Jun 14, 2011

The US Food and Drug Administration (FDA) has floated the possibility of reorganizing the Center for Devices and Radiological Health (CDRH) and providing more resources to the branch in order to address issues in order to improve product review processes and meet the goals of the Medical Device User Fee and Modernization Act (MDUFA) reauthorization next year.

Agency representatives disclosed these suggestions at a May 4 negotiating meeting with the Advanced Medical Technology Association (AdvaMed), the Medical Imaging Technology Alliance (MITA), the Medical Device Manufacturers Association (MDMA) and the American Clinical Laboratory Association (ACLA). Minutes of the meeting were recently posted on the FDA's website.

The May 4 meeting follows the FDA’s unveiling of a proposal package for improving review processes and meeting MDUFA III goals at an April 13 negotiation meeting. Those proposals include:

  • Improving device review performance via changes to premarket approval (PMA) goals
  • Improving PMA review consistency and predictability
  • Strengthening scientific infrastructure at the CDRH through better staff retention and more hiring in bottleneck areas
  • Improving review management
  • Providing clearer definitions of submission acceptance criteria

To meet these goals, FDA officials at the May 4 meeting explained that the CDRH would require 254 additional full-time equivalent staff as well as a bigger operating budget—to be funded partially via higher user fees, presumably.

Industry responses to the agency’s proposal package were mostly oppositional. Attending representatives questioned the FDA’s need to add additional staff, arguing that user fees established under MDUFA II were partially meant to cover staffing requirements. Industry groups also disputed FDA contentions that poor submission quality has partially contributed to missing MDUFA goals in the past, arguing that improper risk-benefit calculations and inexperienced agency reviewers were primarily to blame for missing those goals.

Such contrasting viewpoints as to how to improve the FDA device review process should hardly come as surprising given how vigorously regulators and the industry have staked out their positions on the issue. The next negotiation meeting, which occurred on June 1, was to entail submission of complete sets of proposals by both the FDA and industry, as well as draft commitment letters. It’s doubtful the two sides’ documents will have much in common.


  • Stewart Eisenhart