- October 19, 2018
The 17-page document is split up into five sections that address the aforementioned topics plus the creation of a patient safety net, integration of pre and postmarket oversight and steps the FDA could take to intervene faster when safety threats arise. Collectively, the proposals are intended to ensure technological advances translate into safer devices, not just more efficacious products. That thinking is at the heart of the FDA’s plans to incentivize the development of safer devices. As the FDA sees it, manufacturers currently lack incentives to make new or existing devices safer unless they face an emerging safety concern. The Agency wants to use its powers to change that.
Commissioner Scott Gottlieb, M.D., and his Medical Device Team are still figuring out exactly how the agency should intervene; however, the action plan sketched out some possibilities. One option is to expand the kind of extra support the FDA provides through its breakthrough program to advances focused on safety, not efficacy. The FDA sees planned changes to the 510(k) program helping, too.
Another section of the document deals with pre and post-market actions the FDA could take to boost cybersecurity. These include making manufacturers share details of their ability to patch security flaws in premarket submissions and creating a cybersecurity SWAT team to investigate breaches.
The FDA forsees the team, dubbed the CyberMed Safety (Expert) Analysis Board (CYMSAB), being a public-private partnership that acts as a resource for the agency and companies it regulates. CYMSAB would assess vulnerabilities and propose mitigating actions before problems arise, and carry out field investigations when the FDA or manufacturers suspects a device has been compromised.
REFERENCE: Fierce BioTech; 18 APR 2018; Nick Paul Taylor