FDA Makes Massive Update to Recognized Device Standards

Posted 29 January 2014 | By Alexander Gaffney, RAC 

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released a massive update to its list of recognized third-party standards-its second in the last two weeks.


Standards for the proper manufacture of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.

The process, known as Incorporation by Reference, involves FDA formally recognizing those standards in the Federal Register, which it does several times each year.

New Standards, Old Updates

On 29 January 2014, FDA released its 34th update to its list of recognized standards. Unlike its 33rd update, which affected just 46 standards (five new), the latest update includes hundreds of changes and nearly two dozen additions.

The majority of those changes reflect standards which had been withdrawn, replaced with a newer version or simply extended.

Those standards affect the categories: anesthesia, biocompatibility, cardiovascular, dental/ENT, general, general hospital, general plastic surgery, in vitro diagnostics, materials, neurology, OB-GYN, gastroenterology, urology, ophthalmic, orthopedic, physical medicine, radiology, software and informatics, and sterility.

The update also includes dozens of newly recognized standards, including 17 for orthopedic applications, two for managing risks in medical device-related IT networks, three for ensuring the sterility of dosimetry systems, two for condoms, and a host of materials standards, among others.

All standards are available through FDA's searchable database, located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .

Federal Register Notice

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