FD&C Act Archives - Medical Innovation Exchange

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

Leave a Comment / counterfeit device, FD&C Act, Final Guidance, Medical Device, MedTech, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, regulatory documents / By Inga Hansen

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …

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FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

Leave a Comment / Deficiences, FD&C Act, FDA, guidance documents, Medical Device, MedTech, Quality/Regulatory, statement of basis / By Inga Hansen

FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions The FDA has updated its final guidance: “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.” The new guidance, which supersedes “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions” issued in 2017, is intended to help FDA …

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FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

Leave a Comment / FD&C Act, FDA, Medical Device, MedTech, PAS, post approval studies, postmarket surveillance, Quality/Regulatory, section 522 / By Inga Hansen

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices. Per the FDA announcement, these guidances are “intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under …

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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

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