AAMI News September 2017

FDA Promotes 'Greater Use' of Standards for Medical Devices

Food and Drug AdministrationThe Food and Drug Administration (FDA) says it is moving ahead with plans to reduce regulatory burdens 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. A key component of this change is providing a rationale for the recognition of a standard—all in the name of transparency and clarity.

“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 in early July.

Most medical device manufacturers rely on consensus standards when 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.

The biggest change in this process, according to Scott Colburn, director of the standards program for the FDA’s Center for Devices and Radiological Health, is that the center is now required to publish its rationale for recognizing or not recognizing a standard in the Federal Register and provide this rationale in writing to the requesting individual or organization.

“Previously, FDA only recognized all or part of a standard but did not provide the rationale (purpose and justification) for such action,” Colburn said. “Cures now directs us to add this to our recognitions, as well as any standards that would not be appropriate for recognition. The significance, I believe, will be full transparency and clarity on the FDA’s position to certain standards and a better explanation as to how/why the standards will support a claim made by a manufacturer.”

In its work plan, the FDA 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 developing safe and effective healthcare technologies.

“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.”