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FY 2001 ODE Annual Report - Part 6 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
FY97 — FY01

 

FY 97

FY 98

FY 99

FY 00

FY 01

 
Number Received

4

8

12

11

5

 
HDE Action      
  Filing Decisions      
    Filed

2

9

10

8

6

 
    Not Filed

0

1

1

4

1

 
    Othersa

0

1

1

0

0

 
Filing Decisions Subtotal

2

11

12

12

7

 
  Scientific Review Decisions      
    Major Deficiencies

0

0

6

7

7

 
    Minor Deficiencies

1

1

0

3

6

 
    Otherb

0

0

4

6

2

 
Scientific Review Decisions Subtotals

1

1

10

16

15

 
  Approval Decisions      
    Approvals

2

4

6

6

4

 
    Approvable

0

0

5

1

0

 
    Not Approvable

0

0

0

0

0

 
    Denials

0

0

0

0

0

 
Approved Decision Subtotal

2

4

11

7

4

 
  Other Final Decisionsc

0

2

4

1

4

 
Total HDE Actions

5

18

37

36

30

 
       
Filing to First Actiond      
  Number of First Actions

2

6

13

8

6

 
  Average Number of FDA Days

68

139

87

61

42

 
  Number of First Actions Within 75 Days

1

1

7

8

6

 
  Average Elapsed Time (Days) for Approvalsc      
    FDA

108

152

113

112

143

 
    Non-FDA

12

0

50

104

100

 
    Total

120

152

163

216

243

 
       
Average Number of FDA Cycles from Receipt 1.0

1.2

1.2

1.3

1.9

 
  to Final Actionf      
       
  Number under Review at End of Period      
    Active

2

3

2

2

1

 
    Active and Overdue

0

0

0

0

0

 
    On Hold

0

1

8

8

6

 
    Total

2

4

10

10

7

 
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 unsolicted 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 intial 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
FY97 — FY01

 

FY97

FY98

FY99

FY00

FY01

 
       
Number Received

0

0

4

10

16

 
       
HDE Supplement Actions      
       
Scientific Review Decisions      
  Major Deficiencies

0

0

1

0

0

 
  Minor Deficiencies

0

0

0

0

0

 
  Othera

0

0

2

0

1

 
Scientific Review Decisions Subtotal

0

0

3

0

1

 
       
Approval Decisions      
  Approvals

0

0

3

10

11

 
  Approvable

0

0

1

0

0

 
  Not Approvable

0

0

0

1

1

 
  Denials

0

0

0

0

0

 
Approval Decision Subtotal

0

0

4

11

12

 
Other Final Decisionsb

0

0

0

0

1

 
Total HDE Actions

0

0

7

11

13

 
       
Filing to First Actionc      
  Number of First Actions

0

0

4

10

12

 
  Average Number of FDA Days

0

0

57

44

52

 
  Number of First Actions within 75 Days

0

0

4

10

8

 
       
Average Elapsed Time (Days) for Approvalsd      
  FDA

0

0

70

43

46

 
  Non-FDA

0

0

24

33

0

 
Total

0

0

94

76

46

 
       
Average Number of FDA Cycles from      
  Receipt to Final Actione

0.0

0.0

1.3

1.0

1.0

 
       
Number Under Review at End of Periodf      
  Activeg

0

0

0

0

4

 
  (Active and Overdue)

0

0

0

0

0

 
  On Holdh

0

0

1

1

1

 
Total

0

0

1

1

5

 
a/Includes actons 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 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 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
       
Number Received

297

322

304

311

284

 
       
Number of Decisions      
  Approved

172

201

176

213

208

 
  Not Approved

79

82

82

66

53

 
  Othera

21

42

47

41

23

 
Total

272

325

305

320

284

 
       
Percent (%) of Approvals Made during First      
  Review Cycleb

69

71

68

76

80

 
       
Average FDA Review Time (days)

29

27

27

28

28

 
       
Percent (%) of Decisions Made within 30 Days

100

100

99

99

100

 
       
Number under Review at End of Periodc

32

29

28

19

18

 
       
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 lessapprovals) because of deletions and conversions which are not reflected in the table.

