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FY 2000 ODE Annual Report - Part 5 – Operational Summary - Section 2

Table 10. HDE Supplement Decision Cohort Performance FY97 – FY00
Table 11. Original IDEs FY 96 - FY 00
Table 12. IDE AmendmentsFY 96 - FY 00
Table 13. IDE Supplements FY 96 - FY 00
Table 14. 510(k) Decision Cohort Performance FY 96 - FY 00
Table 15. 510(k) Receipt Cohort Performance FY 96 - FY 00

Table 10. HDE Supplement Decision Cohort Performance
FY97 – FY00

 

FY 97

FY 98

FY 99

FY 00


Number Received


0


0


4


10

HDE Supplement Actions        
Scientific Review Decisions        
  Major Deficiencies

0

0

1

0

  Minor Deficiencies

0

0

0

0

  Othera

0

0

2

0

    Scientific Review Decisions Subtotal

0

0

3

0

         
Approval Decisions        
  Approvals

0

0

3

10

  Approvable

0

0

1

0

  Not Approvable

0

0

0

1

  Denials

0

0

0

0

    Approval Decision Subtotal

0

0

4

11


Other Final Decisionsb

0

0

0

  0

Total HDE Actions

0

0

7

11

         
Filing to First Actionc        
  Number of First Actions

0

0

4

10

  Average Number of FDA Days

0

0

57

44

  Number of First Actions Within 75 Days

0

0

4

10

         
Average Elapsed Time (Days) for Approvalsd        
  FDA

0

0

70

43

  Non-FDA

0

0

24

33

  Total

0

0

94

76


Average Number of FDA Cycles from Receipt
  to Final Actione



0



0



1.3



1.0

         
Number under Review at End of Periodf        
  Activeg

0

0

0

0

  Active and overdue

0

0

0

0

  On holdh

0

0

1

1

  Total

0

0

1

1

_________________
a/ Includes actions that did not result in a final decision, such as GMP deficiency letter or an applicant-directed hold.
b/ Includes final actions other than approval or denial, such as withdrawal or conversion to another regulatory category.
c/ First actions may include major and minor deficiency decisions; approvable, not approvable, approval and denial decisions; receipt of an unsolicited major amendment; and other final actions, such as withdrawal or conversion to another regulatory category.
d/ The average amount of time taken to obtain approval of an HDE Supplement from the filing date until final approval.
e/ A cycle is counted as the initial submission and each resetting of FDA’s review clock, such as a response to a non-filing decision or the submission of a major amendment.
f/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions not reflected in the table.
g/ The application is under review by FDA.
h/ FDA’s review of the application is officially suspended pending receipt of additional information from the applicant.

Table 11. Original IDEs
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Number Received

253

297

322

304

311
Number of Decisions          
  Approved 171 172 201 176 213
  Not approved 63 79 82 82 66
  Othera   26   21   42   47   41
  Total 260 272 325 305 320
           
Percent (%) of Approvals Made during First Review Cycleb 73 69 71 68 76
           
Average FDA Review Time (days) 28 29 27 27 28
           
Percent (%) of Decisions Made
  within 30 Days

99d

100

100

99

99
           
Number under Review at End of Periodc 8 32 29 28 19
           
Number Overdue at End of Period 0 0 0 0 0
           
____________________
a/ Includes deletions, withdrawals, and other administrative actions not resulting in an approval/disapproval decision.
b/ Based on "approved" and "not approved" decisions only.
c/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.
d/ In October 1995, ODE moved its offices from Piccard Drive to Corporate Boulevard in Rockville, Maryland. ODE accepted premarketing submissions during the 14-day moving period but added 2 weeks to the due dates of IDEs. This 2-week delay is reflected in the percent of decisions made within the 30 days for original IDEs and amendments. This policy was announced in two notices in the Federal Register of October 14, 1994 (pg. 52170) and November 29, 1994 (pg. 60092).

