FDA Releases Draft Guidance on Voluntary Medical Device Recalls, Raising Concerns About Inconsistencies Between the Guidance and Current Regulations
UNITED STATES – According to an online article published by www.raps.org, the FDA has released a draft guidance regarding the process for initiating voluntary recalls of medical devices, raising concerns among many interested parties that specific terms within the draft guidance are inconsistent with existing federal regulations.
The United States Food and Drug Administration (FDA) often releases draft guidances to help with the interpretation of certain FDA rules and regulations. When the FDA releases such guidances, individuals and parties can submit comments that the FDA reviews and considers before implementing a final guidance.
The draft guidance at issue seeks to improve the efficiency and timeliness of voluntary recalls in accordance with specific FDA rules and regulations. Multiple interested parties submitted comments expressing concerns about a contradictory definition of the term “initiation of recall.” The parties assert that it is unclear, based on the language of the draft guidance, when a recall should be initiation, and that the FDA needs to clarify the matter.
The current regulations that apply to certain medical devices define “initiation of recall” in a way that differs from the definition shown in the recent draft guidance. Such a discrepancy can make it difficult for medical device manufacturers to understand and comply with all rules and regulations.
Another concern is that inconsistencies within the language of the regulations and the draft guidance regarding reasons for medical device recalls and whether a device poses a risk of harm to patients make it difficult to know whether a medical device should be recalled, and if so, for a good reason. Specifically, one issue is that a medical device may violate some regulations but not be considered harmful to patients while another medical device may not violate some regulations but be considered harmful to patients. Such a discrepancy, according to some concerned parties, needs clarification from the FDA.
Additionally, it is unclear, according to some concerned parties, whether the FDA intends for the draft guidance to supersede the existing regulation, even though rules and regulations are more authoritative than a guidance document.
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