Product Liability Update

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

Jul 21, 2015

Daniel S. Wittenberg,

Partner

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket notification requirements. The objective behind this guidance was expressed during the re-authorization process of the Medical Device User Fee Act (MDUFA) in 2012. At that time, the FDA stated that identifying low-risk medical devices to exempt from premarket notification requirements was an important process improvement the agency was committed to completing. This is also a continuation of the goals set forth in the 510(k) Working Group committee report of 2010, wherein the FDA noted that it is working hard to improve predictability, increase transparency and raise the standard of 510(k) submissions, demonstrating the agency’ commitment to reducing regulatory burdens where practical, without compromising patient safety.

Until the publication of a final rule or order exempting these devices from 510(k), the FDA does not intend to enforce compliance with 510(k) requirements for these devices. As such, the FDA does not expect manufacturers to submit a 510(k) for these devices during this time period. It is important to note, however, that although a 510(k) submission will not be required before marketing these devices, Good Manufacturing Practice (including Design Controls), compliance with consensus standards, and medical device reporting will still be required. Likewise, manufacturers of these 510(k) exempt devices will still be subject to FDA inspections.

In producing this guidance, the FDA identified 120 devices that it believed are sufficiently well understood that further regulatory review is unnecessary to ensure their safety and effectiveness before they reach the market.

The following is a list of the devices the FDA intends to exempt:

Anesthesiology Devices

BSI – Powered Algesimeter
MRQ – Analyzer, Nitrogen Dioxide
KLK – Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LPP – Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
JAX – Pneumotachometer
CCO – Bed, Rocking, Breathing Assist
BTI – Compressor, Air, Portable

Cardiovascular Devices

DRC – Trocar
OCR – Lung Sound Monitor
DRZ – Oscillometer
MNW – Analyzer, Body Composition with the following labeling: Not to diagnose or treat any medical condition.
EAT – Tester, Pulp
EHR – Pad, Denture, Over The Counter
EHS – Cushion, Denture, Over The Counter
EBP – Reliner, Denture, Over The Counter
ELM – Denture, Plastic, Teeth
EKO – Denture Preformed (Partially Prefabricated Denture)
ELS – Splint, Endodontic Stabilizing
EGI – Parallelometer
EIB – Syringe, Irrigating (Dental)
KKO – Ring, Teething, Fluid-Filled

Ear, Nose & 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 NonPatient)
KLX – Electroglottograph
ETW – Calibrator, Hearing Aid / Earphone And Analysis System
EPF – Hearing Aid, Group And Auditory Trainer
LZI – Device, Assistive Listening
KHL – Hearing Aid, Master
ETC – Mold, Middle-ear

Gastroenterology – Urology Devices