Overview
In September 2023, the US FDA issued regulatory updates, to the guidance on the Innovative Devices Program and preliminary guidance on medical devices associated with weight loss.
Introduction
The US Food and Drug Administration (FDA) has announced new regulatory changes to which health product manufacturers will have to adapt.
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) using 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.
Important Regulatory Changes
- Announced that the Accreditation System for Conformity Assessment (ASCA) will no longer be a pilot program but a permanent one.
- The agency released a final guidance document, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (VIP), designed to assess a medical device manufacturer’s capabilities and performance.
- The FDA updated its guidance document, Breakthrough Devices Program, to expand its oversight to innovative devices that improve accessibility and promote health equity.
- The FDA has issued draft guidance documents on medical devices with indications associated with weight loss.
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References
Learn more about FDA. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.