RG - Obligations for Medical Device Companies under California Proposition 65

Question Posed:

Is it mandatory for medical device companies to label their products with Proposition 65 warnings? If so, why?

Answer Provided:

Medical devices are within scope of California Proposition 65 and are required to provide a 'clear and reasonable warning' on products that contain any of the substances over the applicable safe harbor level and where a risk of exposure exists.  California authorities are trying to quickly define safe harbor levels (no significant risk levels) for substances that may be contained within medical devices to limit the need for warnings if the device can be shown to be below those listed levels.  Lack of safe harbor levels for a substance means that the applicable level is zero and the product probably needs to include a warning.

It is hard to say how many medical companies are complying and why they are complying, but likely the possibility for lawsuits and the costs associated with them is the primary reason.  Others have possibly been part of a lawsuit and are following the terms of the settlement/decision and implementing warnings for other products to avoid further actions.

Note: In 1993, the Office of Environmental Health Hazard Assessment (OEHHA), who took over as designated lead agency for implementation of the Act, recommended repeal of section 12713 (Exposure to Foods, Drugs, Cosmetics, and Medical Devices) of TITLE 22 CALIFORNIA CODE OF REGULATIONS DIVISION 2.  Section 12713 allowed for use of State and Federal regulations substance restriction numbers as compliance with Proposition 65 in absence of significant risk levels for listed substances. It was often misinterpreted to mean that compliance with the State and Federal regulations meant exemption from Proposition 65. OEHHA recommended repeal of section 12713 because it provides little protection in the absence of a federal numeric regulatory level firmly based upon scientific data.

https://oehha.ca.gov/media/downloads/crnr/12713repealfsoroctober1993.pdf (reason 7 pages 30-33)

There is some dispute with the requirement of compliance with Proposition 65 by medical device companies.  One such group, Advanced Medical Technology Association (AdvaMed), has created a comment to the updated clear and reasonable warnings section 6 of the Act. Within the comment letter, they define several reasons why they believe medical devices should not be in scope including: Federal preemption, knowing a substance is contained in their product, exposure levels, and FDA requirements meeting the needs.  While this letter defines their concerns with the requirement to comply with Prop 65, it does not exempt medical devices from the requirement.

https://oehha.ca.gov/media/downloads/proposition-65/crnr/comments/advmedtechcomments012516.pdf

Reference: https://oehha.ca.gov/media/downloads/crnr/12713repealfsoroctober1993.pdf

**Article contents valid as of 2017-09-08

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