ARTICLE SUMMARY:
In this week’s Pathways Picks: The International Medical Device Regulators Forum meeting opened in Washington DC; Brazil updates regulation; the EU Parliament approves the AI Act; Congress snipped FDA’s budget this year, but the Biden administration is asking for more in 2025; physicians get partial reprieve from Medicare cuts; FDA clarifies cybersecurity demands; and more from the US and Europe.
Global Picks
IMDRF meeting and Brazil update:
Craving global reliance. Achieving more routine global regulatory “reliance” was the dominant theme of discussion during the two-day open portion (March 11-12) of the 25th sessions of the International Medical Device Regulators Forum in Washington DC. Reliance is when a regulatory authority in one jurisdiction gives significant weight to assessments performed by another authority or trusted institution in reaching a decision. A key component of the concept is that the relying authority retains the final decision-making (as opposed to situations where the authority lacks a regulatory framework and a foreign certification stands in for access in that country). The practice is already employed in the IMDRF-launched Medical Device Single Audit Program (MDSAP) or by select countries, for instance, Australia, that designate an easier regulatory path for devices with certain trusted foreign certifications (e.g., CE mark, FDA approval, etc.). But regulators and industry members alike said during the meeting that much more can and should be done to make the device regulatory process more efficient for governments and companies alike. Several speakers called on IMDRF to consider developing a “playbook” to lay out a standard approach to employing reliance, potentially building on work by the World Health Organization, which has released documents on Good Reliance Practices and Good Regulatory Practices to help developing countries build frameworks.
