Reorganization of FDA’s CDRH to Impact Neurotech Vendors
by Jennifer French, senior editor
March 2019 issue
The much-anticipated reorganization of the FDA Center for Device and Radiological Health began implementation this month. The most significant change will be the realignment of offices around the total product lifecycle. The agency will now promote a team approach around key areas of the medical device industry. It is expected to “enhance communication” among the staff within CDRH and streamline “activities across the lifecycle from premarket review to postmarket surveillance,” according to the reorganization announcement.
Outgoing FDA commissioner Scott Gottlieb said, “We are exploring various new regulatory options to streamline timely implementation of postmarket mitigations.” In the same statement, Gottlieb applauded CDRH for approving a record number of devices including the first artificial pancreas and the first blood test to evaluate TBI.
One of the most impactful changes for the neurotech industry is the creation of the new “super office,” the Office of Product Evaluation and Quality. This will combine the offices of device evaluation, surveillance, and biometrics along with in vitro diagnostics and radiological health. Within this new office will be seven device specialty areas or offices of health technology. These include orthopedics, cardiovascular, reproductive, gastro-renal, urological, general hospital and human factors; and neurological and physical medicine. For the latter, Carlos Pena will remain as the office director.
One other potential impact to the neurotech industry is a new Office of Strategic Partnerships and Technology Innovation, under which will be digital health, health informatics, and innovation. It is yet to be seen where a potential new device like a bioelectronic medicine wearable would fall between this office and the super office. The offices of communication, management, and science and engineering laboratories will remain the same.
The implementation of this reorganization began on March 18 and is expected to conclude at the end of September. This effort will be led by CDRH director Jeff Shuren. In the meantime, the industry should anticipate some minor disruptions but the FDA communication team is open to assist with guidance. Theoretically, this restructuring will create a “one stop shop” for the medical device industry. Neurotech ventures will not likely feel an immediate impact, but it could help to streamline the regulatory review and compliance process in the near future.