The FDA is seeking companies to take part in a pilot program that would allow medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis. This pilot program will help the agency develop criteria for quarterly malfunction reporting submissions in the future.

Up to nine companies may take part in the pilot program, which is intended to run for six months.

The FDA will begin accepting nominations for participation in the voluntary pilot program on September 1, 2015, and intends to continue to accept nominations until candidates for the pilot program have been selected.

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