FDA's Medical Device Innovation Initiative, a priority review program for breakthrough medical devices, is the subject of a recent eight-page AdvaMed document. Signed by Janet Trunzo, executive vice president of technology and regulatory affairs, it includes praises and a detailed critique of the FDA effort.

“AdvaMed is encouraged that FDA is continuing its recent trend of focusing on steps to foster innovation and improve American competitiveness,” the document states early on.  “AdvaMed also agrees with the position taken in the report that “regulatory pathways should accommodate and facilitate the iterative, cyclical nature of device design and development.”

However, AdvaMed also states that the one or two devices CDRH chooses to focus on annually as part of the initiative will be insufficient and that the CDRH “could expand the proposed priority review program to expedited devices and devices approved through CDRH’s Humanitarian Device Exemption (HDE) pathway, and then ultimately expand the program to all devices.”

The AdvaMed document is expansive and includes specific comments on each of the three major components of the FDA initiative.

While it’s true that FDA is to be commended for its initiative, the agency also needs to answer AdvaMed’s challenge to broaden the initiative to include all devices.
As the shoe commercial boldly states, “Just do it.”