FDA says Essential to Strengthen Post-Market Surveillance of Medical Devices

by Ryan L. Thompson on 09/26/2012

The Food and Drug Administration recently released proposals to implement the improvements that it has in mind for the post-market surveillance of medical devices.  Texas defective medical device lawyers will find the proposalsoutlined in the report titled Strengthening Our National System for Medical Device Post-Market Surveillance.

In the report, the Food and Drug Administration outlines 4 main actions that it believes will help strengthen post-market surveillance of medical devices.  The current system for post-market surveillance is already very well established, but the Food and Drug Administration outlines 4 areas where improvements can be made.

  • The agency wants to establish a unique device identification system which will be incorporated into the electronic health information database.
  • The Food and Drug Administration is also calling for the development of national as well as international medical device registries.  The registry will only contain certain devices.
  • The agency is also calling on a reorganization of the current system in place for reporting and analysis of defective medical devices and adverse events.
  • It is also calling for the development of new methods for the generation of evidence, synthesis and appraisal.

The Food and Drug Administration understands that its proposals are very wide reaching, and cannot be implemented by the agency alone.  The agency is inviting the active participation of many other vested interests, including patients, academia, medical device manufacturers, health care providers, hospitals and healthcare facilities.

The Food and Drug Administration also says that an effective medical device post-market surveillance system should provide timely as well as accurate assessments of the benefits as well as risks of medical devices, should identify potential safety issues using a variety of sources, must reduce the cost of post-market surveillance, and facilitate the approval of new devices.

Tags: Medical Device Mass Torts, Mass Torts

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