NICE joins FDA to reduce time for medical device approval

NICE, the UK’s National Institute for Health and Care Excellence has announced that it will participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help accelerate patient access to the best new medical devices, diagnostics and other health-related technologies.

The FDA established the PCTF to encourage communication between device manufacturers and payers in an attempt to reduce the time between FDA approval or clearance.

Leeza Osipenko, who leads the NICE Scientific Advice programme said: “In their efforts to get a product to market, companies can get caught out. To win regulatory approval in the US, companies give the FDA data on the safety and efficacy of their devices. But although they often do enough to win FDA approval, they need additional evidence to prove to the organisations who would actually pay for those devices that they are cost-effective and clinically-effective.”

Osipenko explained that NICE’s Scientific Advice programme has joined forces with the FDA to help medical technology makers better produce the data needed to obtain regulatory approval and to show the value of their products.

NICE’s involvement may consist of reviewing the evidence a company is gathering; providing advice in a pre-submission meeting with the other advisory bodies and commenting on the resulting company’s minutes; or producing formal written advice as a follow-up to the pre-submission meeting.