FDA's fall calendar is filling up as the agency reschedules public meetings that were originally planned for spring but postponed when the COVID-19 pandemic took priority.
First up is a virtual, webcasted two-day meeting of the Orthopaedic and Rehabilitation Devices Panel beginning Tuesday to, in part, consider an agency proposal to reclassify non-invasive bone growth stimulators, which are made by companies like Orthofix, Zimmer Biomet and DJO.
In August, the regulator proposed reclassifying noninvasive bone growth stimulators from Class III to the lower-risk Class II category, meaning manufacturers would no longer have to submit for premarket approval (PMA) and could instead pursue the 510(k) pathway to market. FDA said it now has enough experience reviewing the devices, which are used to help heal fractures and in spinal fusion surgery, to establish special controls to mitigate health risks.
Also on the agenda for the meeting Tuesday is a discussion of facet screws systems. On Wednesday, the panel will meet to review and make recommendations on the classification of three devices that are currently unclassified: semi-constrained toe joint prostheses, intracompartmental pressure monitors and intra-abdominal pressure monitoring devices.
Additional meetings on FDA's fall calendar include:
MDUFA reauthorization. On Friday, FDA announced a virtual public meeting on reauthorization of the Medical Device User Fee Amendments (MDUFA) for 2023 through 2027, which will take place from 9 a.m. to 2 p.m. on Oct. 27 after being delayed from the spring.
FDA is seeking comments on the current medical device user fee program and commitments the agency should propose for the next reauthorized program. The current legislative authority for the medical device user fee program expires on Sept. 30, 2022. New legislation is required for FDA to continue to collect user fees for the medical device program in future fiscal years.
Wilson-Cook's Flourish device. FDA's Pediatric Advisory Committee is set to meet Sept. 15 from 10 a.m. to 4:30 p.m. to discuss various drug products as well as Wilson-Cook Medical's Flourish pediatric esophageal atresia device, which received a humanitarian device exemption in 2017 to restore digestive tract function in children under 1 year old.
Patient-reported outcomes in device evaluation. FDA plans to conduct a workshop titled "Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation" on Sept. 30 from 10 a.m. to 4 p.m. to discuss the benefits and challenges of incorporating the patient voice in regulatory decision making. PRO tools include questionnaires, diaries and numeric rating scales used to collect information directly from the patient about their health status.
TransMedics PMA. A meeting of the Circulatory System Devices Panel has been rescheduled from this past April to Oct. 7 between 9 a.m. to 6 p.m. to virtually discuss and vote on the PMA application for Transmedics' portable organ care system for the resuscitation, preservation and assessment of donor hearts.
Artificial intelligence/machine learning. FDA's Patient Engagement Advisory Committee plans to meet virtually Oct. 22 from 10 a.m. to 5 p.m. to discuss artificial intelligence and machine learning in medical devices. Specific topics include composition of datasets, information shared with patients and patient trust in the technology.
Neovasc PMA. A meeting of the Circulatory System Devices Panel planned for Oct. 27 will review the PMA application for Neovasc's Reducer device for patients with refractory angina pectoris who do not respond to medical therapy and are not suited for coronary artery bypass grafting or percutaneous coronary intervention.
Orthopaedic device-related infections. FDA will host the first in an intended series of public workshops on Nov. 13 from 8 a.m. to 1 p.m. regarding orthopaedic device-related infections. The agency said planned discussion topics include the current science on technologies linked to infections, research gaps on infections in joint arthroplasty and orthopaedic trauma devices and potential new technologies that could impact public health in the fields of joint arthroplasty and trauma care.