US FDA Finalizes 510(k) Exemptions for Some Class I and II Medical Devices
The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.
The final guidance states that until the FDA issues a final rule regarding such exemptions, the regulator will not enforce 510(k) compliance for qualifying devices. Examples of Class I, II and unclassified devices targeted for exemption include the following:
- Anesthesiology devices: powered algesimeters (BSI), nitrogen dioxide analyzers (MRQ), portable air compressors (BTI)
- Cardiovascular devices: lung sound monitors (OCR), oscillometers (DRZ), trocars (DRC)
- Dental devices: pulp testers (EAT), dental irrigating syringes (EIB), fluid-filled teething rings (KKO)
- Ear, nose and throat devices: inserted hearing detectors (EWD), electroglottographs (KLX), master hearing aids (KHL)
- Gastroenterology-urology devices: hemorrhoid cushions (LRL), colostomy rods (EZP), esophageal ligators (MND)
- General and plastic surgery devices: talking first aid kits (OVR), ophthalmic patient drapes (HMT), incandescent surgical lamps (GBC)
- General hospital and personal use devices: medical support stockings (DWL), conductive patient restraints (BRT), ultraviolet medical water purifiers (KMG)
- Neurological devices: ataxiagraphs (GWW), ventricular cannulae (HCD), shunt system implantation instruments (GYK)
- Obstetrical and gynecological devices: proceptive fertility diagnostic devices (LHD), cervical drains (HFL), liquid crystal thermographic systems (LHM)
- Ophthalmic devices: photorefractors (MMF), AC-powered euthyscopes (HMK), battery-powered corneal burrs (HOG)
- Physical medicine devices: spine curvature monitors (LZW), powered reflex hammers (IKO), paraffin baths (IMC)
Again, the FDA has selected these devices for exemption from 510(k) premarket notification requirements because the agency considers these products well understood in terms of safety and effectiveness. Other regulatory requirements, however, will still have to be met in order for these devices to be sold legally in the US. Applicable requirements include 21 CFR Part 807 on registration and listing; 21 CFR Part 820 on FDA Quality System Regulations; 21 CFR Part 801 on labeling; and 21 CFR Part 803 on reporting.