FDA Tweaks List of Recognized Consensus Standards for Devices

A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
 
The 14-page notice “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices,” CDRH said. It includes a list of the modifications to the agency’s database of recognized standards, which aid in harmonization.
 
The types of modifications listed were separated into three categories. These include standards that have been withdrawn and replaced by others, corrections of errors the agency made in previously listing the standards as well as changes to the supplementary information sheets.
 
Some of the recognized standards have been re-approved and reaffirmed as well, including the quality system and risk-management standard ASTM D903−98 on testing adhesive bonds.
 
Several standards for in vitro diagnostic devices are affected, with seven being replaced with newer versions and two—CLSI M27-S4 and CLSI EP09-A3—being withdrawn. Recognized standards for certain materials, including surgical implants and sensor systems, and devices within ten different medical specialty areas may also be impacted by the modifications.
 
A recognized standard is also being withdrawn and replaced with a newer version for certain requirements in the areas of sterility and electrical safety. A second, much shorter list points to the consensus standards added as modifications to the agency’s list of recognized standards.
 
The agency announces “additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary,” CDRH added. These may come per the request of stakeholders, which can provide recommendations to CDRH containing these six elements of information, at a minimum.
 
In draft guidance issued last month, the agency provide new clarifications on the recognition and withdrawal process. A final guidance separately issued in conjunction with the new draft guidance also updates 2014 policies for appropriate use of voluntary consensus standards.