Table 4. Change in Probability of Class I or Class II Recalls for the 35 176 Medical Devices That Received US Food and Drug Administration (FDA) 510(k) Clearance by the Characteristics and the Cause of Ongoing Recalls for the Predicate Medical Devicesa.
| Probability of class I or II recalls of 510(k) medical devices, percentage point change (95% CI)b | ||||||
|---|---|---|---|---|---|---|
| By mean age of predicate medical devices without adjustment for product type and manufacturer fixed effectsc | By newest and oldest age of predicate medical devices without adjustment for product type and manufacturer fixed effectsc | By age ≥10 y for predicate medical devices without adjustment for product type and manufacturer fixed effectsc | By mean age of predicate medical devices adjusted for product type and manufacturer fixed effectsc | By newest and oldest age of predicate medical devices adjusted for product type and manufacturer fixed effectsc | By age ≥10 y for predicate medical devices adjusted for product type and manufacturer fixed effectsc | |
| Characteristics | ||||||
| Mean age of predicate medical devices, y | –0.13 (–0.23 to –0.04) | –0.10 (–0.20 to –0.01) | ||||
| Age of newest predicate medical devices, y | –0.26 (–0.37 to –0.15) | –0.18 (–0.30 to –0.07) | ||||
| Age of oldest predicate medical devices, y | 0.07 (–0.03 to 0.16) | 0.04 (–0.06 to 0.14) | ||||
| ≥1 Predicate medical devices aged ≥10 y | 0.06 (–0.89 to 1.01) | 0.40 (–0.67 to 1.46) | ||||
| No. of predicate medical devices | 0.38 (0.14 to 0.61) | 0.25 (–0.02 to 0.52) | 0.37 (0.13 to 0.60) | 0.55 (0.34 to 0.77) | 0.47 (0.24 to 0.71) | 0.53 (0.31 to 0.74) |
| No. of unique nonmatching product typesd,e | –0.27 (–1.33 to 0.79) | –0.32 (–1.38 to 0.73) | –0.25 (–1.31 to 0.80) | –0.17 (–1.16 to 0.81) | –0.22 (–1.20 to 0.76) | –0.13 (–1.11 to 0.84) |
| No. of unique nonmatching medical specialtiese,f | 0.48 (–0.12 to 1.08) | 0.35 (–0.24 to 0.95) | 0.43 (–0.17 to 1.03) | –0.09 (–0.80 to 0.62) | –0.18 (–0.89 to 0.54) | –0.16 (–0.88 to 0.56) |
| No. of prior 510(k) clearances from manufacturer | 0.03 (0.01 to 0.04) | 0.03 (0.01 to 0.04) | 0.03 (0.01 to 0.04) | –0.01 (–0.02 to 0) | –0.01 (–0.02 to 0) | –0.01 (–0.02 to 0) |
| No. of prior 510(k) clearances from manufacturer for same product type | –0.03 (–0.10 to 0.04) | –0.03 (–0.10 to 0.04) | –0.02 (–0.09 to 0.05) | –0.08 (–0.14 to –0.02) | –0.08 (–0.14 to –0.02) | –0.07 (–0.14 to –0.01) |
| Ongoing recalls g | ||||||
| ≥1 Class I or class II recalls of predicate medical devices by causeh | ||||||
| Miscellaneous | 14.50 (10.85 to 18.14) | 14.45 (10.80 to 18.09) | 14.43 (10.79 to 18.06) | 5.17 (1.50 to 8.85) | 5.14 (1.46 to 8.81) | 5.11 (1.45 to 8.78) |
| Software | 16.67 (12.19 to 21.14) | 16.74 (12.28 to 21.20) | 16.79 (12.32 to 21.26) | 5.90 (1.95 to 9.84) | 5.92 (1.97 to 9.87) | 5.92 (1.98 to 9.86) |
| Device design or component | 9.99 (5.57 to 14.41) | 9.84 (5.39 to 14.28) | 9.96 (5.54 to 14.38) | –1.26 (–4.87 to 2.35) | –1.36 (–5.00 to 2.27) | –1.31 (–4.93 to 2.31) |
| Materials or composition | 9.78 (5.04 to 14.52) | 9.63 (4.89 to 14.38) | 9.69 (4.97 to 14.41) | 3.59 (–0.79 to 7.96) | 3.50 (–0.87 to 7.88) | 3.53 (–0.83 to 7.88) |
| Manufacturing environment | 3.69 (–1.11 to 8.49) | 3.62 (–1.19 to 8.44) | 3.65 (–1.15 to 8.45) | –3.41 (–8.01 to 1.19) | –3.42 (–8.03 to 1.19) | –3.40 (–7.98 to 1.19) |
| Labeling | 6.66 (1.29 to 12.02) | 6.57 (1.18 to 11.95) | 6.66 (1.29 to 12.04) | –0.01 (–5.08 to 5.07) | –0.03 (–5.11 to 5.06) | 0 (–5.09 to 5.09) |
| Packaging | 6.78 (–0.08 to 13.63) | 6.77 (–0.08 to 13.63) | 6.42 (–0.41 to 13.24) | 3.37 (–4.04 to 10.78) | 3.44 (–3.96 to 10.84) | 3.15 (–4.24 to 10.55) |
| Application | 9.05 (–17.61 to 35.70) | 8.69 (–18.08 to 35.46) | 8.96 (–17.81 to 35.72) | 12.06 (–9.90 to 34.02) | 11.81 (–10.24 to 33.86) | 11.86 (–10.11 to 33.82) |
The final sample of 35 176 devices represented 72.2% of the devices cleared by the FDA between 2003 and 2018.
Linear probability models were used to assess whether the applicant device would experience a class I or class II recall between its FDA regulatory clearance date and December 31, 2020, per unit change in the characteristics of the predicate medical devices. A class I recall indicates there is potential for serious patient harm or death. A class II recall indicates there is potential for temporary or reversible patient harm or a slight chance of serious patient harm or death. The models adjusted for listed predicate and manufacturer characteristics, year fixed effects, and product type and manufacturer fixed effects in columns 5-7. The SEs used in computing the 95% CIs were clustered at the manufacturer level.
The age of the predicate medical device was defined as the number of years between FDA clearance of the predicate device and FDA clearance of the applicant device. See definition for product type in footnote d. Variations on similar manufacturer names in the FDA database were standardized into a single manufacturer name (additional information appears in eAppendix 1 in Supplement 1).
Nonmatching product types refer to the number of unique product types of the predicate medical device that do not match the product types of the applicant device. The product types are FDA-assigned identifiers to describe the generic function of a medical device (additional information appears in the study sample subsection of the Methods section).
The data in these rows reflect dissimilarity between the applicant device and the predicate device.
Nonmatching medical specialties refer to the number of unique medical specialties of the predicate medical device that do not match the medical specialties of the applicant device. There are 19 FDA medical specialty review panels that are responsible for reviewing a medical device. The medical specialty review panels are assigned based on a medical device’s product type.
Investigation has not yet terminated (resolved) for the predicate device at the time of FDA clearance for the applicant device.
Manually assigned to categories based on the reason for the recall (eTable 3 in Supplement 1).