ARTICLE SUMMARY:
In this week’s Pathways Picks: Michelle Tarver is officially named director of CDRH; European lawmaker vote urges MDR revamp; postmarket surveillance bill enters UK Parliament; New Zealand presses forward on device reforms; medtech progress at latest CPT coding meeting; technology assessment updates from the EU and UK; and more.
Top Picks
Tarver on top, EU Parliament votes:
Tarver officially takes CDRH reins. Michelle Tarver, MD, was named permanent director of
CDRH October 22, about three months after she took over for the retiring Jeff Shuren in the acting director role. Tarver, a board-certified and still-practicing ophthalmologist, has worked at CDRH since 2009, where she has led an array of center-wide initiatives, including and in particular programs to advance the use of patient science and engagement. Most recently, she was deputy center director for transformation and previously deputy director of the Office of Strategic Partnerships and Technology. Tarver has held a series of private introductory meetings with industry and patient groups, and representatives of Capitol Hill in recent months, and has also appeared at multiple public events to represent CDRH as its leader, where she has touted the center’s accomplishments and signaled plans to build on them. “As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission,” Tarver said in a statement announcing her appointment.
Parliament vote urges EU reforms. The European Parliament voted in support of a pared down resolution October 23 calling on the European Commission to formally propose reforms to the Medical Device and IVD Regulations by March 31. Specifically, it requests the Commission propose “delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations.” The resolution follows an October 9 debate in the Parliament where multiple members (MEPs) demanded quicker reform action, citing persistent challenges in transitioning legacy devices to the new regulations and getting new devices to market. The Parliament specifies that the proposed reforms should add more binding timelines to the notified body conformity assessment procedures, “eliminate the unnecessary re-certification of products,” and consider fast-track pathways for innovative and emergency-response technologies, among other requests. The resolution is a compromise measure negotiated by multiple factions in the Parliament, and falls short of including some previously floated demands, such as the creation of a centralized governance structure to improve harmonization. Ultimately, it is up to the Commission to present reform proposals before they can be debated and enacted by legislative bodies.
