The FDA said a “least burdensome” approach should be applied throughout the medical device product lifecycle, rather than just in premarket regulatory decisions.
The FDA intends to provide significant updates to its 2002 least burdensome guidance as provisions in the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act “further recognized the role of post-market activities as they relate to premarket decisions.”
The FDA and industry share a responsibility to rely more on post-market activities, such as post-approval studies and post-market surveillance, when using the least burdensome approach in order to ensure timely patient access to safe and effective medical devices, the agency said.
“Through the application of the least burdensome approach, we’ve moved much closer to achieving our vision of patients in the U.S. having access to high-quality, safe and effective medical devices of public health importance first in the world,” said FDA Commissioner Scott Gottlieb and CDRH Director Jeffrey Shuren in a blog post.
One major change to the 2002 guidance is how “least burdensome” is defined. It was previously defined as: “A successful means of addressing a premarket issue that involves the most appropriate investment of time, effort, and resources on the part of industry and FDA.” The agency wants to change it to: “The minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.”
The policy updates would expand the approach to include de novo requests; investigational device exemption applications; major deficiency letters; device reclassifications; and guidance documents, among several others.
The new least burdensome guiding principles include:
“Striking the right balance between premarket and post-market information needs is a key principle of the least burdensome concept,” the agency said. “This balance is intended to address obtaining the minimum necessary information at the right time in the total product lifecycle.”
The draft also provides more examples for applying the principles. These include how to leverage existing data, such as peer-reviewed literature, to inform regulatory decisions. The agency also offers new details on the use of real-world evidence from sources like electronic health records. The FDA issued final guidance on using RWE to inform regulatory decision-making in August (IDDM, Sept. 1, 2017).
For industry, clarifications were added on reducing redundancies in marketing submissions to limit the amount of regulatory information in need of review, and using medical device development tools (MDDTs) to reduce costs and review times.
The agency cleared the Kansas City Cardiomyopathy Questionnaire — a clinical outcome assessment questionnaire for measuring patient-reported outcomes — earlier this year, as the first MDDT in the voluntary program for stakeholders (IDDM, Oct. 27, 2017).
It also recently drafted guidance to encourage using the 510(k)-Clinical Laboratory Improvement Amendments waiver dual application pathway for new in vitro diagnostic devices, arguing it enhances the submission process for both the agency and industry (IDDM, Dec. 1, 2017).
Read the full draft guidance here: www.fdanews.com/12-22-17-LeastBurdensome.pdf. — Ana Mulero