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FY 2002 ODE Annual Report - Part 7 - 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. 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 14) and 2 (page 15) for general summary of major submissions received and completed.

 Table 3.  PMA/HDE/IDE/510(k) Submissions Received
FY 98 - FY 02

TYPE OF SUBMISSION

NUMBER RECEIVED

 

FY98

FY99

FY00

FY01

FY02

 
Premarket Approval (PMAs)            
  Original Applications

48

64

67

71

48

 
  Amendments

735

743

975

753

758

 
  Supplements

517

557

546

641

644

 
  Amendments to Supplements

863

954

933

919

864

 
  Reports for Original Applications

430

423

420

492

583

 
  Reports for Supplements

0

0

0

0

0

 
  Master Files

95

69

45

37

44

 
PMA Subtotal

2,688

2,810

2,986

2,913

2,941

 
Humanitarian Device Exemptions (HDEs)            
  Original Applications

8

12

11

5

5

 
  Amendments

32

55

56

62

53

 
  Supplements

0

4

10

16

16

 
  Amendments to Supplements

0

3

12

8

20

 
  Reports for Original Applications

0

6

9

24

29

 
  Reports for Supplements

0

0

0

0

0

 
HDE Subtotal

40

80

98

115

93

 
Investigational Device Exemptions (IDEs)            
  Original Applications

322

304

311

284

312

 
  Amendments

226

275

240

206

252

 
  Supplements

4,277

4,127

4,388

4,811

4,724

 
IDE Subtotal

4,825

4,706

4,939

5,301

5,288

 
Premarket Notification (510(k)s)            
  Original Notifications

4,623

4,458

4,202

4,248

4,320

 
  Supplements

2,023

1,872

1,742

1,579

1,780

 
  Amendments

3,692

2,962

2,953

2,620

2,385

 
510(k) Subtotal

10,338

9,292

8,897

8,447

8,485

 
PMA/HDE/IDE/510(k) Total

17,861

16,812

16,919

16,773

16,807

 

 

 Table 4.  Original PMA Decision Cohort Performance
FY 98 - FY 02

 

FY 98

FY 99

FY 00

FY 01

FY 02

 
Number Received

48

64

67

71

48

 
PMA Action            
  Filing Decisions            
    Filed

42

55

64

62

43

 
    Not Filed

10

6

4

5

3

 
    Others

0

0

0

0

0

 
Filing Decisions Subtotal

52

61

68

67

46

 
  Scientific Review Decisions            
    Major Deficiencies

28

27

51

35

29

 
    Minor Deficiencies

9

4

11

4

2

 
    Othera

130

126

111

95

91

 
Scientific Review Decisions Subtotals

167

157

173

134

122

 
  Approval Decisions            
    Approvals

40

37

42

53

41

 
    Approvable

9

10

33

18

17

 
    Not Approvable

12

1

4

10

10

 
    Denials

0

0

0

0

0

 
Approved Decision Subtotal

61

48

79

81

68

 
Total PMA Actions

280

266

320

282

236

 
Average Review Time (Days) for Approvalsb            
    FDA

158

154

173

129

160

 
    Non-FDA

41

26

41

43

53

 
    Total

199

180

214

172

213

 
Average Elapsed Time (Days) for Approvalsc            
    FDA

291

316

254

257

259

 
    Non-FDA

122

118

114

154

105

 
    Total

413

434

368

411

364

 
Number under Review at End of Periodd            
    Activee

62

68

45

46

34

 
    (Active and Overdue)

(35)

(27)

(10)

(6)

0

 
    On Holdf

43

40

39

39

31

 
    Total 105 108 84 85 65  
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 98 – FY 02

 

FY97

FY98

FY99

FY00

FY01

Original PMAs Received          
  PMAs

32

48

60

58

12

  Expedited PMAs

6

7

8

9

4

Total

38

55

68

67

16

           
Filing Decisionsa          
  Filed

38

55

68

67

16

  Not Filed

3

1

3

3

0

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

30(73)

44(79)

54(76)

47(66)

13(81)

  Average Days/Cycle

44

42

41

44

43

           
Final Actionsb          
  Approvals

26

52

43

43

3

  Denials

0

0

0

0

0

  Otherc

20

12

21

13

4

Total

46

64

64

56

7

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

38

55

68

67

16

  Number of First Actions

37

55

63

67

16

  Average FDA Days

134

145

132

132

126

  Median FDA Days

145

147

143

133

126

  Number (%) of First Actions with 180 Days

32(86)

