Current FDA Publications for Medical Device Manufacturers

In irregular intervals, the ECA publishes overviews of the FDA's new guidances or draft guidances, webinars, general strategy papers and inspection results concerning medical devices. The following is a selection of the past six months.

The Associated Director for Digital Health of the Center for Devices and Radiological Health, Bakul Patel, conducted a webinar on Mobile Medical Apps (MAA). The webinar also addressed questions on medical device data systems (MDDS). For detailed information please see the webinar "Digital Health" slides.

There is a new draft of a guidance which provides further recommendations for clinical trials regarding electronic media. The guidance also applies to medicinal products for use in humans, to biologicals as well as to combination products.

After a four-year drafting phase, the Guideline for reprocessing recyclable medical devices with regard to validation and labelling is now available. With 44 pages the document is quite extensive, although the last 8 pages are appendices. The FDA also offered a webinar on this guideline. The slides of the webinar "Reprocessing Medical Devices in Health Care Settings: Validation Methods & Labeling - FDA Final Guidance" are also available for download.

A guideline on data collection during the approval procedure has also been published as final version. The exact title is: Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval.

There is also another new draft of a guideline which covers the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States. This draft also addresses study designs and the comparability of the patient populations.

In a Note in the Federal Register the FDA is also withdrawing 47 draft guidelines which are older than 31 December 2013. This is supposed to provide a better overview of the "guideline landscape".

A new guidance has also been issued on Unique Device Identifier (UDI). It describes the Handling of direct labelling of medical devices.

There is now a draft of a guidance on Recommendations on labelling and safety studies of medical devices containing heparin.

Furthermore, there is a draft of a guideline relating to clinical trials (Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions [IDEs]) which addresses the sponsors, auditors of sponsors and the FDA. With 36 pages the document is quite extensive, although the last 10 pages are appendices, which, among other things, also include hypothetical examples.