On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021.
In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates that the FDA is continuing to spend substantial time on this endeavor. Stakeholders are strongly encouraged to provide comments.
Tools to analyze whether an activity is remanufacturing
Several portions of the guidance offer helpful tools to analyze the scope of an activity. The guidance flow chart, though it does not apply to software, is nonetheless a very useful mechanism to aid in determining if the device activity to be undertaken will be a “significant change to the intended use” such that the activity could be considered “remanufacturing”. The examples in the guidance appendices further help to clarify when an activity is “remanufacturing”.
FDA ‘encourages’ dissemination of specific instructions for device maintenance and repair
Section 502 of the Food Drug & Cosmetic Act (with certain limited exemptions not applicable here), requires that device labeling bear adequate directions for use. Hence, of particular importance is the guidance list of “servicing instructions” which the FDA encourages manufacturers to provide to facilitate routine maintenance and repair. These include:
A description of the key performance and safety specifications;
Critical technical or functional specifications, including: Physical dimensions;
Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength).
The recommended maintenance activities and schedule;
Recommended routine testing and acceptance criteria to confirm that the device remains within its performance and safety specifications;
A description of error codes, alerts, and alarm features on the device;
Precautions and warnings relevant to servicing the device; and
Version number and release date of software.
Guidance should confirm distribution of instructions for use is “mandatory”
While the above listing is indeed helpful, we hope the FDA confirms in the final Remanufacturing Guidance that the documentation to be supplied should not be limited to this listing. Rather in the interests of promoting and protecting the public health, we hope the guidance affirms that the documentation/labeling to be supplied be adequate to perform maintenance consistent with the OEM original equipment servicing requirements.
Perhaps a rule of thumb could be to also provide the device instructions, which are supplied by the OEM when submitting to the FDA a device for premarket approval. 21 C.F.R. 807.87 requires, in connection with a premarket notification submission, the FDA receive “proposed labels, labeling and advertisements sufficient to describe the device, its intended use and the directions for its use. Where applicable, photographs or engineering drawings should be supplied.” Is it really appropriate, as some suggest, these likely more detailed “instructions for use” be withheld under a “trade secret” designation? The trade secret designation is of small solace when a problem arises that requires immediate servicing activities.
The draft guidance also notes an additional concern for servicers who may not possess adequate instructions for use: “[u]nintentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications.”
Could a scenario arise where adequate instructions are withheld from distribution and thereafter a claim of remanufacturing is advanced? This situation might be alleviated if the final guidance confirms that distribution of the instructions for use is “mandatory” under existing law.
The recent executive order from the Biden Administration requires the heads of all federal agencies to consider using their authority to further the policies of promoting competition. Accordingly, a hospital’s right to have choices in the servicing of equipment could well be another reason for clarification in the guidance. Shouldn’t the paramount interests of patient safety confirm that hospital medical device owners and their designated servicers receive adequate instructions? Shouldn’t there be meaningful consequences outlined if these instructions are withheld from the hospital owners and their designated servicers?
About the author: Robert J. Kerwin is the general counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS).
This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/55575