Table 12. IDE Amendments
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Amendments Receiveda    

219

223

226

275

240
           
Decisions on Amendments          
  Approved 98 101 94 97 107
  Not approved 29 25 36 42 34
  Otherb   91   94   95 129 110
  Total 218 220 225 268 251
           
Average FDA Review Time (days) 18 18 19 18 19
           
Percent (%) of Decisions Made within 30 Days 98e 100 100 100 100
           
Average Approval Time (days) for IDEs with Amendments          
  FDA time 53 61 55 57 70
  Non-FDA time   78   84   35   88   66
  Total timec 131 145 90 145 136
           
Number of Amendments per Approved IDE 1.4 1.8 1.4 1.6 2.3
           
Amendments under Review at End of Periodd 9 12 13 19 9
           
Amendments Overdue at End of Period 0 0 0 0 0
           
______________________
a/ Submissions received after the original IDE and prior to approval of the IDE application.
b/ Includes actions that did not result in an approval/disapproval decision, such as withdrawal of the IDE or the amendment by the sponsor, and other administrative actions, e.g., acknowledgement letters concerning the submission of information that did not require independent approval/disapproval and other administrative information, such as a change of address.
c/ The average IDE approval time represents the total time it has taken, on average, for an original IDE that was initially disapproved to be approved after the submission of amendments to correct deficiencies. The time being measured here covers the period from the date the original IDE was received to the date of final approval of an IDE amendment.
d/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.
e/ In October 1995, ODE moved its offices from Piccard Drive to Corporate Boulevard in Rockville, Maryland. ODE accepted premarket submissions during the 14-day moving period but added 2 weeks to the due dates of IDEs. This 2-week delay is reflected in the percent of decisions made within the 30 days for original IDEs and amendments. This policy was announced in two notices in the Federal Register of October 14, 1994 (pg. 52170) and November 29, 1994 (pg. 60092).

Table 13. IDE Supplements
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00

           
Number Received 3,189 3,776 4,277 4,127 4,388

Number of Decisions

3,121

3,777

4,209

4,224

4,335
Average FDA Review Time (days)
21

21

21

20

20

Percent (%) of Decisions Made within 30 Days
 
99

100

100

100

100

Number under Review at End of Perioda

148

216

284

187

239

Number Overdue at End of Period

0

0

0

0

0
           
______________________
a/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.

Table 14. 510(k) Decision Cohort Performance
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00

           
Number Originals Received 5,297 5,049 4,623 4,458 4,202
Number of Decisions          
  Substantially equivalent 4,501 4,405 3,824 3,652 3,567
  Not substantially equivalent 64 57 65 66 52
  Othera    998    693 1,340    875    778
  Total 5,563 5,155 5,229 4,593 4,397
Percent(%) not substantially          
  Equivalentb 1.4 1.3 1.7 1.8 1.4
Average Review Time (days)          
  FDA timec     110 97 89 80 77
  Total timed      145 130 114 102 102
Median Review Time (days)          
  FDA timec      85 81 81 71 68
  Total timed      88 85 83 76 72
Percent (%) of Decisions made
within 90 Days, based on
         
  FDA timee 80 95 97 99 100
  Total timed  50 58 59 66 66
Number under Review at End of Periodf          
  Activeg  1,408 1,287 1,057 943 850
  (Active and overdue) 0 0 0 0 0
  On holdh       821    865    487    461    370
  Total     2,229 2,152 1,544 1,404 1,220
           
_______________________
a/ Includes final administrative actions that did not result in a substantially equivalent/not substantially equivalent decision because the 510(k) or device/product was: withdrawn by the applicant, deleted due to lack of response, a duplicate, not a device, a transitional device, regulated by CBER, a general purpose article, exempted by regulation, and other miscellaneous actions.
b/ Based on "substantially equivalent" and "not substantially equivalent" decisions only.
c/ FDA time includes all increments of time FDA reviewed a 510(k), so long as the 510(k) document number did not change; changes in 510(k) document numbers occur rarely.
d/ Includes all time from receipt to final decision, i.e., does not exclude time a submission is on hold pending receipt of additional information.
e/ Considers whether FDA review time remained within 90 days, with FDA’s review clock being reset to zero whenever additional information was received (in accordance with 21 CFR 807.87(l)).
f/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less decisions) because of deletions and conversions which are not reflected in the table.
g/ FDA responsible for processing notification.
h/ FDA’s processing of notification officially suspended pending receipt of additional information from the submitter.

