FDA's Recent Publications for Manufacturers of Medical Devices

In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new guidelines or draft guidelines, webinars and 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 6 months.

In our GMP News "What's new from the FDA regarding Medical Devices?" from 4 September 2014, we referred to a guideline on "Unique Device Identification System: Small Entity Compliance Guide" which should support small companies with the UDI topic. This guideline has been revised. You can find the corrected guideline here.

Regarding the topic "marketing authorisations" (510k procedure) and clinical studies of medical devices, updated webinar records and their respective slides are available on the CDRH Learn page.

The FDA has released the outcomes of inspections at manufacturers of medical devices from the calendar year 2013. The "finding" number one is deficiencies in CAPA (21 CFR 820.100), followed by deviations i.e. complaints (21 CFR 820.198). This situation corresponds to ECA's statistics as detailed in the GMP News "Medical Devices Warning Letter Statistics 2013 - Rank 1 for CAPA Deficiencies once more" from 12 November 2013, which refers to fiscal year 2013 (1 October 2012 - 31 September 2013), though. The light difference in the evaluation periods explains the lightly diverging results with regard to the results outside the hit list.

Regarding recalls, the FDA has now finalised a draft guideline from 2013 entitled "Distinguishing Medical Device Recalls from Medical Device Enhancements".

The guideline "Design Considerations for Devices Intended for Home Use", originally from August 2014, has been revised and newly released to bring more clarification. Please click here to access the current version.

The FDA has also announced which new guidelines are planned to be published in 2015. A list can be found here. A comparison of the priorities planned for 2014 and an extension to 2015 is available in the 2014 Update of the 2014-2015 Strategic Priorities. The results stated are partly quite impressive.

There are two new guidelines on medical devices and apps. There is now the "Mobile Medical Applications" guideline which replaces that of the same name from 2013 and also the new guideline entitled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" which replace the draft from June 2014.