UnitedHealth Group and CareFirst have signed onto an FDA pilot allowing device manufacturers to get feedback from regulators and payers during pre-submission meetings, Commissioner Scott Gottlieb said Wednesday.
The announcement was just one of several made in a wide-ranging speech on FDA's oversight of medical devices to a room full of industry executives, high-ranking government officials and trade association leaders.
The goal of the payer pilot, Gottlieb said at the Medical Device Innovation Consortium's annual public forum, is to encourage manufacturers to "develop a more efficient evidence-generation strategy" during the meetings and facilitate a shorter period of time between FDA approval of devices and coverage decisions "particularly for new and innovative devices."
Other members of the program, which currently receives one product inquiry per week, include the BlueCross BlueShield Association, Duke Evidence Synthesis Group, the ECRI Institute, Humana, Kaiser Permanente and the National Institute for Health and Care Excellence in the U.K.
Gottlieb said that while FDA's medical device regulatory paradigm has advanced at a healthy pace, delays by private payers in coverage decisions are reducing incentives for device companies to innovate.
"Insurers have every right to demand good data to support their coverage decisions. And they have an obligation to be good stewards of the healthcare needs of their beneficiaries," Gottlieb said. "But if there are steps that the FDA can take to make that coverage process more efficient, and to make sure payers have the data they need to enable efficient access to beneficial new technologies, we want to do our part to make these opportunities available. Access is a matter of public health."
FDA will also be launching what it is deeming a new "QUiK Review" pilot that Gottlieb says will lower review time for well understood low-risk 510(k) submissions "by as much as 30%." The program will use a more streamlined, electronic submission that offers a more structured format that in theory will allow reviewers to cut down the maximum review time from 90 to 60 days.
In another bid to facilitate medical device premarket review, FDA also issued a new draft guidance Wednesday. The document aims to bring bring clarity to how the agency considers the risk-benefit balance during approval decision making.
"By providing a more systematic review to how we evaluate and address uncertainty — and how we define an acceptable extent of uncertainty — we believe that this sort of transparency can help improve device development programs, especially when it comes to innovation in treatment options for small patient populations, such as medical devices targeted to rare conditions or pediatric patients," Gottlieb said in a statement.
The draft guide notes the agency's obligation under the 21st Century Cures Act to "consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness." Gottlieb noted that overly complex clinical trial requirements risk pushing companies to conduct research overseas, putting "the U.S. at risk of losing its leadership in this fast-moving sector."
The commissioner emphasized that product safety remains FDA's principal obligation, but argued that no "reasonably-sized premarket trial" can provide "absolute certainty about all aspects of how a new product will perform" for PMAs. But in the draft guide, FDA pointed to its risk classification for medical devices, noting that "as a general matter, high-risk and innovative moderate-risk devices will typically need clinical evidence to show reasonable assurance of safety and effectiveness."
FDA lists several considerations for a premarket approval decision in the draft guidance including:
- The probable benefits of a device.
- The extent of probable risks, such as the severity, rate and duration of such risks.
- Uncertainty of the benefit-risk profile of other treatments or diagnostics.
- Patient input on appropriate levels of uncertainty.
- The feasibility of generating "extensive clinical evidence premarket based on appropriate considerations."
- The potential benefit of earlier patient access to a device.
Device cybersecurity is also on Gottlieb's mind. He said that FDA will issue an update to its cybersecurity premarket guidance to equip device makers with recommendations to protect against moderate and major risks such as ransomware campaigns or remote multi-patient attacks.