FDA releases new medical device safety action plan

The FDA released, "Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health," in an effort to enhance programs and processes to assure the safety of medical devices.  

"Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs," according to an FDA press release published April 17.  

The new action plan highlights five key components:   

  • Establish a robust medical device patient safety net in the U.S.

  • Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations.

  • Spur innovation towards safer medical devices.

  • Advance medical device cybersecurity.

  • Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety. 

In addition to the following, the FDA also plans to improve the quality and efficiency of "real-world evidence generation" of medical technology devices used in women's health, according to action plan. 

This effort will complement the National Evaluation System for health Technology, or NEST, an active surveillance and evaluation system that complements the currently used FDA's passive surveillance approaches through standardizing data capture and quality by electronic health information owners and overseeing the linkage and aggregation of large data sets, among other responsibilities. 

"As device technology continues to evolve and the types of medical devices expand exponentially, we are mindful that the ways in which we assure reasonable device safety must also keep pace," the action plan states. "We must be vigilant in upholding our mission to protect and promote the public health by minimizing unnecessary risks and ensuring that devices provide clinical benefit, and we must assure that consumers, patients, caregivers, and providers have access to the information they need to make well-informed decisions about prevention, diagnosis, and treatment; and we must do so across the Total Product Life Cycle (TPLC) of a device by leveraging the full range of our premarket and postmarket expertise, data, knowledge, and tools at all stages of a device’s development, evaluation, and marketing."

The FDA regulates more than 190,000 medical devices manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide, according to the action plan.