Table 15. 510(k) Receipt Cohort Performance*
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Number of 510(k)s Receiveda
                   
  Traditional 5,318   5,059   4,528   3,985   2,598  
  Special

0

 

0

  80   396  

456

 
  Abbreviated

      0

 

      0

       21        85  

   104

 
  Total Receipts

5,318

 

5,059

  4,629   4,466  

3,158

 
                     
Actions on 510(k)s                    
  Substantially Equivalent 4302   4150   3569   3579   2,333  
  Not Substantially
  Equivalent(%)b

57(1.3)

53(1.3)

68(1.9)

60(1.7)

24(1.0)

  Otherc    959     856     984      777      399  
Total Actions 5,318   5,059   4,621   4,416   2,756  
                     
Average Cumulative Days for 510(k) Decisions
Excludes Withdrawals and Deletes
  FDA Time from Receipt
    to Final  Decisiond

93
 
91
 
82
 
79
 
61
 
  Total Time from Receipt to
    Final Decisione

120
 
116
 
103
 
100
 
73
 
All Decisions Including
  Withdrawals and Deletes
                   
  FDA Time from Receipt to
    Final Decisiond

91
 
89
 
81
 
78
 
60
 
  Total Time from Receipt to
    Final Decisione

150
 
134
 
116
 
109
 
75
 
                     
Number of Decisions (%) within 90 Days,
  Based on:
  FDA Days from Receipt to
    First Action

4,998

(94)

4,968

(98)

4,612

(100)

4,454

(100)

3,150

(100)
  FDA Cumulative Days
    from Receipt to
                   
  Final Decision 3,472 (65) 3,558 (70) 3,530 (76) 3,367 (75) 2,452 (78)
  Total Cumulative Days
    from Receipt to
                   
  Final Decisione 2,901 (55) 3,025 (60) 3,025 (65) 2,938 (66) 2,214 (70)
                     
Average Number of FDA
  Cycles from Receipt to
   Final Action
 
1.5
 
1.5
 
1.4
 
1.4
 
1.3
                     
Percentile FDA (Total) Days from
Receipt to Final Action
  25th 51 (59) 51 (57) 47 (51) 41 (45) 34 (41)
  50th (Median) 80 (88) 80 (86) 75 (83) 71 (78) 64 (71)
  75th 115 (188) 106 (175) 90 (149) 90 (147) 90 (123)
  90th 173 (332) 172 (312) 160 (256) 162 (265) N/A (N/A)
                     
Number under review as
  of 9/30/00
                   
  Active 0   0   0   16   168  
  Active and Overdue 0   0   0   0   0  
  On hold 0   0   8   34   234  
  Total 0   0   8   50   402  
                     
Summary of 510(k) Receipt
  Cohort
                   
  Substantially Equivalent 4,302   4,150   3,569   3,579   2,333  
  Not Substantially Equivalent 57   53   68   60   24  
  Other 959   836   984   777   399  
  Under Review 0   0   0   16   168  
  On Hold        0          0          8        34     234  
  Total     5,318   5,059   4,629   4,466   3,158  
                     
  _________________________
*/ For each fiscal year, September 30, 2000 was used as the cutoff date. The FY00 cohort represents only receipts through June 30, 2000 (first nine months of the fiscal year).
a/ IncludesThird Party 510(k)s: FY97 = 14; FY98 = 18; FY99 = 32; FY00 = 30.
b/ Based on "substantially equivalent" and "not substantially equivalent" decisions only.
c/ Includes final administrative actions that did not result in a substantially equivalent/not substantially equivalent decision because the 510(k) or device/product was: withdrawn by the applicant, deleted due to lack of response, a duplicate, not a device, a transitional device, regulated by CBER, a general purpose article, exempted by regulation, and other miscellaneous actions.
d/ FDA time includes all increments of time FDA reviewed a 510(k), so long as the 510(k) document number did not change; changes in 510(k) document numbers occur rarely.
e/ Includes all time from receipt to final decision, i.e., does not exclude time a submission is on hold pending receipt of additional information.