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FY 2001 ODE Annual Report - Part 6 Operational Summary - Section 1

Table 3. PMA/HDE/IDE/510(k) Submissions Received

Table 4. Original PMA Decision Cohort Performance

Table 5. Original PMA Receipt Cohort Performance

Table 6. PMA Supplement Decision Cohort Performance

Table 7. PMA Supplement Receipt Cohort Performance

Table 8. PMA Panel Track Supplement Receipt Cohort Performance

Table 9. HDE Submissions Received

 

[NOTE: Although accurate at the time of publication, the data in the following tables may change slightly in subsequent reports to reflect changes in the regulatory status of submissions or verification of data entry. There are also likely to be changes in the previous years' annual report numbers in tables representing receipt cohort data. For example, if an incoming PMA supplement is later converted to an original PMA, changes are made in the appropriate tables. Likewise, some data from earlier reporting periods may have been changed to reflect similar corrections in data entry. These adjustments are not likely to have a significant effect on conclusions based on these data. Percentages of actions are presented in some tables. They may not add up to 100% in all cases due to the rounding off of fractions.] Refer to Tables 1 (page 17) and 2 (page 18) for general summary of major submissions received and completed.

Table 3. PMA/HDE/IDE/510(k) Submissions Received
FY 97 - FY 01

TYPE OF SUBMISSION

NUMBER RECEIVED

 

FY97

FY98

FY99

FY00

FY01

 
Premarket Approval (PMAs)            
  Original Applications

66

47

60

67

70

 
  Amendments

829

710

767

978

753

 
  Supplements

409

513

552

545

641

 
  Amendments to Supplements

819

863

924

932

918

 
  Reports for Original Applications

435

431

406

419

492

 
  Reports for Supplements

2

0

0

0

0

 
  Master Files

130

94

25

44

36

 
PMA Subtotal

2,690

2,658

2,734

2,985

2,910

 
Humanitarian Device Exemptions (HDEs)            
  Original Applications

4

8

12

11

5

 
  Amendments

10

32

55

56

62

 
  Supplements

0

0

4

10

16

 
  Amendments to Supplements

0

0

3

12

8

 
  Reports for Original Applications

0

0

6

9

24

 
  Reports for Supplements

0

0

0

0

0

 
HDE Subtotal

14

40

80

98

115

 
Investigational Device Exemptions (IDEs)            
  Original Applications

297

322

304

311

284

 
  Amendments

223

226

275

240

206

 
  Supplements

3,776

4,277

4,127

4,388

4,811

 
IDE Subtotal

4,296

4,825

4,706

4,939

5,301

 
Premarket Notification (510(k)s)            
  Original Notifications

5,049

4,623

4,458

4,202

4,248

 
  Supplements

2,785

2,023

1,872

1,742

1,579

 
  Amendments

4,433

3,692

2,962

2,953

2,620

 
510(k) Subtotal

12,267

10,338

9,292

8,897

8,447

 
PMA/HDE/IDE/510(k) Total

19,267

17,861

16,812

16,919

16,773

 


Table 4. Original PMA Decision Cohort Performance *
FY 97 - FY 01

 

FY 97

FY 98

FY 99

FY 00

FY 01

 
Number Received

70

55

72

67

70

 
PMA Action            
  Filing Decisions            
    Filed

58

51

65

64

62

 
    Not Filed

16

10

7

4

5

 
    Others

0

0

0

0

0

 
Filing Decisions Subtotal

74

61

72

68

67

 
  Scientific Review Decisions            
    Major Deficiencies

38

28

32

51

35

 
    Minor Deficiencies

5

10

4

11

4

 
    Othera

138

105

105

111

95

 
Scientific Review Decisions Subtotals

181

143

141

173

134

 
  Approval Decisions            
    Approvals

48

46

45

43

53

 
    Approvable

14

7

7

33

18

 
    Not Approvable

5

12

1

4

10

 
    Denials

0

0

0

0

0

 
Approved Decision Subtotal

67

65

53

80

81

 
Total PMA Actions

322

269

266

321

282

 
Average Review Time (Days) for Approvalsb            
    FDA

207

154

149

158

129

 
    Non-FDA

40

37

26

40

43

 
    Total

247

191

175

198

172

 
Average Elapsed Time (Days) for Approvalsc            
    FDA

375

265

280

244

257

 
    Non-FDA

122

108

100

119

154

 
    Total

497

373

380

363

411

 
Number under Review at End of Periodd            
    Active

44

29

49

35

45

 
    (Active and Overdue)

