I am reaching out to get feedback and on your thoughts regarding Reeces Law and obligations for medical devices:
The U.S. Consumer Product Safety Commission (CPSC) published two final rules in the U.S. Federal Register.
As a result, for products that incorporate button batteries or coin cell batteries, manufacturers and/or importers are required to provide a General Certificate of Conformity (GCC) for medical electrical devices, laboratory and measuring equipment and personal hygiene and health care appliances.
My question is: Are home use/lay user medical devices containing these batteries in scope of this legislation if they have applicable 510k clearance for a medical intended use and labelling contains appropriate labelling warnings and precautions? From what i can read and understand of the consumer requirements medical devices are not in scope?
Do the medical device regulations require manufacturers to adhere to consumer product legislation?
Interested to hear your thoughts.
In general, medical devices are not exempt from other legislation. There are often multiple rules that have to be followed for a particular product. Sometimes a rule will specifically exempt medical devices from its scope, for example if it might be unnecessary in that context, or excessively restrictive in that context, or duplicated.
Reese's Law does have an exemption for medical devices.
It applies to "consumer products containing button cell or coin batteries", with consumer products defined as "any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence" ... "but such term does not include-" ... "drugs, devices, or cosmetics (as such terms are defined in sections 201(g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g), (h), and (i)])"
Medical devices are already required to be safe, and I expect the risk assessment for every home-use device covers the things that can go wrong if a child is playing with it. Manufacturers are allowed to choose a method for keeping battery-containing devices safe in the presence of small children. They might use labeling and containment similar to that defined in Reese's Law per ANSI/UL 4200A. They might make the battery inaccessible as in the ASTM F963 standard for batteries in toys. They might choose a safer battery type. Or any other method that prevents that type of injury.
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