43(78)

63(100)

65(97)

15(94)

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

38

55

68

67

16

  Number of First Actions

38

55

68

67

16

  Average FDA Days

134

145

133

132

126

  Median FDA Days

141

147

136

133

126

  Number (%) of First Actions with 180 Days

33(87)

43(78)

68(100)

65(97)

15(94)

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

38

55

68

67

16

  Number of Final Actions

28

49

46

43

3

  Average FDA (Total) Elapsed Time

235(362)

277(394)

222(326)

218(265)

203(209)

  Median FDA (Total) Elapsed Time

198(220)

251(354)

181(280)

182(234)

178(180)

  Number (%) of Final Actions with 180 FDA Days

12(43)

8(16)

22(48)

19(44)

2(67)

Number (%) of Final Actions with 180 Total Days

10(36)

5(10)

7(15)

11(26)

2(67)

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

38

55

68

67

16

  Number of Final Actions

37

55

66

51

3

  Average FDA (Total) Elapsed Time

247(448)

274(424)

205(356)

208(294)

203(209)

  Median FDA (Total) Elapsed Time

181(289)

252(372)

179(284)

181(263)

178(180)

  Number (%) of Final Actions with 180 FDA Days

19(51)

10(18)

40(61)

25(49)

2(67)

  Number (%) of Final Actions with 180 Total Days

11(30)

5(9)

12(18)

11(22)

2(67)

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

1.7

2.1

1.6

1.5

1.3

           
Percentile FDA Days from Filing to First Actiond
  25th

99

115

99

105

109

  50th (Median)

145

147

143

133

126

  75th

175

179

177

176

157

  90th

192

227

180

179

178

           
Percentile FDA Days from Filing to First Actionc
  25th

99

115

99

105

109

  50th (Median)

141

147

136

133

126

  75th

174

179

175

176

157

  90th

181

227

179

179

178

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

154(158)

207(253)

175(205)

176(179)

162(178)

  50th (Median)

198(220)

251(354)

181(280)

182(234)

178(180)

  75th

328(476)

330(491)

278(424)

261(327)

270(270)

  90th

392(915)

405(660)

341(498)

335(418)

270(270)

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

141(178)

201(254)

162(204)

165(180)

162(178)

  50th (Median)

181(289)

252(372)

179(284)

181(263)

178(180)

  75th

289(684)

327(587)

272(460)

259(357)

270(270)

  90th

392(940)

404(757)

319(721)

311(475)

270(270)

           
  Active

0

0

1

6

8

  (Active and Overdue)

0

0

0

0

0

  On Holdh

2

0

2

9

5

Total

2

0

3

15

13

           
Summary of PMA Receipt Cohort          
  Approved

26

52

43

43

3

  Denied

0

0

0

0

0

  Withdrawn

11

6

16

11

2

  Other

9

6

5

2

2

  Under Review

0

0

1

6

8

  On Holdh

2

0

2

9

5

Total

48

64

67

71

20

*/ For each fiscal year, September 30, 2002 was used as the cutoff date. The FY02 cohort represents only receipts through March 31, 2002 (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 agency 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 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
             
Number Received

517

557

546

641

644

 
PMA Supplement Actions            
Panel Track Filing Decisionsa            
   Filed

15

17

15

11

23

 
   Not Filed

2

2

3

4

1

 
   Other

0

0

0

0

0

 
Filing Decision Subtotal

17

19

18

15

24

 
             
Scientific Review Decisions            
   Major Deficiencies

4

12

13

9

12

 
   Minor Deficiencies

2

0

1

0

0

 
   Otherb

72

76

83

78

93

 
Scientific Review Decisions Subtotal

78

88

97

87

105

 
             
Approval Decisions            
   Panel Track Approvalsc

5

11

11

11

16

 
   Nonpanel Track Approvals

416

429

463

431

516

 
   Approvable

91

95

100

100

102

 
   Not Approvable

63

62

59

52

51

 
Approval Decision Subtotal

575

597

633

594

685

 
             
Total PMA Supplement Actions

670

704

748

696

814

 
             
