Home > Transparency Posts > Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available

Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available

December 22, 2010 Leave a comment Go to comments

FDA is taking steps to improve transparency about studies conducted with devices after approval.   The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications.  The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner.

CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study.   The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods.  For completed studies, you can find information about final study results, safety and effectiveness findings, strengths and weaknesses of the study, and recommended labeling changes, if any. 

This post will be last one until January 2011.  Happy holidays to all of our readers and best wishes for the New Year!

Afia Asamoah, Transparency Initiative Coordinator

  1. December 23, 2010 at 4:17 pm

    I think the post approval page is an excellent addition to the FDA website. I have reviewed it and look forward to accessing it.

  2. January 2, 2011 at 6:54 am

    nice blog, im already shared this page to my friend, have a nice day. keep on good sharing,

  3. January 5, 2011 at 5:15 am

    Useful blog and goo sharing,keep it on good way. Happy new year all good stuff.

  4. January 12, 2011 at 1:37 am

    This is a great step towards transparency and making the consumer of medical devices more educated. I hope this webpage will be used by health care professionals to provide the best care to their patients.

    • jean
      July 15, 2012 at 9:14 am

      yah your right i like it

  5. January 29, 2011 at 3:45 am

    Im glad that the public has access to this information as well. Keep up the good work!

  6. January 29, 2011 at 11:36 am

    Yeah i think its a very good idea creating an approval page for each study.
    look forward to your next post after January.

  7. February 9, 2011 at 5:37 am

    Wow, this is really smart. Also – It will become easier with Health Information Exchanges to identify patients using the devices, if there’s a post-approval recall.

  8. March 14, 2011 at 2:16 am

    Wow, this is really smart. Also – It will become easier with Health Information Exchanges to identify patients using the devices, if there’s a post-approval recall.

  9. March 20, 2011 at 8:39 am

    I am only writing to let you know what a terrific discovery my wife’s girl developed using the blog. She figured out such a lot of things, not to mention what it’s like to possess a marvelous giving mood to let the mediocre ones clearly completely grasp a variety of problematic subject areas. You undoubtedly exceeded our desires. Many thanks for producing those productive, trustworthy, explanatory as well as cool guidance on the topic to Janet.

  10. March 20, 2011 at 10:04 am

    Yeah i think its a very good idea creating an approval page for each study.Nice blog, im already shared this page to my friend

  11. March 27, 2011 at 5:51 pm

    I think this is a good idea creating an approval page for each study and
    is a great step towards transparency and making the consumer of medical devices more educated. I hope this page will be used by health care professionals to provide the best care to their patients.

  12. May 26, 2011 at 10:58 pm

    It is a fantastic stage toward visibility and also creating the buyer regarding health-related gadgets a lot more knowledgeable. I am hoping this kind of website will probably be employed by medical care specialists to offer the most effective attention with their individuals.

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    Im glad that the public has access to this information as well. Keep up the good work!

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