FDA Draft Guidance on Voluntary Recalls Draws Concerns of Inconsistency

Regulatory NewsRegulatory News | 28 June 2019 |  By 

US Food and Drug Administration (FDA) draft guidance on voluntary recalls or product corrections should ensure consistency with current regulations, stakeholders said in recently submitted feedback.
The draft guidance seeks to improve the efficiency and timeliness of voluntary recalls under 21 CFR Part 7 Subpart C, with recommendations on preparations and procedures. Comments submitted to FDA argue consistency is needed across the draft guidance, Part 7 and 21 CFR 806.10. FDA should harmonize terms in regulations and regulatory guidances, commenters ask.
For devices that are subject to Part 806, AdvaMed vice president of technology and regulatory affairs Zachary Rothstein said FDA needs to clarify the issue of when a recall is initiated. The definition of the term “initiation of a recall” in the draft guidance and the definition the agency offered in the preamble to Part 806 “provide conflicting interpretations as to which applies in the context of medical devices and particularly for the purposes of Part 806,” Rothstein argued.
“While we agree that a guidance cannot negate a regulation, it is not clear whether FDA intends the draft guidance to supersede interpretations within the preamble to Part 806,” said Rothstein.
A comment from the International Society for Pharmaceutical Engineering (ISPE) echoed AdvaMed’s requests. “FDA appears to be creating a new term, ‘initiation of a recall’ that is not defined in 21 CFR Part 7, and that may cause confusion because there are many steps that a firm takes after it has decided to conduct a recall,” ISPE wrote in commenting on the draft.
The Bringing Real-world Insight for Device Governance and Evaluation (BRIDGE) Coalition argued the “apparent inconsistencies between Part 7 and Part 806 need to be resolved.” It cited 806.10 in noting that “a device can pose a risk to health without being violative and vice versa.”
AdvaMed and the BRIDGE Coalition requested set timeframes for FDA to respond to product inquiries and classify recalls. AdvaMed member companies “believe a five-day response period is appropriate due to the generally time-sensitive nature of a recall.” The BRIDGE Coalition suggested, “FDA classify recalls within no more than 10 days after notification by the firm.”
On a recommendation under general preparations, Canada-based generic drugmaker Apotex requested that FDA clarify the metrics it recommends when assessing appropriate recall plans and corrective actions.


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