Devices

MDSAP Participants Sought

The FDA Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is inviting medical device manufacturers to participate in the regulatory single audit program. An online invitation says an MDSAP pilot opened 1/1/14 and is the implementation of an International Medical Device Regulators Forum MDSAP initiative. The transition to full program implementation is expected to begin 1/1/17.

Countries represented in the program are Australia, Brazil, Canada, Japan, and the U.S.

“MDSAP enables medical device manufacturers to contract with an MDSAP authorized auditing organization to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities,” the notice says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome