Regulatory Open Forum

 View Only
  • 1.  Reeses Law applicability to medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 09-Feb-2024 09:12
    This message was posted by a user wishing to remain anonymous

    HI all

    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.

    • The Commission voted and adopted ANSI/UL 4200A-2023, the Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries, as a safety standard for performance and labeling requirements meeting 16 CFR 1263, Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries, to establish alignment with the provisions of Reese`s Law. This rule will go into effect on March 19, 2024.
    • The Commission also included the criteria outlined in Section 1263.4, addressing the labeling requirements for button cell and coin battery packaging, which will have a separate enforcement date of Sept. 21, 2024.

    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.



  • 2.  RE: Reeses Law applicability to medical devices

    Posted 10-Feb-2024 08:17

    Hi Anon

    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.

    https://www.ecfr.gov/current/title-16/chapter-II/subchapter-B/part-1263

    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.



    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------