The FDA issued draft guidance July 7 to exempt 19 types of radiology device accessories from premarket notification requirements. Among the devices (see list below) include film cassettes, film processors and digitizers. The exemptions, part of draft guidance issued Thursday, also include 11 types of vitro diagnostic devices including those commonly used for and blood tests, alcohol breath tests, and blood clotting protein tests.
In the meantime, the FDA will, at its discretion, not be enforcing premarket notification requirements for these devices, “provided that they do not exceed the limitations on exemption specified in the device classification regulations,” the agency said.
"The safety and effectiveness of these devices have been well demonstrated over the years," said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "By addressing the risk level of these devices, the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers, while making sure the public has safe and effective devices."
The agency said it intends to reduce the pre-market regulatory burden on additional in vitro diagnostic and radiology device types in the future.
The FDA is seeking further comment on the draft guidance from manufacturing, clinical and patient communities. The draft guidance is open for comment for 90 days.
Radiology Devices Proposed for Exemption
Devices classified under 21 CFR 892.1610, Diagnostic x-ray beam-limiting device, which includes the following product codes:
• IZS - Aperature, Radiographic
• IZW - Collimator, Automatic, Radiographic
• IZX - Collimator, Manual, Radiographic
• IZT -Cone, Radiographic
• KPW - Device, Beam Limiting, X-Ray, Diagnostic
Devices classified under 21 CFR 892.1670, Spot-film device, which includes the following product code:
• IXL - Device, Spot-Film
Devices classified under 21 CFR 892.1850, Radiographic film cassette, which includes the following product code:
• IXA - Cassette, Radiographic Film
Devices classified under 21 CFR 892.1860, Radiographic film/cassette changer, which includes the following product code:
• KPX - Changer, Radiographic Film/Cassette
Devices classified under 21 CFR 892.1870, Radiographic film/cassette changer programmer, which includes the following product code:
• IZP - Programmer, Changer, Film/Cassette, Radiographic
Devices classified under 21 CFR 892.1900, Automatic radiographic film processor, which includes the following product codes:
• EGT - Controller, Temperature, Radiographic
• EGW - Dryer, Film, Radiographic
• IXX - Processor, Cine film
• IXW - Processor, Radiographic-Film, Automatic
• EGY - Processor, Radiographic-Film, Automatic, Dental
Devices classified under 21 CFR 892.2030, Medical image digitizer, which includes the following product codes:
• LMA - Digitizer, Image, Radiological
• NFH - Digitizer, Images, Ophthalmic
Devices classified under 21 CFR 892.2040, Medical image hardcopy device, which includes the following product codes:
• LMC - Camera, Multi Format, Radiological
• NFI - Device, Hardcopy, Images, Ophthalmic
Devices classified under 21 CFR 892.1820 Pneumoencephalographic chair, which includes the following product codes:
• HBK - Chair, Pneumocephalographic