Lighting A Path For Innovation
Ensuring regulatory processes for medical technology that are efficient, predictable and transparent is essential for innovation to thrive and patients to benefit, and is the core focus of AdvaMed’s Technology and Regulatory Affairs department (T&R).
In 2017, the department’s signature accomplishment was spearheading successful reauthorization of the FDA user fee program for medical devices and passage of other pro-innovation reforms under the FDA Reauthorizaton Act (FDARA), in close collaboration with AdvaMed’s Government Affairs department (see the “Advocacy In Action” section for details). However, the T&R department also achieved a number of other significant regulatory policy successes during the year:
Software & Digital Health
AdvaMed worked with members of the Digital Health Sector and Software Work Group to provide significant input toward FDA development of a precertification software pilot program, announced in July. The program has the potential to reduce pre- and post-market burdens for both software developers and FDA, and enable streamlined changes and modifications to software products. FDA’s release in October of a final guidance, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” was also heavily influenced by AdvaMed.
510(k) & Pre-Market Processes
AdvaMed’s 510(k) Working Group collaborated with FDA in creating the agency’s October guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device.” The document reflects AdvaMed’s recommendations for considering the role of the Quality System Regulation when determining when to file a 510(k) for a device change, and is expected to reduce the number of required 510(k) submissions while speeding access to safe and effective medical devices.
AdvaMed also secured a one-year implementation delay of the final intended use regulation, which would have imposed a sweeping totality of evidence standard for a manufacturer’s intended use and created a chilling impact on truthful device communications, to the detriment of public health. In further progress, FDA issued several draft guidances outlining proposed safe harbors for off-label and pipeline communications.
21st Century Cures
The T&R department’s advocacy efforts for appropriate implementation of the 21st Century Cures Act led to exemption or partial exemption from 510(k) requirements for over 1,000 Class I/II products, nearly all of which were included in AdvaMed recommendations. In addition, AdvaMed provided industry survey report feedback to FDA on the agency’s implementation of “least burdensome” regulatory principle requirements to aid assessment of the effectiveness of related training.