The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued two final orders on Wednesday, classifying the insulin therapy adjustment and the meprobamate test system device types into class II (special controls).
The classifications have been applicable since
April for the meprobamate detection assay and since
June for the insulin adjustment device, following the de novo classification requests FDA granted to Lin-Zhi International and DreaMed Diabetes in 2017. The new orders finalized the pathways for both device types to undergo premarket reviews via the 510(k) pathway.
CDRH issues classifications to ease regulatory burden with the goal of increasing patient access to devices because, without them, any new device for which there is no predicate to demonstrate substantial equivalence via a 510(k) submission is automatically classified into class III and are subject to PMA documentation requirements.
CDRH has issued
of final orders this year, including
last week, to down-classify a wide range of devices, with the latest batch being the third one this month. The actual impact these actions are having at the manufacturer level remains to be seen, though FDA’s parent agency was recently touted
as being the top “cabinet agency in terms of regulatory accomplishments for Fiscal Year 2018, reducing the burden of its regulations in present-value terms by $12.5 billion.”
The final orders also codify the new classifications of the device types and establish special controls that amend the FD&C Act
under authority delegated to the agency based on collections of information subject to review by the Office of Management and Budget in the areas of premarket approval, 510(k) submissions, quality system regulations and device labeling.
“An insulin therapy adjustment device
is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus” whereas a “meprobamate test system
is a device intended to measure meprobamate in human specimens,” according to the identifications established by the final orders.
CDRH identified three special controls for each of the two new device types, specifying the types of information regarding the development phase that manufacturers should include as part of 510(k) submissions for a device to avoid an automatic class III classification. The special controls for both devices, which involve conducting design verification and validation and designing labels, are aimed at mitigating the identified risks to patient health that may result from device use.
The remaining special control relates to use indications. The meprobamate test system “must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions” and the insulin therapy adjustment device “must not be intended for use in implementing automated insulin dosing,” according to the final orders.