The Trump administration’s tariff activities provoked another set of responses from both Medtech Europe and the Advanced Medical Technology Association.
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.
In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in this country.”
The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition.
The FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types has provoked some misgivings among industry, with both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasting the draft’s limitations on the scope of the changes that could be included in a PCCP.
The Medical Information Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech.
The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.
Third-party litigation funding has been a source of controversy in the U.S. over the past decade, but the practice drew little national scrutiny up to now.
