FDA update – May 5, 2011

FDA Might Make Failed Medical Device Information Available to the Public

Learning from the failures of others is one of the building blocks of scientific discourse, and medical device companies may soon gain access to an important resource from the FDA that could offer substantial insight when it comes to device development.

FDA is considering making public files that describe failed medical devices and drugs.
Reasons behind FDA’s new policies are:

  • Companies might analyze the information and cut significant time from their own research and development in the same areas.
  • The initiative would provide a glimpse at regulatory pathways that have been unsuccessful for other companies pursuing similar products or areas of care.
  • This would allow medical device developers to focus their efforts on regulatory strategies that offer their products a greater chance of approval, potentially eliminating lengthy delays in bringing a device to market.
    At the same time, companies would object to their proprietary information being shared on a public stage with competitors.

In spite of the reflexive response that states private companies have the right to maintain a blanket of secrecy surrounding their development practices, information submitted to the FDA in the form of trial data and regulatory applications is essentially part of the public record, and it makes sense for this information to be shared throughout the medical industry in order to advance health sciences as much as possible.

The FDA has yet to announce whether it will consult with companies regarding the potential release of failed medical device information, or whether it will make the decision one-sidedly.

In some ways, the situation is comparable to the decision made by the FDA to open up its post-marketing surveillance data to the public, as well as the establishment of the ClinicalTrials.gov website in 2007 which offered public reporting of clinical trial results.

Hence, Medical device companies may feel that this type of valuable data could potentially outweigh organizational concerns about proprietary information being disseminated, and that the FDA initiative is pointing towards the increasingly transparent operations of the Administration a trend that will, over the long term, benefit the entire industry.

For more information you can contact mdi at info@mdiconsultants.com REF: failed Medical Device Information Available to the Public