Third Party Review of Medical Devices May Be Halted

The FDA is considering halting medical device companies from allowing third parties to review their medical devices rather than the FDA. Initially, allowing third party review of medical devices was thought to quicken the process by which medical devices could be approved for market use. Third party medical device reviews were intended to save taxpayer money. However, the FDA is questioning the quality of the reviews as well as the expense of such processes.
Not all medical devices are eligible for a third party review. The FDA allows such reviews if the medical device in question is similar to a medical device already approved as well as those that pose low to moderate risk to the patient.
The FDA decision to re-consider this process is part of the federal agency’s re-evaluation of how it approves medical devices. Minutes from the December 2009 FDA meeting reveal critiques of the third party process that include a lack of proper expertise as well as a general lack of data analysis. The minutes note that the third party review submissions often regurgitate the content of the submission rather than a critical analysis of that data.
The FDA is expected to make a final determination sometime later this year.