Oct 14, 2011

US medical device industry lobbying efforts against current regulatory practices appear to be working. A bill introduced in the US Senate would require the US Food and Drug Administration to expedite medical device review times and subject the agency’s Center for Devices and Radiological Health’s (CDRH) regulatory processes to third-party review to assess their impact on innovation.

The Medical Device Regulatory Improvement Act would amend the Federal Food, Drug and Cosmetic Act in several ways:

  1. Changes to the FDA’s premarket approval process would require reviewers to consider alternative methods of evaluating safety and effectiveness of devices in order to reduce approval time frames and costs, and to consider whether pre-clinical rather than clinical data can be used to determine approval of some devices.
  2. New substantial equivalence determination rules would require the CDRH to focus only on whether a device submitted for clearance has the same intended use as its predicate device and is “as safe and effective as a legally marketed device,” and would forbid reviewers from requesting or accepting data irrelevant to the substantial equivalence determination process. In addition, reviewers should examine device labeling for assessing intended use, and “shall not evaluate issues that do not present a major impact on the intended use as set forth in the labeling.” The bill also would require reviewers to consider alternatives to substantial equivalence evaluations to reduce time and cost of the process.
  3. The bill would also require a management and innovation review at the CDRH 60 days following its implementation. Carried out by a third-party entity, the review would examine all management and regulatory practices at the CDRH to ensure that the unit operates with a clear understanding of how its determinations impact innovation. One year following appointment of the third-party entity to the CDRH review, the entity would submit a report of its findings to Congress.
  4. To address conflicts of interest, the bill would subject all advisory committees providing input to the FDA to provisions of the Ethics in Government Act of 1978 covering federal and special government employees.

Congressional interest in the US medical device regulatory process has increased steadily over the past several months. If it becomes law, this bill would stand as a substantial victory for industry advocates arguing that the FDA’s review process has hurt medical device manufacturers.


  • Stewart Eisenhart