Current FDA Publications regarding Medical Devices

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In irregular intervals, the ECA publishes overviews about new guidelines or guideline drafts, webinars, general strategy papers and about FDA inspection results regarding medical devices. Following you can read what the authority issued in the last months.

What guidelines the FDA plans on issuing or finalizing as a draft is available in an overview entitled with "Proposed Guidance Development and Focused Retrospective Review of Final Guidance" on the FDA website. The FDA prioritizes in an A and B list. Also included are the guidelines from the years 1977, 1987, 1997 and 2007, which will be reviewed this year.

In the Federal Register the FDA issued comments on the application of the Unique Device Identification System (UDI) regulations. In a letter to the firms labelling medical devices the authority indicated the problems with the UDI system. The agency wants to address them together with industry.

A guideline draft from 2016 has now been published in its final version: "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions". It targets the medical devices industry, but also the FDA itself. On 36 pages the guideline explains benefit-risk considerations regarding defective products or with non-compliance problems. Seven practical examples and three worksheets help to illustrate these complex issues. In addition a webinar was conducted. The materials are available entitled "Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions". The topic benefit-risk considerations - specifically with regard to clinical studies - has now also been finalized in an own guideline: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions. And for this guideline the slides of an accompanying webinar are available as well - see "Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance".

On the topic "Cybersecurity" in the marketing phase the FDA has also finalized a draft from 2016: "Postmarket Management of Cybersecurity in Medical Devices". The document comprises 30 pages and is also valid for medicinal apps. And this guideline was also accompanied by a webinar - and the slides can also be downloaded under "Postmarket Management of Cybersecurity in Medical Devices Final Guidance". Further, the authority also released a Blog for this guideline.

Another draft document on the classification of accessories for medical devices from 2006 was finalized as well: Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types. With 15 pages this guideline is relatively manageable. And there are also webinar slides available - please see "Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types".

On the topic labelling and product information the FDA has also issued a guideline draft comprising 18 pages: Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers. The document is designed as Questions and Answers, Q&As.

For 2017 the FDA has started an interesting programme: CDRH's Experiential Learning Program. The goal of this programme is to enable Center for Devices and Radiological Health (CDRH) staff to get to know new medical device technologies on-site.

The results of their strategic plannings for the years 2016-2017 are described for 2016 retrospectively in a 3-page overview of the CDRH.

The FDA further refers to a website on the subject symbols regarding labelling. There you can find the according guideline as well as a Questions and Answers, Q&As document.

On the CDRH learn site new modules were posted. They relate to technical issues, the marketing of medical devices, but also activities within the scope of routine production (vigilance).