0

0

0

0

0

 
    On Hold

41

41

38

41

35

 
    Total 85 70 87 76 80  
*/ For FY 97, 98 and FY 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form content to PMAs but are exempt from the effectiveness requirements of PMAs. An approved HDE authorizes marketing of the humanitarian use device.
a/ Includes actions that did not result in an approval/denial decision, such as GMP deficiency letters prior to inspection, an applicant directed hold, reclassification of the device and conversion of the PMA to another regulatory category, or official correspondence concerning abandoment or withdrawal of the PMA, placing the PMA on hold, and other miscellaneous administrative actions.
b/ Average review times are calculated under the Premarket Approval of Medical Devices Regulation (21 CFR Part 814). Under this regulation, the review clock is reset upon FDA's receipt of a "major amendment" or a response to a "refuse to file" letter. Thus, average review time, unlike average elapsed time, excludes all review times that occurred prior to the latest resetting of the clock.
c/ The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elpased time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
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 not reflected in the table.
e/ FDA responsible for processing application.
f/. FDA processing of applications officially suspended pending receipt of additional information from the applicant

Table 5. Original PMA Receipt Cohort Performance *
FY 97 — FY 01

 

FY97

FY98

FY99

FY00

FY01

Original PMAs Received          
  PMAs

46

32

48

60

28

  Expedited PMAs

10

6

7

8

4

Total

56

38

55

68

32

           
Filing Decisionsa          
  Filed

56

38

55

68

32

  Not Filed

8

3

1

3

1

  Number (%) of Filing/Not Filing          
    Decisions within 45 Days

51(80)

30(73)

44(79)

54(76)

19(58)

  Average Days/Cycle

39

44

42

40

45

           
Final Actionsb          
  Approvals

45

26

51

38

10

  Denials

0

0

0

0

0

  Otherc

23

19

10

14

3

Total

68

45

61

52

13

           
Filing to First Action Excluding withdrawals, conversions, etc.d
  Number Received and Filed

56

38

55

68

32

  Number of First Actions

53

37

55

63

32

  Average FDA Days

147

134

145

132

133

  Median FDA Days

175

145

147

143

155

  Number (%) of First Actions with 180 Days

41(77)

32(87)

43(78)

63(100)

31(97)

           
Filing to First Action Including withdrawals, conversions, etc.e
  Number Received and Filed

56

38

55

68

32

  Number of First Actions

56

38

55

68

32

  Average FDA Days

146

134

145

133

133

  Median FDA Days

173

141

147

136

155

  Number (%) of First Actions with 180 Days

43(77)

33(87)

43(78)

68(100)

31(97)

           
Filing to Final Action Excluding withdrawals, conversions, etc.f
  Number Received and Filed

56

38

55

68

32

  Number of Final Actions

45

28

48

41

10

  Average FDA (Total) Elapsed Time

284(377)

238(348)

267(382)

210(293)

172(203)

  Median FDA (Total) Elapsed Time

237(297)

198(220)

251(344)

180(252)

177(188)

  Number (%) of Final Actions with 180 FDA Days

18(40)

12(43)

8(17)

21(51)

8(80)

Number (%) of Final Actions with 180 Total Days

15(33)

10(36)

5(10)

7(17)

5(50)

           
Filing to Final Action Including withdrawals, conversions, etc.g
  Number Received and Filed

56

38

55

68

32

  Number of Final Actions

55

36

52

54

10

  Average FDA (Total) Elapsed Time

269(413)

220(404)

268(392)

199(283)

172(203)

