FDA Promotes ‘Greater Use’ of Standards for Medical Devices


Posted July 25, 2017

The Food and Drug Administration (FDA) says it is moving ahead with plans to reduce regulatory burden and promote medical device innovation as required by the 21st Century Cures Act, including changes to the way it recognizes voluntary consensus standards for medical devices.

“Greater use of nationally and internationally recognized standards will promote more efficient and consistent device review, and will reduce the burden on manufacturers from inconsistent standards in use by different international regulatory authorities,” the FDA stated in its 21st Century Cures work plan, which was made public earlier this month.

Most medical device manufacturers rely on consensus standards while developing and testing their products, and the FDA allows manufacturers to submit a “declaration of conformity” to those standards to help facilitate the review process.

The FDA has already recognized more than 1,200 national and international standards developed by organizations such as the International Organization for Standardization, American National Standards Institute, International Electrotechnical Commission, and AAMI.

Under the new process, any “interested party” may submit a request for the FDA to recognize a specific standard developed by a nationally or internationally recognized standards development organization. The agency then has 60 days to make a decision to recognize all, part, or none of the standard.

After that, the FDA is required to issue a written response to the requesting individual or organization that includes the rationale behind its decision. This rationale also will be published in the Federal Register. More information about submitting a request for recognition can be found on the FDA’s website.

In its work plan, the agency also noted that it intends to expand its participation in national and international standards setting organizations across topics such as cybersecurity, robotics, software, and additive manufacturing.

AAMI President and CEO Robert Jensen said the FDA’s plan underscores the pivotal role that standards play in healthcare technology.

“The medical device industry is facing a rapidly changing regulatory landscape both in the United States and abroad,” Jensen said. “The use of consensus standards can be an effective means to navigate that terrain and help bring innovative and life-saving products to market faster.”