FDA updates guidance on unclassified devices

FDA has updated a 2015 guidance, saying it intends to exempt certain unclassified medical devices from premarket notification requirements.

Devices eligible for exemption include:

• Insert and circumaural hearing protectors.
• Speech-training aids for the hearing impaired, both AC-powered with patient contact and battery-powered, with no patient contact.
• Hemorrhoid cushions.
• Alcohol pads for disinfecting devices.
• Vibration threshold measurement and temperature discrimination test devices, except for those that provide an interpretation or a clinical implication of the measurement.
• Proceptive fertility diagnostic devices.
• Spine curvature monitors.

FDA puts medical devices into three classes, increasing in regulatory control from Class I to Class III.  Device classification depends upon the product’s intended use, indications for use, the risk to the patient, and finally, the risk to the user. FDA reviews device applications in one of two primary processes, the premarket notification 510(k) clearance and the more stringent premarket approval (PMA).

In general, most Class I devices are exempt from the 510(k), while most Class II devices require 510(k), and most Class III devices require a PMA.  The 510(k) is a premarket submission to the FDA that demonstrates that the new device to be marketed in the U.S. is “substantially equivalent” to a predicate device already being legally marketed in the U.S. and that doesn’t need a PMA.

FDA agreed in 2012 to identify low-risk medical devices to exempt from premarket notification. After the 21st Century Cures Act gave the agency the authority to periodically exempt class II and class I devices, it has done so for several of them.

The updated guidance can be found here.