The regulator put out the final guidance document to ensure companies are able to clearly distinguish a recall from a market withdrawal after the draft version sparked concern and confusion throughout the industry.
The agency's Center for Devices and Radiological Health put the finishing touches on a controversial guidance document on how to distinguish the recall of a device from a market withdrawal, issuing final guidance that makes many changes relative to a 2013 draft.
Medical device makers have historically struggled with determining what constitutes a recall. While scenarios involving medical device defects or failures are typically clear, other situations exist that pose uncertainty regarding whether the previous version needs to be recalled, such as the release of a new and improved version of an existing product.
The 2013 draft of the guidance had set off widespread concern throughout the industry, namely about creating paperwork burdens and new ammunition for product liability lawsuits when it proposed requiring the reporting of any enhancement aimed at reducing health risks. That requirement could conceivably have covered not only important changes to previously sold devices but also minor modifications to unsold products.
The document was also criticized for creating confusion by not defining certain terms like “initiated” in relation to a recall, “risk to health” and “minor violations.”
To address confusion related to circumstances under which a product must be recalled, the FDA issued a guidance document in its final form that provides increased specificity in its definitions and is intended to help manufacturers identify when they need to notify the FDA of recalls.
Some of the biggest changes relate to contested definitions, with the FDA clarifying terms such as “correction” and “removal,” and providing definitions for terms such as "routine servicing." The FDA also addedexamples describing hypothetical changes to devices and its position on whether those actions would likely constitute recalls or enhancements.
With “Distinguishing Medical Device Recalls from Medical Device Enhancements,” the FDA also eliminated a section of the draft guidance requiring an 806 report for enhancements, specifically stating that enhancements don’t necessitate the submission of an 806 report. The move will likely appease device makers that were alarmed with the FDA’s proposal and had questioned its authority under the Federal Food, Drug and Cosmetic Act for the reporting requirement.