The Agency that never sleeps

Image credit: Edwin Valencia,  Pixabay

Image credit: Edwin Valencia, Pixabay

On September 5, 2018, FDA Commissioner Scott Gottlieb, M.D., announced several new FDA initiatives designed to improve payor discussions with medical device manufacturers, address cybersecurity, and provide better information as to how the FDA evaluates benefits vs. risks with respect to a patient’s health outcome. 

A pilot program, called “QUiK Review”, has a stated goal of reducing the FDA’s review time “for certain well understood, lower-risk 510(k) submissions by as much as 30% - from a maximum of 90 days down to 60 days” through more efficient receipt and evaluation of pre-market submissions. 

Dr. Gottlieb also said that FDA also considers medical device cybersecurity to be a “high priority” for post-market and pre-market situations, but did not provide specifics beyond to expect recommendations for protecting against “moderate and major” risks, such as ransomware disruptions to clinical operations, and remote exploits targeting patients.

Regarding benefit and risk determinations, Gottlieb mentioned that FDA's draft guidance (“Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions”) will describe the factors that the agency uses for evaluating uncertainty when it applies standards of safety and effectiveness. Factors mentioned included “the availability of alternative treatments, public health need, feasibility of evidence generation premarket, the ability of the sponsor to be able to reduce or resolve uncertainty in the post-market setting, patient perspectives, and other factors”. The draft guidance is available here, and an announcement regarding the public comment period was published in the Federal Register on September 6, 2018.

The FDA would like to expand its use of real world evidence (RWE) to uncover additional device indications. The Medical Device Innovation Consortium (MDIC) will be used to facilitate discussions between manufacturers and payors, and to manage the National Evaluation System for health Technology coordinating center (sic) (NESTcc). NESTcc coordinates with 11 data partners, 150 hospitals and “thousands” of outpatient clinics, representing close to 470 million patient records.