FDA's Current Publications for Manufacturers of Medical Devices

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7/8 May 2024

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In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. In the following, you will find a selection of the last 4 months.

In a detailed report made of 34 pages, the FDA explains its role in ensuring American patients have access to safe and effective medical devices. The report considers changes over the past five years.

The FDA presents in 143 pages very extensively its recommendations for a national assessment system for medical devices. Among other things, it aims to build a bridge between research and clinical application.

We have already informed about the CDRHLearn in our News. Here again, new modules have been added to the respective webpage where presentations and slides of FDA representatives can be seen. Modules on post-market activities and on workshops about "Purchasing Controls", process validation as well as on CAPA have been newly added.

A very specific guideline draft entitled "General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff" deals with the topic of animal testing in the course of the development of medical devices.

Within 34 pages, the very comprehensive guideline "eCopy Program for Medical Device Submissions" explains the handling of raw data in the course of electronic authorisations of medical devices.