Considerations for Medical Industry

The FDA’s framework raises more questions than it answers. Below are a few of the considerations the discussion paper does not address but will be important for industry. First, although the FDA says that it seeks to improve informed consent by adding information regarding the potential risk of hypersensitivity or immunologic responses, simply listing constituent materials may not achieve that purpose. Either manufacturers would be responsible for adding that risk information, which could impose an undue burden, or patients and doctors would be responsible for finding that information from other sources, which are not guaranteed to be reliable. Second, the discussion paper suggests that “toxicological risks” for constituent materials may need to be added to device labeling. But it does not specify how manufacturers should obtain that information, e.g., through their own testing already required by FDA regulations, through additional unspecified testing, from the manufacturers of constituent materials, or otherwise. Nor does it specify whether FDA will weigh in on whether a constituent material poses a toxicological risk, or whether or how manufacturers should distinguish between toxicological risks that may pose clinical risks versus those that have no or minimal clinical risk. Third, the proposed requirement to include trade names for constituent materials in device labeling may pose a unique burden on manufacturers. Setting aside the business issues and possible unintended consequences that this proposal may occasion, such as disruptions to the supply chain, FDA’s framework is far from clear. For example, if a raw material supplier changes due to supply chain or other issues, must the device labeling change each time the brand of constituent material changes? Must that labeling change be paired with additional information such as a Dear Customer letter to call attention to the change? Each additional obligation increases the burden on the manufacturer and, ultimately, may inhibit the manufacturer’s ability to deliver medical devices to doctors and patients in need. Fourth, the discussion paper leaves unstated whether the constituent materials list should identify the raw materials used to manufacture the device or the materials in the finished device. Because materials may change during the manufacturing process and because risk information may be different for raw materials versus materials that have gone through the manufacturing process, additional clarity on this point will be needed. Fifth, the discussion paper does not explain how device-related trade secrets and other proprietary information about device materials will remain protected. By comparison, in the cosmetics context FDA requires products to have a list of all ingredients and rarely grants trade secret exemptions, but “fragrance and flavor ingredients do not need to be listed individually on cosmetic labels, because they are the ingredients most likely to be ‘trade secrets.’”16 The discussion paper does not propose any trade secret exemption for medical devices or otherwise address this issue. Path Forward The discussion paper signals that medical device materials continues to be an area of interest for FDA, and one where we are likely to see additional regulatory scrutiny moving forward. Stakeholders should consider submitting feedback before the August 18, 2021 deadline, and continue to monitor whether this proposal develops into a draft guidance or otherwise requires changes to their device labeling.