FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events
The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.
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Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze
In this case study, experts at the law firm Hogan Lovells and device maker Integrum AB tell Medtech Insight about some hurdles the Swedish start-up jumped when trying to win premarket approval from the US FDA for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019
A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.
Far fewer warning letters are being issued by the US FDA’s device center than in previous years. A center compliance official said that in addition to changes in enforcement practices, the drop was also influenced by CDRH’s recent move to centralize device review staff in the so-called “super-office.”