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Compliance In Focus
Posted by John Lehmann on Mon, Sep 10, 2012

NEW!! FDA Issues Device Postmarket Surveillance Plan

In follow-up to our blog on Friday, FDA issued a report entitled “Strengthening Our NationalNew Postmarket Surveillance Plan System for Medical Device Postmarket Surveillance” which is now posted on the website and available for public comment on this preliminary report.

As stated in the news-release, “a key part of this mission is to monitor medical devices and radiological products for continued safety and effectiveness after they are in use and to help the public get the accurate, science-based information they need to improve their health.” Protecting the population at large is the utmost importance of FDA and the medical device industry as a whole. In fact, FDA's Center for Devices and Radiological Health (CDRH) states its mission is to:

  • Assure  that patients and providers have timely and continued access to safety, effective, and high-quality medical devices and safe radiation-emitting products;
  • Provide consumers, patients, their caregivers and providers with understandable and accessible science-based information about the products we oversee; and,
  • Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

As an ongoing goal of FDA transparency, information is widely available for the Postmarket Surveillance Plan, and FDA is encouraging feedback on the preliminary report. Will you be commenting?

What would you suggest to FDA? Share your feedback with us!

Photo Credit: Truthout.org

Topics: Postmarket Surveillance Plan, FDA's Center for Devices and Radiological Heal, FDA


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