16/17 November 2021
From time to time, the ECA publishes overviews of 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 months.
What are FDA's objectives for the current and the coming year? The document entitled "2016-2017 Strategic Priorities" published by the Center for Devices and Radiological Health (CDRH) provides information about those objectives. In the report, the CDRH starts listing the objectives which could be achieved in 2014 and 2015 like, for example, a clinical trials program and the review of high-risk products resulting in a reduction of data needed for market monitoring.
For 2016/2017, the FDA has defined three priorities:
The national evaluation system based on the analysis of data obtained from market observations should increase medical devices safety. For the FDA, the term "partner with patients" means the greater involvement of patients, e.g. for the development of patient-friendlier package leaflets. The excellence initiative should help create a culture for improving products themselves but also services based on the patient. This also includes the development of "quality metrics" by December 31, 2016 which can be used by manufacturers for the evaluation of products and manufacturing quality beyond compliance with regulatory requirements. By the end of 2016, a voluntary program with the quality metrics should start.
Also the topic data security plays an important part at the FDA. In so far, the FDA has published a (25-page) guideline draft entitled "Postmarket Management of Cybersecurity in Medical Devices". This draft provides monitoring information about what to consider with regard to cybersecurity.
With regard to the sterilisation conditions in marketing authorisations of medical devices (510(k) procedure), the guideline entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" replaces a previous version from 2002. It is interesting to notice that the current guideline had already been available as a draft since 2008.
The FDA sees a rising development of medical devices connected with other (medical) products or technologies. Here, the FDA talks about "interoperability". The design requirements on those medical devices are presented in the guideline draft: Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices.
We have often reported on the Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) system. The CDRH has launched a specific website which provides in-depth information - also in the form of slideshow presentations from the FDA.
To support the recently published guideline draft "Applying Human Factors and Usability Engineering to Medical Devices", the FDA has released another supplementary guideline draft entitled "List of Highest Priority Devices for Human Factors Review" . The document gives a list of medical devices for which also application studies have to be submitted (within a PMA or 510(k) submission). Regarding that topic, you can also find the presentation slides of an FDA webinar.
The FDA has recently published a new CDRHLearn module on Early Feasibility Studies (EFS).
Not specific to the FDA, the revision of ISO 14155 on clinical investigation of medical devices should be interesting for the medical devices industry.