Table 13. IDE Amendments
FY 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
       
Amendments Receiveda

223

226

275

240

206

 
       
Decisions on Amendments      
  Approved

101

94

97

107

73

 
  Not Approved

25

36

42

34

39

 
  Otherb

94

95

129

110

95

 
Total

220

225

268

251

207

 
       
Average FDA Review Time (days)

18

19

18

19

18

 
       
Percent (%) of Decisions Made within 30 Days

100

100

100

100

99

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

61

55

57

70

59

 
  Non-FDA Time

84

35

88

66

82

 
Total Timec

145

90

145

136

141

 
       
Number of Amendments per Approved IDE

1.8

1.4

1.6

2.3

1.7

 
       
Amendments under Review at End of Periodd

12

13

19

9

8

 
       
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 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
       
Number Received

3,776

4,277

4,127

4,388

4,811

 
       
Number of Decisions

3,777

4,209

4,224

4,335

4,803

 
       
Average FDA Review Time (days)

21

21

20

20

21

 
       
Percent (%) OF Decisions Made within 30 Days

100

100

100

100

100

 
       
Number under Review at End of Perioda

216

284

187

239

247

 
       
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 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
       
Number Originals Received

5,049

4,623

4,458

4,202

4,248

 
Number of Decisions      
  Substantially Equivalent

4,405

3,824

3,652

3,567

3,428

 
  Not Substantially Equivalent

57

65

66

52

46

 
  Othera

693

1,340

875

778

676

 
Total

5,155

5,229

4,593

4,397

4,150

 
       
Percent (%) Not Substantially Equivalentb

1.3

1.7

1.8

1.4

1.3

 
       
Average Review Time (Days)      
  FDA Timec

97

89

80

77

75

 
  Total Timed

130

114

102

102

96

 
       
Median Review Time (Days)      
  FDA Timec

81

81

71

68

68

 
  Total Timed

85

83

76

72

72

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

95

97

99

100

100

 
  Total Timed

58

59

66

66

69

 
       
Number under Review at End of Periodf      
  Activeg

1,287

1,057

943

850

934

 
  (Active and Overdue)

0

0

0

0

0

 
  On Holdh

865

487

461

370

382

 
Total2,1521,5441,4041,2201,316 
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 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

Number of 510(k)s Receiveda     
  Traditional

5,059

4,528

3,985

3,471

2,392

  Special

0

80

396

584

522

  Abbreviated

0

21

85

149

137

Total Receipts

5,059

4,629

4,466

4,204

3,051

      
Actions on 510(k)s     
  Substantially Equivalent

4,150

3,573

3,603

3,397

2,246

  Not Substantially Equivalent (%)b

53(1.3)

70(1.9)

63(1.7)

40(1.2)

27(1.2)

  Otherc

856

986

798

718

340

Total Actions

5,059

4,629

4,464

4,155

2,613

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

91

82

81

73

65

  Total Time from Receipt to Final Decisione

116

104

104

91

74

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

89

81

79

72

64

  Total Time from Receipt to Final Decisione

134

118

114

99

75

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

4,968(98)

4,612(100)

4,453(100)

4,197(100)

3,047(100)

  FDA Cumulative Days from Receipt to     
    Final Decisions

3,558(70)

3,529(76)

3,372(76)

3,364(80)

2,264(74)

  Total Cumulative Days from Receipt to     
    Final Decisionse

3,025(60)

3,025(65)

2,938(66)

2,917(69)

2,074(68)

Average Number of FDA Cycles     
  from Receipt to Final Action

1.5

1.4

1.4

1.4

1.3

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

51(57)

47(51)

41(45)

35(41)

32(36)

  50th (Median)

80(86)

75(83)

71(78)

65(73)

71(77)

  75th

106(175)

90(149)

90(147)

89(126)

96(145)

  90th

172(312)

160(256)

160(263)

155(238)

N/A(N/A)

      
Number under Review as of 9/30/01     
  Active

0

0

1

17

169

  Active and Overdue

0

0

0

0

0

  On Hold

0

0

1

32

269

Total

0

0

2

49

438

Summary of 510(k) Receipt Cohort     
  Substantially Equivalent

4,150

3,573

3,603

3,397

2,246

  Not Substantially Equivalent

53

70

63

40

27

  Other

856

986

798

718

340

  Under Review

0

0

1

17

169

  On Hold

0

0

1

32

269

Total

5,059

4,629

4,466

4,204

3,051

*/For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through June 30, 2001 (first nine months of the fiscal year).
a/Includes Third Party 510(k)s: FY97 = 14; FY98 = 18; FY99 = 32; FY00 = 47; FY01 = 70
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, delted due to lack of response 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.