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# Draft Remanufacturing Guidance Falls Short: Mintz Analysis
- URL: https://www.fdaweb.com/draft-remanufacturing-guidance-falls-short-mintz-analysis/
- Published: 2021-07-21T12:00:00.000Z
- Updated: 2026-09-14T17:07:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149756

Mintz attorneys say an FDA draft remanufacturing guidance issued 7/24 may be a step in the right direction to help entities identify when they are performing remanufacturing activities and thus subject to agency regulation, but does not provide a clear process for such determinations. The analysis says a flowchart included in the guidance leads to only two “vague” conclusions — likely remanufacturing or likely not remanufacturing — which are inadequate to guide third-party servicing entities regarding their regulatory obligations.

“The flowchart does not result in a determination that an activity is or is not remanufacturing and provides ample leeway for entities to simply ignore the result or fabricate a justification for why an activity is not remanufacturing,” the law firm says. “Furthermore, the flowchart does not demonstrate the formal investigation and risk-based determination process that should be used to analyze the regulatory implications of each activity involving a legally marketed device but simply asks the ultimate question, ‘Is there a significant change to device performance or safety specifications?’ which is the core requirement for an activity to be remanufacturing.”

The analysis says the draft is “merely a long-winded version of the definition of ‘remanufacturing’ with some fairly general examples attached, when what is actually needed is an interpretation of the definition that can serve as a basic engineering change control process template for entities that have not implemented quality management systems. We look forward to seeing how FDA modifies the draft guidance in response to public comments.”