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Regulatory Briefs: Consensus Standards; Penalty Amounts Increase; Biologics Center Seeks Branch Chief

FDA adds 53 entries to the list of standards it will recognize for device pre-market submissions, and grants de novo approval for two device types. Civil money penalty amounts increase on inflation adjustment. The Center for Biologics Evaluation and Research searches for a review branch chief. More regulatory news.

The agency on Jan. 30 announced changes to the long list of consensus standards it will recognize for use in medical device pre-market submissions. Along with hundreds of withdrawals, corrections and revisions, the list includes 53 new entries. The newly recognized standards fall under the categories of anesthesia, cardiovascular, general, general hospital/general plastic surgery, material, ob-gyn/gastroenterology/urology, ophthalmics, orthopedics, radiology, software/informatics and sterility.

The updated list appears in Recognition List Number: 034, and is effective immediately. The standards were all developed by international and national organizations, and are important to manufacturers...

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