An op-ed by Robert J. Kerwin
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, and now the circulation of a draft guidance indicates that the FDA is continuing to spend substantial time on this endeavor.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
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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.