USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products

Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products", "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices"and "Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions".

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products:

A hearing aid is “any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing” (21 CFR 800.30(b) and 21 CFR 801.422(b)). This definition encompasses both air-conduction and bone-conduction devices in a variety of styles (e.g., behind-the-ear, in-the-canal, body worn).

This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs).

A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

This guidance is intended to update and provide clarity on the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff to promote consistent application of the concepts in this guidance.

This guidance also incorporates concepts and recommendations from FDA's guidances entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device," "Deciding When to Submit a 510(k) for a Software Change to an Existing Device," and "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],"

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

The labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the hydrogen peroxide-based contact lens care products (HPCPs) in conjunction with a user’s prescribed contact lenses.

These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.