FDA is seeking nominations of professionals to work on the advisory committees that help it review medical devices and some of the regulations covering them.
The request for nominations covers one committee that provides feedback on manufacturing regulations and a cluster of panels that assess different types of medical devices.
In total, FDA is seeking more than 40 people, mostly independent experts in specific fields, to start working on the panels immediately or later in 2019 and 2020.
Most of the people recruited by FDA will work on the group of panels that make up the Medical Devices Advisory Committee. FDA refers cases to the 18 panels that make up MDAC when it wants expert advice on how to respond to data on the safety and effectiveness of authorized and investigational devices.
In the case of investigational devices, FDA turns to panels for recommendations if the product is a novel, potentially impactful technology or if the data generated to support its authorization has big weaknesses, such as integrity issues or a questionable risk-benefit profile.
All but one of the 18 MDAC panels, which specialize in fields such as immunology and neurology, are set to get new members by the end of 2020. In many cases, FDA wants new experts to join the panels immediately. The only MDAC panel not covered by the request for nominations is focused on ear, nose and throat devices.
In its request, FDA provides details of the type of experts it wants for each panel, noting, for example, that neurosurgeons, neurologists, interventional neuroradiologists, psychiatrists and biostatisticians can join its neurological devices panel. Some of the requests are more specific, such as FDA’s call for people with experience of devices using artificial intelligence or machine learning to join its panel on hematology and pathology devices.
The other request for experts covers FDA’s Device Good Manufacturing Practice Advisory Committee. That body has a different remit than the MDAC panels. Rather than providing feedback on the safety and effectiveness of devices, DGMPAC makes recommendations about the "feasibility and reasonableness" of proposed regulations relating to good manufacturing practices. DGMPAC also reviews manufacturer requests for exemptions or variances from the rules.
FDA wants representatives of the general public, government and healthcare professionals to join DGMPAC. These four people will represent the interests of their groups as DGMPAC reviews cases.