FDA unveils action plan to improve medical device safety

18 April 2018 (Last Updated April 18th, 2018 11:06)

The US Food and Drug Administration (FDA) has unveiled a new action plan to ensure the safety of medical devices and patient protection while also driving innovation.

The US Food and Drug Administration (FDA) has unveiled a new action plan to ensure the safety of medical devices and patient protection while also driving innovation.

Titled ‘Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health’, the proposal seeks better cybersecurity for devices with new and advanced technologies.

In addition, the agency will work towards the optimisation and implementation of post-market mitigations, and a combination of pre- and post-market activities to track the total product life cycle (TPLC) of devices.

The FDA wants to ensure that products will meet the commercialisation gold standard during their entire life cycle.

“New technologies that could make devices safer will be explored, along with ways to permit comparative safety claims to prompt competition for improving the safety features of products.”

A statement by FDA Commissioner Scott Gottlieb read: “To deliver reasonable assurance of safety and effectiveness for certain highly complex technologies, we may need to require additional training or user education.

“To do this efficiently under our existing authorities, we’ll consider issuing an umbrella regulation to identify these devices and mandate these requirements.”

The agency additionally intends to invoke ‘restricted device authority’ on high-risk devices to improve patient protection.

Gottlieb added that the best way to impose these requirements will be considered in order to continue permitting the use of the devices, when necessary.

Furthermore, new technologies that could make devices safer will be explored, along with ways to permit comparative safety claims to prompt competition for improving safety features of products.

The action plan will also see new registries and Women’s Health Technologies Strategically Coordinated Registry Network (CRN) which is focussed on clinical areas unique to women.

Gottlieb noted that the agency will seek additional funding and authorities from Congress for advancing medical device cybersecurity. A new public-private CyberMed Safety Analysis board will be established to support the FDA as well as device manufacturers on improving the security.