Medical Innovation Exchange

remanufacturing

CDRH Releases List of Proposed 2024 Guidance Documents

CDRH Releases List of Proposed 2024 Guidance Documents     Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming …

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FDA CDRH Releases Proposed Guidances for 2023

FDA CDRH Releases Proposed Guidances for 2023     The Center for Devices and Radiological Health (CDRH) has published a list of guidance documents it intends to publish in 2023. The list is prioritized by an “A-List” of documents it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In …

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