ARTICLE SUMMARY:
FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.
FDA added five product types to its list of unclassified devices that can skip 510(k) submissions while FDA takes steps to formally exempt them. The agency made the move in a guidance document it has been updating for about the past 10 years as a mechanism to streamline market access for lower-risk devices without companies having to wait for the time-consuming classification process to play out. The five added product types include a device to measure body posture, a urine test for monitoring tuberculosis treatment adherence, a motion sickness device, a nail prosthesis, and cups for eye wash solution (see list below).
Unclassified Devices FDA Intends to Exempt from Premarket Notification Requirements
Ear, Nose, and Throat Devices
- EWD – Protector, Hearing (Insert)
- EWE – Protector, Hearing (Circumaural)
- LEZ – Aids, Speech Training for the Hearing Impaired (AC-Powered and
- Patient-Contact)
- LFA – Aids, Speech Training for the Hearing Impaired (Battery-Operated or
- Non-Patient)
Gastroenterology-Urology Devices
- LRL – Cushion, Hemorrhoid
General and Plastic Surgical Devices
- LKB – Pad, Alcohol, Device Disinfectant
- MQZ – Prosthesis, Nail
Obstetrical and Gynecological Devices
- LHD – Device, Fertility Diagnostic, Proceptive
Physical Medicine Devices
- LDK – Device, Sensing, Optical Contour
- LZW – Monitor, Spine Curvature
Neurological Devices
- MVV – Device, Acupressure
Toxicology Devices
- MIG – Strip, Test Isoniazid
Ophthalmic Devices
- LXQ – Cup, Eye
Continue reading Pathways’ Picks here.