FDA Issues Draft on Recalls and Enhancements

In February 2013, the FDA issued draft guidance entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” which provides distinction between a recall and an enhancement, and the related ramifications of each.  The importance of identifying the difference stands to highlight the timing and nature of regulatory responsibility and prevent delays in public notification when a defect or failure of a device occurs.

The draft guidance provides clarity on how to identify a recall, noting that a change to a device already on the market due to failure to meet specifications, failure to perform as intended or failure to be of a quality purported or represented, as well as false or misleading labeling, would constitute a medical device recall. 

There is further clarity on regulatory reporting requirements for recalls and product enhancements.  Recalls must be reported when there is a health risk, defined in the draft guidance as reasonable probability the product will cause serious health consequences or death, may cause temporary or medically reversible adverse health consequences, or may lead to an outcome where the probability of serious adverse health consequences is remote. The FDA recommended that companies conduct a health hazard evaluation taking into account numerous factors such as the history of disease or injuries from the product, assessment of hazard to population segments, and the degree and likelihood of the hazard. 

Comments on the draft guidance were due by May 23, 2013, and the draft is already facing scrutiny from device manufacturer Boston Scientific and The Advanced Medical Technology Association (AdvaMed), which represents device makers.  Boston Scientific believes there were inconsistencies in the regulatory language and that definitions used in the guidance were inconsistent with one another. Specifically, Boston Scientific pointed to the introduction of 'product enhancement' in the definitions of 'correction' and 'removal.'  AdvaMed, meanwhile, believes the FDA should pull the draft guidance and re-release a draft in the future, pointing to inconsistencies as well. 


David Katz is a Senior Audit Manager providing domestic and international accounting, auditing and business consulting services to public and private clients in a variety of industries.

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