4/5 October 2023
The Center for Devices and Radiological Health (CDRH), responsible for medical devices at the FDA, publishes new guidelines and programmes on a regular basis. Following you will find a short and selected overview of new, modified, or updated guidelines and programmes.
The guideline "Design considerations for pivotal clinical investigations for medical devices" is new. With 57 pages this guideline is very extensive. It is supposed to provide assistance in the planning of clinical trials for medical devices which are subject to a "Premarket Submission". This "Premarket submission" is kind of an approval process for medical devices, and especially with the risk class III (medical devices with high risk). The guideline not only addresses the industry but also FDA staff processing "Premarket Submissions". Anyone looking for information in addition to the guideline may also take a look at the presentation from the CDRH Department of Biostatistics Director on this topic.
Also new is a draft of the guidance document with the title Medical Device Development Tools. This document introduces a voluntary process for the qualification of tools for the development of medical devices. Through the use of these tools, the FDA hopes for a faster evaluation of innovative medical devices in the approval process. In this respect, the draft also addresses the industry as well as FDA staff.
To improve the quality of medical devices, the FDA started the programme "Case for Quality" in 2011. Here you can find a current evaluation of the programme. In connection with "Case for Quality" the FDA also started a Voluntary Compliance Improvement Program (VCIP) pilot case for quality. The programme is designed to provide an alternative to the classical FDA supervision.
The issue of identification of medical devices (UDI) has a high priority at the FDA. We have already reported. Those who want more information now have the chance to look at two presentations on the CDRH website - on the Introduction of UDI and on the control itself.
Furthermore, other changes were made in a list of standards which are of regulatory relevance to medical devices. Under the title "modifications to the list of recognized standards, recognition list number: 033" these changes are listed.
The "Guidance for industry and food and drug administration staff annual reports for approved Premarket approval applications (PMA)" was finalised. It provides assistance in the preparation of annual reports for medical devices under a Premarket Approval Application. With 12 pages this guideline is not very extensive, and 3 pages list the content of an annual report.
Also finalised was the question and answer paper: Questions and Answers about eMDR - Electronic Medical Device Reporting. The 13 pages document supplies information with regard to electronically written reports about adverse events with medical devices.
The now finalised guideline "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meeting with Food and Drug Administration Staff" addresses applicants for clinical trials and for approvals of medical devices. The 57 pages guideline also references applications regarding clinical trials with medicinal products (IND) and approvals of biological medicinal products (BLA).
The draft of the guideline "Humanitarian Device Exemption (HDE): Questions and Answers Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff " comprises special questions with regard to the registration of medical devices which only concerns a very small circle of patients (< 4000 affected per year in the United States).