  Median FDA (Total) Elapsed Time

207(339)

180(288)

252(356)

180(248)

177(188)

  Number (%) of Final Actions with 180 FDA Days

23(42)

19(53)

9(17)

32(59)

8(80)

  Number (%) of Final Actions with 180 Total Days

17(31)

11(31)

5(10)

12(22)

5(50)

           
Average Number of FDA Cycles from Receipt to Final Action
  Including withdrawals, conversions, etc.b

1.8

1.7

2.0

1.5

1.2

           
Percentile FDA Days from Filing to First Actiond
  25th

118

99

115

99

104

  50th (Median)

175

145

147

143

155

  75th

182

175

179

177

177

  90th

217

192

227

180

179

           
Percentile FDA Days from Filing to First Actione
  25th

111

99

115

99

104

  50th (Median)

173

141

147

136

155

  75th

180

174

179

175

177

  90th

199

181

227

179

179

           
Percentile FDA (Total) Days from Filing to Final Actionf
  25th

175(178)

154(158)

254(252)

162(204)

163(177)

  50th (Median)

237(297)

198(220)

251(344)

180(252)

177(188)

  75th

416(545)

328(467)

322(491)

277(397)

179(212)

  90th

443(708)

392(888)

404(637)

319(482)

215(266)

           
Percentile FDA (Total) Days from Filing to Final Actiong
  25th

165(178)

141(168)

204(254)

151(195)

163(177)

  50th (Median)

207(339)

180(288)

252(356)

180(248)

177(188)

  75th

390(548)

285(645)

326(501)

249(381)

179(212)

  90th

443(766)

392(888)

392(637)

311(482)

215(266)

           
Number Pending as of 9/30/01          
  Active

0

0

0

3

10

  (Active and Overdue)

0

0

0

0

0

  On Holdh

1

3

3

12

15

Total

1

3

3

15

25

           
Summary of PMA Receipt Cohort          
  Approved

45

26

51

38

10

  Denied

0

0

0

0

0

  Withdrawn

11

10

4

10

3

  Other

12

9

6

4

0

  Under Review

0

0

0

3

10

  On Holdh

1

3

3

12

15

Total

69

48

64

67

38

*/ For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through March 31, 2001(first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
a/ The filing decision represents the count of applications with a filing date within the fiscal year as of the cutoff date. For example, a PMA that is considered complete at the time of submission would have a received date equal to the filed date. However, if the agendy refuses to file the PMA, it is considered incomplete and the filed date becomes the date of the amendment that makes the submission complete for filing. Therefore, it is possible that the submission may be received in one fiscal year but not be considered a filed PMA until a subsequent fiscal year. For the purpose of receipt cohort reporting, PMAs are considered "received" based on the filing date rather than the receipt date.
b/ The final action analyses include actions as of the cutoff date for PMAs received within the fiscal year.
c/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/ The first action analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure excludes PMAs with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure includes PMAs with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/
The final actions analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure excludes PMAs with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/ The final actions analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure includes PMAs with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

Table 6. PMA Supplement Decision Cohort Performance *
FY 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
             
Number Received

409

513

556

545

641

 
PMA Supplement Actions            
Panel Track Filing Decisionsa            
   Filed

15

7

17

14

10

 
   Not Filed

1

2

2

3

4

 
   Other

0

0

0

0

0

 
Filing Decision Subtotal

16

9

19

17

14

 
             
Scientific Review Decisions            
   Major Deficiencies

3

4

12

14

9

 
   Minor Deficiencies

1

2

0

1

0

 
   Otherb

128

62

60

83

78

 
Scientific Review Decisions Subtotal

132

68

72

98

87

 
             
Approval Decisions            
   Panel Track Approvalsc

4

5

11

12

10

 
   Nonpanel Track Approvals

397

416

426

462

432

 
   Approvable

49

47

25

100

100

 
   Not Approvable

76

63

62

58

52

 
Approval Decision Subtotal

526

531

524

632

594

 
             
