot" and the "Voluntary Medical Device and Product Quality Pilot";
- 6:22 mark: The Medical Device Single Audit Program;
- 7:54 mark: FDA and industry work on benefit/risk activities; and
- 10:25 mark: FDA review of the recalls process.
From the editors of The Gray Sheet