A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.
The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH received and granted in 2017 and 2018, with the exception of one 2009 submission that was not granted until 2012.
The six down-classifications are intended to reduce the burden associated with the premarket application (PMA) process. The five class II final orders set via the requests also expand device eligibility for the 510(k) premarket review pathway—considered to be a less-burdensome approach compared to PMAs for devices automatically placed into class III.
The de novo classification requests came from various companies including Allergan, Wilson-Cook Medical, Pacer Therapeutics, Scion NeuroStim and FRESCA Medical and MolecuLight. The only new class I device type—the wound autofluorescence imaging device
—stems from MolecuLight’s request. “Devices within this type are exempt from the premarket notification requirements under section 510(k),” subject to certain exemption limitations, CDRH noted.
The remaining five classifications separately establish new special controls, ranging from software verification to biocompatibility, on each of the new class II device types through amendments to the FD&C Act
. Four of these classifications are for device types intended for prescription use only, which are exempted from the adequate directions for use requirement.
Prescription devices now classified into class II (special controls) include hemostatic device for intraluminal gastrointestinal use
, the intranasal electrostimulation device for dry-eye symptoms
, the positive airway pressure delivery system
and the thermal vestibular for headache
It took agency review staff more than three years to issue an order to Pacer Therapeutics for classifying the light-based energy source device for topical application
into class II. A review clock can be impacted by several different factors, such as intended use. Early interactions in the application process with CDRH staff are encouraged for more timely decisions on requests, FDA said.
The final orders are also part of broader
, agency-wide efforts to reduce regulatory burden on manufacturers. CDRH has continued to tweak its de novo program—created about 20 years ago to set an expedited mechanism to reclassify devices based on their risk profiles—to achieve greater efficiencies. A proposed
regulation to codify the review process is set for FY 2019.
The agenda revealed
Wednesday on new rulemakings indicates the agency is also working on a rule to revamp the classification process in that it would begin using “administrative orders to announce or to change the classification of devices, instead of taking action by regulation.”