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.

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.”