Background: In the US, the majority of Class I medical device recalls—FDA’s most serious designation, indicating high probability of adverse health consequences or death—are attributed to devices cleared under the 510(k) pathway. The role of predicates, which are previously authorized devices used to clear new devices under 510(k), in Class I recalls has not been systematically studied. We sought to determine whether 510(k) devices subject to Class I recalls used predicates that had a previous history of recalls, and to assess whether recalled devices were used as predicates in future device authorizations.

Methods: In this cross-sectional study, all 510(k) devices subject to Class I recalls between January 2020 through December 2021 (“index devices”) were identified from the FDA’s annual recall listing. Information about predicate devices was extracted from index device decision memos in the Devices@FDA database. Devices authorized using index devices as predicates (“descendants”) were identified using a commercially available database. Devices were characterized by their regulatory history (medical specialty, product code, special designations, use of clinical evidence) and recall history (date of recall relative to index device recall or clearance, FDA classification of recall severity).

Results: Between 2020-21, 75 devices were subject to Class I recalls, with each recall affecting nearly ten thousand devices. Of these devices, 31 (41.3%) had prior recalls, including 13 (41.9%) with Class I recalls. These 75 devices had 109 unique predicates, of which 62 (56.9%) had prior recalls, including 43 (69.4%) with at least one Class I recall. Recalls for 36 predicates (30.3%) preceded the predicate’s use to support clearance of the index device, and recalls for 51 predicates (42.9%) preceded the index device’s Class I recall. Fifty-two (69.3%) index devices were predicates for subsequent device authorizations. Of the 94 unique descendants identified, 49 (52.1%) had recalls, including 39 (79.6%) with at least one Class I recall.

Conclusion: Many 510(k) devices subject to Class I recalls were authorized using predicates with a known history of safety concerns and were used to clear additional devices that were later recalled. Stronger safeguards for the 510(k) pathway are needed to prevent such problematic predicate selection.

Predicate Lineages and Medical Device Recalls in the 510(k) Pathway

Public Health and Health Policy | Other

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