Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., made a string of announcements aimed at further streamlining the medical device approval process on Wednesday.
In the first, Gottlieb said CareFirst BlueCross BlueShield and UnitedHealth Group are joining the Private Payor Program. Created earlier this year, the Private Payor Program facilitates communication between health technology assessors, both public and nongovernmental, payers, and device manufacturers.
Through this program, the FDA hopes to inform manufacturers what evidence they must generate about their devices, which can “shorten the time between FDA approval and coverage decisions.”
Today at Medical Device Innovation Consortium Annual Public Forum, I gathered with stakeholders to announce new #FDA initiatives: expanding payor coverage discussions, clarifying our approach to benefit risk decisions in innovative med tech. https://t.co/0x3WbFhGLU— Scott Gottlieb, M.D. (@SGottliebFDA) September 5, 2018
“This can be particularly beneficial for manufacturers creating new and innovative devices who also need to secure coverage of their devices by payors,” Gottlieb wrote.
This brings the number of payers participating in the program to five. The three others are BlueCross BlueShield Association, Humana, and Kaiser Permanente.
The FDA also released draft guidance today to “systematically address uncertainty" during its approval process, Gottlieb said at the Medical Device Innovation Consortium’s Annual Public Forum.
This policy aims “to support premarket decisions that are based on the totality of scientific evidence available at the time of a device’s market entry,” he added.
During the same remarks, Gottlieb said the agency will release the pilot edition of a tool called “QUiK Review.”
The commissioner described this as “a Turbo Tax for information submitted in 510ks”—the documents that show the FDA a premarket device is safe and effective. The new tool will create a streamlined electronic format for applicants to submit the necessary information.
The announcements fall in line with Gottlieb's broader efforts to create a more modernized, less burdensome approval process. In doing so, Gottlieb hopes the FDA and its partners can “more effectively identify opportunities, challenges and approaches to access, and maximize our collective resources to get beneficial devices to patients.”
In the months to come, Gottlieb said the FDA will update the public about its work to strengthen medical device cybersecurity, focusing on prevention and response to vulnerabilities and attacks. Security breaches have likely caused harm to hundreds of patients using medical devices, according to a report released earlier this year. But one-fifth of device manufacturers and provider organizations have not implemented the FDA’s guidance to protect against such attacks.
Medical device recalls reached an all-time high in the first quarter of 2018, due, in part, to software bugs, errors, and other issues.