Total PMA Supplement Actions

674

608

615

747

695

 
             
Average Review Time (Days) for Approvalsd            
   FDA

100

82

76

76

71

 
   Non-FDA

12

25

16

18

26

 
Total

112

107

92

94

97

 
             
Average Elapsed Time (Days) for Approvalse            
   FDA

120

109

92

95

78

 
   Non-FDA

23

43

26

27

32

 
Total

143

153

118

122

110

 
             
Number Under Review at End of Periodf            
   Activeg

110

139

158

98

152

 
   (Active and Overdue)

0

0

0

0

(6)

 
   On Holdh

80

57

70

84

94

 
Total

190

196

228

182

246

 
*/ For FY 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form content to PMAs but are exempt from the effectiveness requirements of PMAs. An approved HDE authorizes marketing of the humanitarian use device.
a/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/ Includes actions that did not result in an approval/denial decision, such as GMP letters prior to inspection, an applicant directed hold, reclassification of the device and conversion of the PMA supplement to another regulatory category, and official correspondence concerning the abandonment or withdrawal fo the supplement, the status of the supplement as a special (change being effected) or 30-day submission, and other miscellaneous administrative action.
c/ Panel track supplements are subject to the full administrative procedures normally associated with original PMAs, i.e., panel review, preparation of a summary of safety and effectiveness.
d/ Average review times are calculated under the Premarket Approval of Medical Devices Regulation (21 CFR Part 814). Under this regulation, the review clock is reset upon FDA's receipt of a "major amendment" or a response to a "refuse to file" letter. Thus, average review time, unlike average elapsed time, excludes all review times that occurred prior to the latest resetting of the clock.
e/ The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, furing which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time takento obtain approval of a PMA from its filing date until it receives final approval.
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/ FDA responsible for processing application.
h/ FDA processing of applications officially suspended pending receipt of additional information from the applicant

Table 7. PMA Supplement Receipt Cohort Performance *
FY 97 - FY 01

 

FY97

FY98

FY99

FY00

FY01

 
PMA Supplements Received            
  PMA Supplements

396

501

530

531

296

 
  Expedited PMA Supplements

2

1

2

3

0

 
  Panel Track PMA Supplements

6

9

11

10

6

 
  Expedited Panel Track PMA Supplements

1

0

4

1

0

 
Total

405

511

547

545

302

 
PMA Supplement Final Actionsb            
  Approvals

365

421

440

412

195

 
  Denials

0

0

0

0

0

 
  Otherc

34

81

85

97

59

 
             
Filing to First Action Excluding withdrawals, conversions, etc.a,d        
  Number Received and Filed

398

502

532

534

296

 
  Number of First Actions

389

482

513

517

281

 
  Average FDA Days

89

81

72

63

71

 
  Median FDA Days

71

57

36

37

48

 
  Number (%) of First Actions within 180 Days

346(89)

436(91)

464(91)

505(98)

270(96)

 
             
Filing First Action Including withdrawals, conversions, etc.e        
  Number Received and Filed

398

502

532

534

296

 
  Number of First Actions

398

500

532

532

291

 
  Average FDA Days

89

80

73

64

70

 
  Median FDA Days

68

47

35

35

44

 
  Number (%) of First Actions within 180 Days

353(89)

453(91)

481(90)

520(98)

280(96)

 
             
Filing to Final Action Excluding withdrawals, conversions, etc.f        
  Number Received and Filed

398

502

532

534

296

 
  Number of First Actions

363

455

486

485

243

 
  Average FDA (Total) Review Days

103(125)

91(115)

75(102)

65(81)

65(72)

 
  Median FDA (Total) Review Days

68(80)

46(65)

34(47)

32(40)

37(43)

 
  Number (%) of Final Actions within 180 Days

304(84)

376(83)

424(87)

461(95)

235(97)

 
  Number (%) of Final Actions within 180 Total Days

286(79)

352(77)

402(83)

437(90)

224(92)

 
             
Filing to Final Action Including withdrawals, conversions, etc.g        
  Number Received and Filed

