26/27 May 2021
Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to aspects of quality assurance and marketing authorisation:
The "Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers" should replace the "Medical Device Reporting for Manufacturers" from 1997. Referring to 21 CFR 803, it should provide - in the final version - a current stand of the art of "adverse events".
The FDA gives information about a "Third Party Review Programme for 510 (k) submissions" on a voluntary basis. The topic "Third Party Audits" has been preoccupying the CDRH for a long time now (see for example our GMP News from 13 August 2013).
The guideline on quality of heparin (see our GMP News from 24 July 2013) is also intended for medical devices manufacturers who use heparin.
New too: a guideline which addresses specific application systems with regard to combination products (Guidance for Industry and FDA Staff: - Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products). The guideline deals with aspects relevant for a marketing authorisation and expected by the FDA in a submission.
Read how to proceed if you don't agree with an FDA decision in the guideline on "Appeals Processes" which replaces the following regulations: "Guidance for Dispute Resolution," February 1998 and "Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA," July 2001. In addition, the FDA has released a Draft Guidance which addresses specific topic in a Q&A paper "Health Appeals Processes: Questions and Answers About 517A".
Moreover, in another news we reported specifically about a new guideline on risk-based monitoring of clinical trials. If you are interested in the clinical studies of medical devices, you should read more about the new learning programme of the FDA on the topic on the CDRH Learn Page and the guideline draft "FDA Decisions for Investigational Device Exemption (IDE)".