Studies published in JAMA detailed how stronger safeguards are needed to prevent problematic predicate selection of medical devices, and also demonstrated significant associations between submission characteristics for 510(k) medical devices and medical device recalls.
Medical devices that cite predicate products that are subject to recalls in their 510(k) filings are more likely to be recalled, according to studies published in the Journal of the American Medical Association.
A pair of studies tackled the topic from different angles. One study found devices that reference predicate products with three or more ongoing recalls are significantly more likely to be recalled themselves. The other study showed predicates subject to Class I recalls increased the risk of the new device being subject to the same regulatory action by 6.4 times.
The authors of the second study see their research as evidence that “stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety.”
Read the full article at MedTech Dive.