398

502

532

534

296

 
  Number of First Actions

394

498

520

509

253

 
  Average FDA (Total) Review Days

106(141)

94(129)

79(115)

67(85)

64(71)

 
  Median FDA (Total) Review Days

72(93)

49(68)

36(51)

34(42)

37(43)

 
  Number (%) of Final Actions within 180 Days

323(82)

411(83)

452(87)

484(95)

254(97)

  Number (%) of Final Actions within 180 Total Days

296(75)

371(75)

420(81)

454(89)

234(93)

 
Average Number of FDA Cycles from Receipt to Final Action Including withdrawls, conversations, etc.b 1.1 1.1 1.1 1.1 1.0  
Percentile FDA Days from Filing to First Actiond            
  25th 29 22 19 21 26  
  50th (Median) 71 57 36 37 48  
  75th 162 169 147 113 127  
  90th 182 183 189 176 180  
Percentile FDA Days from Filing to First Actione            
  25th 29 22 19 20 26  
  50th (Median) 68 47 35 35 44  
  75th 151 155 135 109 123  
  90th 181 180 180 168 175  
Percentile FDA Days from Filing to First Actionf            
  25th 30(35) 22(25) 18(24) 19(25) 25(27)  
  50th (Median) 68(80) 46(65) 34(47) 32(40) 37(43)  
  75th 155(177) 173(178) 132(152) 101(116) 101(116)  
  90th 206(287) 202(279) 189(232) 147(180) 166(177)  
Percentile FDA Days from Filing to First Actiong            
  25th

32(36)

22(24)

19(25)

19(25)

25(25)

 
  50th (Median)

72(93)

49(68)

36(51)

34(42)

37(42)

 
  75th

169(180)

174(181)

140(163)

107(123)

99(123)

 
  90th

210(347)

203(314)

190(254)

174(189)

166(189)

 
             
Number Pending as of 9/30/01            
  Active 0 0 2 2 19  
  (Active and Overdue) 0 0 0 0 (4)  
  On Holdh 4 4 10 23 24  
Total 4 4 12 25 43  
             
Summary of PMA Supplement Receipt Cohort            
  Approved 365 421 440 412 195  
  Denied 0 0 0 0 0  
  Withdrawn 26 30 32 20 11  
  Other 8 51 53 77 48  
  Under Review 0 0 2 2 19  
  On Holdh 4 4 10 23 24  
Total 403 506 537 534 297  
             
*/ For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through March 31, 2001 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a during which time PMA from its filing date until it receives final approval. Panel Track Supplement times are quantified in Table 8.
a/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/ The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
c/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

Table 8. PMA Panel Track Supplement Receipt Cohort Performance *
FY97 — FY01

 

FY97

FY98

FY99

FY00

FY01

 
PMA Panel Track Supplements Received            
Filing Decisionsa            
  Filed

6

9

15

11

6

 
  Not Filed

1

1

0

1

0

 
  Number of Filing/Not Filing Decisions within 45 Days

5

9

10

10

5

 
  Average Days/Cycle

45

42

45

39

40

 
             
PMA Panel Track Supplement Final Actionsb            
  Approvals

5

9

13

6

3

 
  Denials

0

0

0

0

0

 
  Otherc

2

2

3

2

1

 
             
Filing to First Action Excluding withdrawals, conversions, etc.d          
  Number Received and Filed

7

9

15

11

6

 
  Number of First Actions

7

9

15

11

5

 
  Average FDA Days

165

116

134

119

130

 
  Median FDA Days

180

106

162

135

153

 
  Number (%) of First Actions within 180 Days

4(57)

7(78)

13(87)

10(91)

5(100)

 
             
Filing First Action Including withdrawals, conversions, etc.e          
  Number Received and Filed

7

9

15

11

6

 
  Number of First Actions

7

9

15

11

5

 
  Average FDA Days

165

116

134

119

130

 
  Median FDA Days

180

106

162

135

153

 
  Number (%) of First Actions within 180 Days

4(57)

7(78)

13(87)

10(91)

