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 Note: The email sent on June 27, 2022, included an incorrect date for the comment period on the Draft Guidance: Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program. The correct date is listed below.
Draft Guidance: Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
On May 5, 2022, the FDA issued a draft guidance that, when finalized, is intended to describe the FDA’s policy on its participation in the Voluntary Improvement Program. The Voluntary Improvement Program is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturers' practices using third-party appraisals to enhance the quality of devices. This program is intended to guide improvement to enhance the quality of devices.
Read and Comment on the Draft Guidance. Submit comments by July 5, 2022.
We help our stakeholders navigate the FDA's current policies on digital health products and provide informal feedback on the possible regulatory status of products in development. Please contact us with your questions.
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For questions about digital health regulatory policies, visit our website for helpful information and more on how to contact us.
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For general Digital Health Center of Excellence questions, please email digitalhealth@fda.hhs.gov.
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