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FY 2002 ODE Annual Report - Part 7 - Operational Summary - Section 2

Table 10. Original HDE Decision Cohort Performance
Table 11. HDE Supplement Decision Cohort Performance
Table 12. Original IDEs
Table 13. IDE Amendments
Table 14. IDE Supplements
Table 15. 510(k) Decision Cohort Performance
Table 16. 510(k) Receipt Cohort Performance


 Table 10.  Original HDE Decision Cohort Performance
FY98 – FY02

 

FY 98

FY 99

FY 00

FY 01

FY 02

 
Number Received

8

12

11

5

5

 
HDE Action            
  Filing Decisions            
    Filed

9

10

8

6

6

 
    Not Filed

1

1

4

1

1

 
    Othersa

1

1

0

0

0

 
Filing Decisions Subtotal

11

12

12

7

7

 
  Scientific Review Decisions            
    Major Deficiencies

0

6

7

7

6

 
    Minor Deficiencies

1

0

3

6

2

 
    Otherb

0

4

6

2

0

 
Scientific Review Decisions Subtotals

1

10

16

15

8

 
  Approval Decisions            
    Approvals

4

6

6

4

6

 
    Approvable

0

5

1

0

0

 
    Not Approvable

0

0

0

0

0

 
    Denials

0

0

0

0

0

 
Approved Decision Subtotal

4

11

7

4

6

 
  Other Final Decisionsc

2

4

1

4

2

 
Total HDE Actions

18

37

36

30

23

 
             
Filing to First Actiond            
  Number of First Actions

6

13

8

6

6

 
  Average Number of FDA Days

139

87

61

42

53

 
  Number of First Actions Within 75 Days

1

7

8

6

5

 
  Average Elapsed Time (Days) for Approvalse            
    FDA

152

113

112

143

175

 
    Non-FDA

0

50

104

100

127

 
    Total

152

163

216

243

302

 
             
Average Number of FDA Cycles from Receipt            
  to Final Actionf 1.2 1.2 1.3 1.9 2.1  
             
  Number under Review at End of Periodg            
    Activeh

3

2

2

1

1

 
    Active and Overdue

0

0

0

0

0

 
    On Holdi

1

8

8

6

3

 
    Total

4

10

10

7

4

 
a/ Includes final actions, such as withdrawal or conversion to another regulatory category, that occur prior to a filing decision being made.
b/ Includes actions that did not result in a final decision, such as GMP deficiency letter or an applicant-directed hold.
c/ Includes final actions other than approval or denial, such as withdrawal, abandonment warning letter or conversions to another regulatory category.
d/ 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.
e/ The average amount of time taken to obtain approval of an HDE from the filing date until final approval.
f/ 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.
g/ 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.
h/ The application is under review by FDA.
i/ FDA's review of the application is officially suspended pending receipt of additional information from the applicant.

 Table 11.  HDE Supplement Decision Cohort Performance
FY98 – FY02

 

FY98

FY99

FY00

FY01

FY02

 
             
Number Received

0

4

10

16

16

 
             
HDE Supplement Actions            
             
Scientific Review Decisions            
  Major Deficiencies

0

1

0

0

0

 
  Minor Deficiencies

0

0

0

0

0

 
  Othera

0

2

0

1

1

 
Scientific Review Decisions Subtotal

0

3

0

1

1

 
             
Approval Decisions            
  Approvals

0

3

10

11

13

 
  Approvable

0

1

0

0

6

 
  Not Approvable

0

0

1

1

6

 
  Denials

0

0

0

0

0

 
Approval Decision Subtotal

0

4

11

12

25

 
Other Final Decisionsb

0

0

0

1

1

 
Total HDE Actions

0

7

11

13

27

 
             
Filing to First Actionc            
  Number of First Actions

0

4

10

12

17

 
  Average Number of FDA Days

0

57

44

52

53

 
  Number of First Actions within 75 Days

0

4

10

8

16

 
             
Average Elapsed Time (Days) for Approvalsd            
  FDA

0

70

43

46

60

 
  Non-FDA

0

24

33

0

14

 
Total

0

94

76

46

74

 
             
Average Number of FDA Cycles from            
  Receipt to Final Actione

0.0

1.3

1.0

1.0

1.3

 
             
Number Under Review at End of Periodf            
  Activeg

0

0

0

4

4

 
  (Active and Overdue)

0

0

0

0

0

 
  On Holdh

0

1

1

1

4

 
Total

0

1

1

5

8

 
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 which are 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 12.  Original IDEs
FY 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
             
Number Received

322

304

311

284

312

 
             
Number of Decisions            
  Approved

201

176

213

208

209

 
  Not Approved

82

82

66

53

75

 
  Othera

42

47

41

23

23

 
Total

325

305

320

284

307

 
             
Percent (%) of Approvals Made during First            
  Review Cycleb

71

68

76

80

74

 
             
Average FDA Review Time (days)

27

27

28

28

28

 
             
Percent (%) of Decisions Made within 30 Days

100

99

99

100

99

 
             
Number under Review at End of Periodc

29

28

19

18

22

 
             
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.

