US FDA Announces Permanent Accreditation Scheme for Conformity Assessment Program

The US Food and Drug Administration (FDA) announced a number of new regulatory changes with which medical device manufacturers should become familiar. First, FDA announced the Accreditation Scheme for Conformity Assessment (ASCA) will go from pilot status to becoming a permanent program. Second, the agency has released a final guidance document, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (VIP), designed to evaluate a medical manufacturer’s capabilities and performance. Third, FDA has updated its guidance document, Breakthrough Devices Program, to expand its oversight to innovative devices that improve accessibility and promote health equity. Fourth, FDA issued draft guidance documents on medical devices with indications associated with weight loss.

FDA announces ASCA as permanent program

FDA has converted its ASCA pilot to a permanent program, effective September 19, 2023. The ASCA is a voluntary accreditation program designed to increase the efficiency of the premarket review process by building confidence in the declaration of conformity (DOC) through the use of accredited testing labs. The ASCA Program will continue to be implemented through the guidance documents posted on the FDA webpage, Accreditation Scheme for Conformity Assessment.

Final guidance on FDA activities and engagement with the Voluntary Improvement Program

FDA issued a final guidance document, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, which describes the policy for participation in the Voluntary Improvement Program (VIP). The VIP, facilitated through the Medical Device Innovation Consortium (MDIC) public-private partnership, evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals and is intended to guide improvements to enhance device quality.

Updates to guidance on Breakthrough Devices Program

FDA updated the final guidance document, Breakthrough Devices Program, to expand its scope to innovative technologies and devices that improve accessibility and promote health equity. Specifically, the amended guidance document clarifies how FDA will consider technologies and device features that may help address healthcare disparities by providing more effective treatment or diagnosis in various populations impacted by such disparities.

Draft guidance on medical devices with indications associated with weight loss

FDA issued the following draft guidance documents on medical devices with indications associated with weight loss:

• Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations
• Medical Devices with Indications Associated with Weight Loss – Clinical Study and Benefit-Risk Considerations

These guidance documents provide recommendations on non-clinical testing to support premarket submissions for these devices and recommendations on clinical study design including discussions on how the FDA considers the benefit-risk analysis to support such indications.