Recall Effectiveness Checks: FDA Tips

Conducting device recall effectiveness checks can be tricky. Two FDA officials offer advice to make the process work smoother and explain why Unique Device Identification will be helpful in this month’s “Compliance Corner.”

The lynchpin of a good product recall effectiveness check is ensuring adequate documentation, an FDA recall coordinator says.

Effectiveness checks happen when companies contact product users to make sure they know that a recall is underway. They also...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

More from Policy & Regulation

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By 

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By 

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.