Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers inspections of medical device manufacturers to promote and continuously improve the quality, safety and efficacy of devices and thus meet the needs of patients and safeguard their health.

The Mutual Recognition Agreement (MRA) between the European Commission and the FDA aims to mutually recognise Good Manufacturing Practice (GMP) inspection systems and reduce the number of inspections. However, such an agreement does not guarantee that there should be no reciprocal controls, especially in the face of problems that the FDA has encountered in recent years while inspecting production sites in Europe. For example, inconsistency and lack of information in the inspection report and lack of quality during post-market surveillance were found, raising concerns about device quality or patient safety. It is precisely for these reasons that the FDA has decided to increase inspections of European manufacturers in particular countries, including Italy, starting from January 2024.

The updated programme aims at guiding FDA staff to conduct inspections of device manufacturers to identify those that do not comply with regulations and bring these organisations into compliance through voluntary, administrative and/or regulatory means, as appropriate.

FDA investigators must inspect manufacturers of Class II and Class III devices using a risk-based methodology. Specifically, pre-market inspections will be carried out under the Medical Device User Fee Amendments (MDUFA). Manufacturers of implantable and class III devices that have never been inspected, manufacturers of devices with a higher frequency of recalls, and manufacturers of devices newly placed on the market with recent 510(k) and De Novo approvals shall be inspected.

This compliance programme also provides specific instructions for tracking as well as registration and entry in the GUDID database.

FDA also makes the Dashboard available, which provides a detailed overview of its activities through easy-to-use and comprehensible tables and charts for a complete analysis. According to the tables and graphs shown, in 2023 and 2022 only 20 and 7 Italian medical device manufacturers, respectively, underwent FDA inspections, a very small number compared to other Member States. Consequently, due to the shortcomings described above, it is assumed that the number of inspections by the FDA may at least double as of January 2024.

>> In anticipation of FDA audits, Thema can perform a gap analysis of the quality management system under 21 CFR 820 et alter. Thema can assist the Manufacturer during the audit and be of support in the post-inspection phase for the resolution of any deficiencies.

Moreover, through the services of strategic-regulatory consulting, 510(k) pre-market notification, De Novo and Premarket approval (PMA) drafting, Thema can support the marketing of Medical Devices in the U.S.A. while complying with FDA requirements.


Compliance Program Manual