5(100)

 
             
Filing to Final Action Excluding withdrawals, conversions, etc.f          
  Number Received and Filed

5

8

12

6

2

 
  Number of First Actions

5

8

12

6

2

 
  Average FDA (Total) Review Days

446(703)

287(343)

255(285)

214(231)

208(226)

 
  Median FDA (Total) Review Days

454(454)

237(269)

192(239)

214(248)

208(226)

 
  Number (%) of Final Actions within 180 Days

0(0)

1(13)

5(42)

2(33)

1(50)

 
  Number (%) of Final Actions within 180 Total Days

0(0)

0(0)

4(33)

2(33)

1(50)

 
             
Filing to Final Action Including withdrawals, conversions, etc.g          
  Number Received and Filed

7

9

13

8

3

 
  Number of First Actions

7

9

13

8

3

 
  Average FDA (Total) Review Days

407(692)

275(374)

253(281)

235(277)

198(226)

 
  Median FDA (Total) Review Days

454(454)

232(296)

199(235)

214(291)

179(226)

 
  Number (%) of Final Actions within 180 Days

1(14)

2(22)

6(46)

3(38)

2(67)

 
  Number (%) of Final Actions within 180 Total Days

0(0)

0(0)

4(31)

2(25)

1(33)

 
Average Number of FDA Cycles from Receipt to Final            
Action Including withdrawals, conversions, etc.b

2.3

1.8

1.8

1.5

1.3

 
             
Percentile FDA Days from Filing to First Actiond            
  25th

143

87

84

88

86

 
  50th (Median)

180

106

162

135

153

 
  75th

190

175

179

157

179

 
  90th

196

227

185

175

---

 
             
Percentile FDA Days from Filing to First Actione            
  25th

143

87

84

88

86

 
  50th (Median)

180

106

162

135

153

 
  75th

190

175

179

157

179

 
  90th

196

227

185

175

---

 
             
Percentile FDA (Total) Days from Filing to Final Actionf  
  25th

190(209)

229(235)

178(179)

144(144)

168(168)

 
  50th (Median)

454(454)

237(269)

192(239)

214(248)

208(226)

 
  75th

641(925)

355(474)

373(373)

266(295)

248(283)

 
  90th

760(1736)

484(560)

433(488)

313(313)

248(283)

 
             
Percentile FDA (Total) Days from Filing to Final Actiong  
  25th

186(209)

227(237)

179(179)

140(177)

168(168)

 
  50th (Median)

454(454)

232(296)

199(235)

214(291)

179(226)

 
  75th

641(925)

261(484)

361(361)

290(317)

248(283)

 
  90th

760(1736)

484(621)

433(488)

458(510)

248(283)

 
             
Number Pending as of 9/30/01            
  Active

0

0

2

2

4

 
  (Active and Overdue)

0

0

0

0

(1)

 
  On Holdh

4

4

10

23

2

 
Total

4

4

12

25

6

 
             
Summary of PMA Supplement Receipt Cohort            
  Approved

5

9

13

6

3

 
  Denied

0

0

0

0

0

 
  Withdrawn

2

1

3

2

1

 
  Other

0

1

0

0

0

 
  Under Review

0

0

1

1

4

 
  On Holdh

0

0

3

3

2

 
Total

7

11

20

12

10

 
*/ For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through March 31, 2001 (first 6 months of the fiscal year). The averag elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time ot was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
a/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/ The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
c/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/
The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.


Table 9. HDE Submissions Received
FY97 — FY01

TYPE OF SUBMISSION

NUMBER RECEIVED

 
 

FY97

FY98

FY99

FY00

FY01

 
Humanitarian Device Exemptions (HDEs)            
  Original Applications

4

8

12

11

5

 
  Amendments

10

32

55

56

62

 
  Supplements

0

0

4

10

16

 
  Amendments to Supplements

0

0

3

12

8

 
  Reports for Original Applications

0

0

6

9

24

 
  Reports for Supplements

0

0

0

0

0

 
HDE Subtotal

14

40

80

98

115