Table 3. Characteristics of Predicate Lineages for Devices Subject to Class I Recalls.
| No. (%) | |
|---|---|
| Predicates subject to Class I recalls with predicate lineages | |
| Total No. | 64 |
| Devices authorized using predicatesa | 177 |
| Authorized devices per predicate, median (IQR) | 2 (1.5 to 3.5) |
| Time between predicate clearance and new device clearance, median (IQR), y | 4.7 (2.1 to 8.1) |
| Time between new device clearance and predicate Class I recall, median (IQR), y | 1.6 (−0.4 to 7.2) |
| Predicates recalled prior to new device clearance | 88 (49.7) |
| Preceding predicate recalls still open (nonterminated) when new device cleared, No. (subtotal %) | 57 (64.8) |
| Predicates subject to Class I recalls before new device clearance | 51 (28.8) |
| Preceding predicate Class I recalls still open (nonterminated) when new device cleared, No. (subtotal %) | 28 (54.9) |
| Index devices subject to Class I recalls with predicate lineagesb | |
| Total No. | 104 |
| Authorized using index devices as predicates, total No.c | 265 |
| Authorized devices per index device, median (IQR) | 2 (1 to 3) |
| Time between index device clearance and new device clearance, median (IQR), y | 4.2 (2.3 to 7.9) |
| Time between new device clearance and index device Class I recall, median (IQR), y | 2.8 (−0.4 to 7.7) |
| Index devices recalled before new device clearance | 134 (50.6) |
| Preceding index device recall still open (nonterminated) when new device cleared, No. (subtotal %) | 95 (70.9) |
| Index device subject to Class I recall before new device clearance | 76 (28.7) |
| Index device Class I recall still open (nonterminated) when new device cleared, No. (subtotal %) | 53 (69.7) |
| Index device authorizing devices later subject to any class recall | 63 (60.6) |
| Index device authorizing devices later subject to Class I recall | 50 (48.1) |
a
Refers to the cohort of 64 predicates subject to Class I recalls
b
Of the 156 index devices, 104 were documented in the regulatory intelligence platform as having been used as predicates for future device authorizations. These descendant relationships were subsequently validated using the Devices@FDA database.
c
Refers to the cohort of 104 index devices subject to Class I recalls.