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New guidance to advance medical device safety, regulatory oversight, and innovation 

On April 17, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) issued its . As an update to their , the safety reports is aligned with CDRH's vision to protect public health and ensure access to safe and effective medical devices by keeping up with the growth in technology and types of medical devices. 

According to CDRH, the actions detailed in the safety report, alongside those in the recently issued , will help protect patients by quickly addressing impacts to safety while fostering innovation for the more than 257,000 different types of medical devices on the U.S. market made by around 22,000 device manufacturing firms around the world. 

Key takeaways from the safety report include:

Prioritization of manufacturing quality 

• Streamlining the  (MDSAP), which allows a single regulatory audit of a medical device manufacturer 
• Increasing manufacturer enrollment in the (VIP), which uses a combination of a globally accepted maturity model and FDA regulatory opportunities to accelerate device quality and manufacturing improvements
• Supporting development of tools to better detect device quality issues

Postmarket surveillance 

• Using (RWD) through the hospital and clinic network to inform medical device development and evaluation throughout the total product lifecycle
• Incorporating  (UDIs) in medical device reports (MDRs) to better track specific products

Recalls 

• Guidance to differentiate between  
• Supporting
• Enhancing Medical Device Reporting (MDR) tracking and the  (MAUDE) database, which contains adverse medical device reports

Advanced device cybersecurity

• Launching  and 
• Ensuring timely responses to incidents

Impact on stakeholders

The actions and work detailed in the safety report highlight how manufacturers participating in the VIP are showing a year-over-year downward trend in recalls. Manufacturers who incorporate various data sources (e.g., RWD, UDI) may also be able to enhance tracking of product specific performance throughout the total product lifecycle. CDRH has also provided additional guidance to further help firms determine product removals and initiation of voluntary recalls.