The US FDA has implemented significant regulatory changes for medical device manufacturers:
- The Accreditation Scheme for Conformity Assessment (ASCA), previously in a pilot phase, has transitioned into a permanent initiative as of September 19, 2023. ASCA is a voluntary program designed to streamline the premarket review process. Its primary objective is to instill confidence in the Declaration of Conformity (DOC) by involving accredited testing laboratories.
- The FDA has issued a final guidance document titled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (VIP).” This guidance delineates the policy for participating in the Voluntary Improvement Program (VIP), which assesses the capabilities and performance of medical device manufacturers through third-party evaluations. The program aims to facilitate enhancements that elevate the quality of medical devices.
- Updates have been incorporated into the guidance document for the Breakthrough Devices Program. These revisions broaden the program’s scope to encompass innovative technologies and devices that enhance accessibility and advance health equity. The updated guidance provides clarity on the FDA’s approach to evaluating technologies and device features that can mitigate healthcare disparities and offer more effective treatment or diagnosis for affected populations.
- The FDA has released draft guidance documents about medical devices associated with weight loss indications. These documents are divided into two sections: “Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations” and “Medical Devices with Indications Associated with Weight Loss – Clinical Study and Benefit-Risk Considerations.” They offer recommendations for non-clinical testing to support premarket submissions for such devices and provide insights into clinical study design, including discussions on how the FDA assesses the benefit-risk analysis for these indications.
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