Consumer medical devices (CMD) are sold over-the-counter (OTC) at non-specialty retail locations including drug stores, grocery stores, convenience stores, and online. They have established safety profiles and are for use by consumers in non-clinical environments. Generally, no training is necessary to use a CMD. Manufacturers of CMDs rely on labeling, design, and consumer familiarity to ensure safe and effective use. Most CMDs are not subject to FDA’s premarket review requirements.
California A.B. 818, a bill requiring nonwoven disposable wipes to be labeled clearly and conspicuously with the phrase “Do Not Flush”, has passed both legislative chambers and awaits final concurrence in the Assembly.
A stakeholder advisory committee charged with making recommendations to the Washington legislature regarding the establishment of the state’s new extended producer responsibility for packaging law (E2SSB 5022) held their first meeting on Tuesday. The bill, which initially applied only to beverage containers, was expanded during the legislative session to include more product categories, but CHPA worked to secure an exemption for FDA approved over-the-counter medications, dietary supplements, and medical devices.