FDA updates device consensus standard list with digital health, biocompatibility and sterilization standards

The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, sterilizing products using radiation and using certain materials and alloys.

FDA published tables on 1 August listing voluntary consensus standards that are either withdrawn, replaced, corrected or are newly recognized, to help sponsors align with the agency’s expectations when they submit premarket applications for medical devices and diagnostics. They represent standards recognized by the agency but developed by other organizations, including the International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM) and American National Standards Institute (ANSI).

“FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency is recognizing for use in premarket submissions and other requirements for devices,” the agency said in announcing the updated standards list. “FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the agency’s searchable database.”

The table of modified standards recognized by FDA includes withdrawn and replaced standards that cover devices and topics such as anesthesiology, biocompatibility, quality systems and risk management and in vitro diagnostics.

Similarly, the table of new consensus standards recognized by FDA includes standards for products and topics that cover anesthesiology, obstetrics and gynecology and certain general standards that address issues such as validating the computational performance of products.

Notably, the list of new standards has a significant portion of it dedicated to new software and informatics standards, several of which address cybersecurity and interoperability. That should come as no surprise since cybersecurity and interoperability have been top of mind at the agency with the exponential growth of the digital health sector in recent years.

Topics such as biocompatibility of materials and alloys and sterilizing medical products have also been key topics of discussion at FDA in recent years. The agency has published recent guidances on how to evaluate the biocompatibility of implanted devices. (RELATED: FDA releases draft guidance for non-spinal orthopedic bone fixation devices, Regulatory Focus 23 March 2023)

The list also includes a new version of an ASTM standard on sterilizing health care products with radiation, which comes as the agency has worked to address concerns about proposed limits on ethylene oxide (EtO) that is commonly used as a sterilizing agent. The agency has taken steps to encourage medical device makers and sterilizers to validate other sterilization methods, including radiation and low-temperature vaporized hydrogen peroxide, and methods for how to test porous packaging materials act as microbial barriers.

List of updated consensus standards

FDA updates device consensus standard list with digital health, biocompatibility and sterilization standards

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