postmarket surveillance

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What Happened to the FDA Request for Transvaginal Mesh Studies?

September 19, 2012 ~ Last January, after a five-fold increase in complications was noted by the U.S. Food and Drug Administration (FDA) concerning synthetic mesh used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA ordered mesh makers to find out why. At the [...]

By |2017-04-20T12:55:49-04:00September 19th, 2012|FDA News|5 Comments

FDA: How to Follow Medical Devices?

Public Invited to FDA meeting on Postmarket Surveillance Barcode, Wiki, author, Maly LOLek September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and [...]

By |2012-09-04T11:17:50-04:00September 4th, 2012|FDA News|0 Comments

Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where's the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, [...]

By |2012-02-14T14:36:17-05:00February 14th, 2012|FDA News|2 Comments