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FDA Modifies List of Standards Used in Premarket Reviews


The US Food and Drug Administration has announced changes to its recognized consensus standards used in premarket reviews of medical devices.

Now in effect, the changes include additions, withdrawals, corrections and revisions and are grouped under “Recognition List Number: 027” in the FDA’s searchable database.

Modifications to the FDA’s list of recognized standards affect cardiovascular, ophthalmic, orthopedic, sterility, general and materials categories. New entries and consensus standards added to Recognition List Number: 027 cover multiple areas, including anesthesia, IVD, nanotechnology and ophthalmic categories.

Although the changes have already gone into effect, the FDA is accepting public comment on its modified list of standards on an ongoing basis. Medical device manufacturers planning to apply for premarket reviews of their products should check the revised list of consensus standards to ensure conformity.

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