Nov 17, 2011

US consumer advocacy group Consumers Union is arguing that Congress strengthen the Food and Drug Administration's ability to regulate medical devices in order to improve quality, safety and effectiveness.

The group has sent a letter to Congress contending that despite industry lobbying efforts casting medical device regulations as barriers to innovation, devices remain less regulated than pharmaceutical products in the US.

The Consumers Union letter also takes issue with the FDA's practice of clearing most devices through the 510(k) process without requiring clinical trials, as well as the agency's reliance on Substantial Equivalence as a key consideration during device reviews.

Recommendations for pre-market approval improvements the group's letter imparts to Congress include:

  • Replace "reasonable assurance" safety requirements for devices with "substantial evidence" requirements currently in place for drugs
  • Require all implantable and life-sustaining devices to go through premarket approval rather than 510(k) clearance
  • Remove all recalled devices from list of predicates to prevent other devices from being cleared based on those recalled devices
  • Require all devices cleared using a recalled device as their predicate to undergo safety reviews

Consumers Union also argues for improvements to the FDA's post-market surveillance practices for devices:

  • Implement a nationwide unique identifier system for devices for better communicating to patients and providers when device problems arise
  • Providing the FDA with adequate resources to fully implement and enforce existing patient protection initiatives such s MedWatch, MAUDE and Sentinel
  • Empowering the FDA to require longer-term post-market studies, and to require manufacturers to fully meet their post-market surveillance obligations
  • Keeping current conflict of interest rules for federal advisory committees in place

These recommendations are not new, according to Consumers Union: along with other consumer advocacy organizations, the group argued for adoption of these steps five years ago.

Given the substantial resources and legislative connections industry lobbyists have at their disposal, however, Consumers Union will likely have to make the same argument in another five years.


  • Stewart Eisenhart