ARTICLE SUMMARY:
In this week’s Pathways Picks: Key takeaways from MDMA's annual meeting in DC, including the first post-Trump public appearance by the CDRH director and comments from a top CMS official on medtech coverage; CDRH FOIA staff returns, while industry educators never left; Switzerland pursues efforts to rely on US FDA; and more global medtech policy news.
MDMA Picks
Tarver’s first appearance, and more from MDMA’s annual meeting:
Device chief urges patience. CDRH Director Michelle Tarver was careful not to comment directly on recent layoffs or other specific challenges she is facing under the Trump administration during her first post-January 20 public appearance at the Medical Device Manufacturers Association annual meeting in Washington DC May 1. But she did obliquely reference the ordeal in her closing comments in an on-stage exchange with MDMA CEO Mark Leahey. “I encourage you all to be patient with us. There is a lot happening. We ask that you be patient with us,” Tarver said. “We are committed to meeting our goals, and committed to continuing to advance public health.”
More from third parties? During the MDMA session, Leahey asked Tarver about the 510(k) Third Party Review Program. It’s a long-running CDRH effort that has the potential to support a reduced-resource agency. But after 20-plus years and multiple reassessments, the third-party review program hasn’t gained momentum, based in part on a perception by companies that it doesn’t actually save time or resources in many cases. Tarver says CDRH is taking another look to improve or expand the offering. “We are just looking for ways in which people can get reviews done in a way that is timely,” Tarver said. “If third-party review is an attractive option, then we want to look at things on our side that can facilitate that as an option for companies. We are looking at the program now. We are trying to find ways to enhance it.”
