Table 2

Characteristics of preamendment medical devices reviewed under the 515 Program Initiative

Total, N (%)
(n=26)
Downclassified, N (%)
(n=10)
Split-reclassified, N (%)
(n=6)
Maintained, N (%)
(n=10)
Purpose of use
 Diagnostic1 (4)0 (0)0 (0)1 (100)
 Therapeutic25 (96)10 (40)6 (24)9 (36)
Therapeutic area
 Cardiovascular12 (46)3 (25)3 (25)6 (50)
 Dental2 (8)2 (100)0 (0)0 (0)
 Gastroenterology urology2 (8)1 (50)1 (50)0 (0)
 General and plastic surgery1 (4)1 (100)0 (0)0 (0)
 Neurology2 (8)0 (0)2 (100)0 (0)
 Obstetrics/gynaecology1 (4)0 (0)0 (0)1 (100)
 Orthopaedic3 (12)1 (33)0 (0)2 (67)
 Physical medicine2 (8)2 (100)0 (0)0 (0)
 Radiology1 (4)0 (0)0 (0)1 (100)
Implanted
 Yes9 (35)4 (44)0 (0)5 (56)
 No17 (65)6 (35)6 (35)5 (29)
Life-sustaining
 Yes3 (12)2 (67)0 (0)1 (33)
 No23 (88)8 (35)6 (26)9 (39)
Subject to 522 Postmarket Surveillance Studies Program as stated in final rule/order
 Yes2 (8)0 (0)0 (0)2 (100)
 No24 (92)10 (42)6 (25)8 (33)
Recalls issued before reclassification decision*
 Class I8 (31)2 (25)2 (25)4 (50)
 Class II18 (69)7 (39)5 (28)6 (33)
Advisory committee recommendation
 Agreed with final classification25 (96)9 (36)6 (24)10 (40)
 Disagreed with final classification1 (4)1 (100)0 (0)0 (0)
  • *Class I and II recalls were not mutually exclusive.