 Table 13.  IDE Amendments
FY 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
             
Amendments Receiveda

226

275

240

206

252

 
             
Decisions on Amendments            
  Approved

94

97

107

73

86

 
  Not Approved

36

42

34

39

55

 
  Otherb

95

129

110

95

110

 
Total

225

268

251

207

251

 
             
Average FDA Review Time (days)

19

18

19

18

18

 
             
Percent (%) of Decisions Made within 30 Days

100

100

100

99

100

 
             
Average Approval Time (days)            
For IDEs with Amendments            
  FDA Time

55

57

70

59

68

 
  Non-FDA Time

35

88

66

82

67

 
Total Timec

90

145

136

141

135

 
             
Number of Amendments per Approved IDE

1.4

1.6

2.3

1.7

2.2

 
             
Amendments under Review at End of Periodd

13

19

9

8

7

 
             
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.

 Table 14.  IDE Supplements
FY 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
             
Number Received

4,277

4,127

4,388

4,811

4,724

 
             
Number of Decisions

4,209

4,224

4,335

4,803

4,711

 
             
Average FDA Review Time (days)

21

20

20

21

20

 
             
Percent (%) of Decisions Made within 30 Days

100

100

100

100

100

 
             
Number under Review at End of Perioda

284

187

239

247

260

 
             
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 15.  510(k) Decision Cohort Performance
FY 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
             
Number Originals Received

4,623

4,458

4,202

4,248

4,320

 
Number of Decisions            
  Substantially Equivalent

3,824

3,652

3,567

3,428

3,667

 
  Not Substantially Equivalent

65

66

52

46

69

 
  Othera

1,340

875

778

676

640

 
Total

5,229

4,593

4,397

4,150

4,376

 
             
Percent (%) Not Substantially Equivalentb

1.7

1.8

1.4

1.3

1.8

 
             
Average Review Time (Days)            
  FDA Timec

89

80

77

75

79

 
  Total Timed

114

102

102

96

100

 
             
Median Review Time (Days)            
  FDA Timec

81

71

68

68

70

 
  Total Timed

83

76

72

72

74

 
             
Percent (%) of Decisions made within 90 Days, based on          
  FDA Timee

97

99

100

100

100

 
  Total Timed

59

66

66

69

69

 
             
Number under Review at End of Periodf            
  Activeg

1,057

943

850

934

935

 
  (Active and Overdue)

0

0

0

0

0

 
  On Holdh

487

461

370

382

337

 
Total 1,544 1,404 1,220 1,316 1,272  
a/ Includes final administrative actions that did not result in a substantially equivalent/not substantially equivalent decision because of 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 action.
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 additonal 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 16.  510(k) Receipt Cohort Performance *
FY 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
Number of 510(k)s Receiveda            
  Traditional

4,528

3,985

3,471

3,370

2,467

 
  Special

80

396

584

710

562

 
  Abbreviated

21

85

149

174

136

 
Total Receipts

4,629

4,466

4,204

4,254

3,165

 
             
Actions on 510(k)s            
  Substantially Equivalent

3,573

3,605

3,423

3,545

2,336

 
  Not Substantially Equivalent (%)b

70(1.9)

63(1.7)

44(1.3)

58(1.6)

35(1.5)

 
  Otherc

986

798

737

602

354

 
Total Actions

4,629

4,466

4,204

4,205

2,725

 
             
Average Cumulative Days for 510(k) Decisions            
Excludes Withdrawals and Deletes            
  FDA Time from Receipt to Final Decisiond

82

81

75

78

65

 
  Total Time from Receipt to Final Decisione

104

104

95

96

73

 
All Decisions Including Withdrawals and Deletes            
  FDA Time from Receipt to Final Decisiond

81

79

74

76

64

 
  Total Time from Receipt to Final Decisione

118

114

104

102

76

 
             
Number of Decisions (%) with 90 Days, Based on:            
  FDA Days from Receipt to First Action

4,612(100)

4,453(100)

4,198(100)

4,245(100)

3,158(100)

 
  FDA Cumulative Days from Receipt to            
    Final Decisions

3,529(76)

3,372(76)

3,370(80)

3,258(77)

2,375(75)

 
  Total Cumulative Days from Receipt to            
    Final Decisionse

3,025(65)

2,938(66)

2,916(69)

2,889(68)

2,206(70)

 
Average Number of FDA Cycles            
  from Receipt to Final Action

1.4

1.4

1.4

1.4

1.2

 
             
Percentile FDA (Total) Days from Receipt to Final Action  
  25th

47(51)

41(45)

35(41)

31(35)

32(35)

 
  50th (Median)

75(83)

71(78)

65(73)

70(77)

71(77)

 
  75th

90(149)

90(147)

89(126)

90(145)

90(138)

 
  90th

160(256)

160(263)

153(238)

164(237)

N/A(N/A)

 
             
Number under Review as of 9/30/01            
  Active

0

0

0

22

199

 
  Active and Overdue

0

0

0

0

0

 
  On Hold

0

0

0

27

241

 
Total

0

0

0

49

440

 
Summary of 510(k) Receipt Cohort            
  Substantially Equivalent

3,573

3,605

3,423

3,545

2,336

 
  Not Substantially Equivalent

70

63

44

58

35

 
  Other

986

798

737

602

354

 
  Under Review

0

0

0

22

199

 
  On Hold

0

0

0

27

241

 
Total

4,629

4,466

4,204

4,254

3,165

 
*/ For each fiscal year, September 30, 2002 was used as the cutoff date. The FY02 cohort represents only receipts through June 30, 2002 (first nine months of the fiscal year).
a/ Includes Third Party 510(k)s: FY98 = 18; FY99 = 32; FY00 = 47; FY01 = 70; FY02 = 95
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.