American and European regulators are moving toward more regulatory convergence under the newest iteration of the Transatlantic Trade Investment partnership.
The FDA and its European counterparts have worked closely together over the years to hammer out international standards and to share data amongst themselves.
That effort appears to be paying off. A new annex on medical devices supports international efforts to establish a globally accepted unique device identification system for devices.
The annex lays out principles and objectives that focus to promote convergence of technical and clinical requirements for medical devices. The agreements would remove unnecessary duplications of data submissions and device testing and manufacturing site inspections.
Standards play a key role in the convergence process, and the agreement calls for recognition of international organizations such as the International Medical Devices Regulators Forum (IMDRF) , the International Organisation for Standardisation (ISO) and the Global Medical Device Nomenclature.
Both sides are expected to participate in developing scientific and technical guidelines for regulating devices in IMDRF. Cooperation is expected to result in more international standards, guidelines and joint initiatives.
FDA noted that EU counterparts also acknowledged the importance of the Medical Device Single Audit Program, and the EC would continue to coordinate and support efforts in EU member states.