Average Review Time (Days) for Approvalsd            
   FDA

82

76

76

71

85

 
   Non-FDA

25

18

18

26

20

 
Total

107

94

94

97

105

 
             
Average Elapsed Time (Days) for Approvalse            
   FDA

109

92

95

78

96

 
   Non-FDA

43

27

26

32

28

 
Total

152

119

121

110

124

 
             
Number Under Review at End of Periodf            
   Activeg

143

156

99

154

126

 
   (Active and Overdue)

(2)

(2)

(1)

(8)

0

 
   On Holdh

56

65

82

95

98

 
Total

199

221

181

249

224

 
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 of 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, 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.
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 98 - FY 02

 

FY98

FY99

FY00

FY01

FY02

 
PMA Supplements Filed            
  PMA Supplements

501

530

533

623

345

 
  Expedited PMA Supplements

1

2

1

0

0

 
Total

502

532

534

623

345

 
             
PMA Supplement Final Actionsa            
  Approvals

421

442

420

465

263

 
  Denials

0

0

0

0

0

 
  Otherb

81

92

101

138

50

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

502

532

534

623

345

 
  Number of First Actions

482

513

517

602

329

 
  Average FDA Days

81

72

63

71

72

 
  Median FDA Days

57

36

37

36

36

 
  Number (%) of First Actions within 180 Days

436(90)

464(90)

505(98)

569(95)

316(96)

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

502

532

534

623

345

 
  Number of First Actions

500

532

532

620

343

 
  Average FDA Days

80

73

64

71

75

 
  Median FDA Days

47

35

35

35

36

 
  Number (%) of First Actions within 180 Days

453(91)

481(90)

520(98)

586(95)

326(95)

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

502

532

534

623

345

 
  Number of First Actions

455

488

493

574

294

 
  Average FDA (Total) Review Days

91(115)

77(107)

68(90)

76(93)

70(78)

 
  Median FDA (Total) Review Days

46(65)

34(47)

33(42)

33(42)

35(38)

 
  Number (%) of Final Actions within 180 Days

376(83)

424(87)

464(94)

517(90)

276(94)

 
  Number (%) of Final Actions within 180 Total Days

352(77)

402(82)

437(89)

490(85)

273(93)

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

502

532

534

623

345

 
  Number of First Actions

498

529

521

602

313

 
  Average FDA (Total) Review Days

94(129)

85(129)

69(98)

77(96)

72(83)

 
  Median FDA (Total) Review Days

49(68)

36(55)

35(43)

33(43)

35(41)

 
  Number (%) of Final Actions within 180 Days

411(83)

455(86)

491(94)

542(90)

291(93)

 
  Number (%) of Final Actions within 180 Total Days

371(74)

420(79)

454(87)

509(85)

284(91)

 
             
Average Number of FDA Cycles from Receipt to Final Action Including withdrawls, conversations, etc.a 1.1 1.1 1.1 1.0 1.0  
             
Percentile FDA Days from Filing to First Actiond            
  25th 22 19 21 25 22  
  50th (Median) 57 36 37 36 36  
  75th 169 147 113 127 140  
  90th 183 189 176 180 180  
             
Percentile FDA Days from Filing to First Actione            
  25th 22 19 20 24 22  
  50th (Median) 47 35 35 35 36  
  75th 155 135 109 120 135  
  90th 180 180 168 178 178  
             
Percentile FDA (Total) Days from Filing to Final Actionf            
  25th 22(25) 18(24) 19(25) 24(27) 21(27)  
  50th (Median) 46(65) 34(47) 33(42) 33(42) 35(38)  
  75th 173(178) 138(154) 105(123) 123(145) 118(136)  
  90th 202(279) 190(236) 176(190) 180(204) 178(178)  
             
Percentile FDA (Total) Days from Filing to Final Actiong            
  25th

22(24)

19(25)

20(25)

23(27)

21(27)

 
  50th (Median)

49(68)

36(55)

35(43)

33(43)

35(41)

 
  75th

174(181)

146(168)

110(139)

123(151)

121(143)

 
  90th

203(314)

196(280)

176(209)

180(209)

178(180)

 
             
Number Pending as of 9/30/01            
  Active 0 0 0 2 8  
  (Active and Overdue) 0 0 0 0 0  
  On Holdh 4 3 13 19 24  
Total 4 3 13 21 32  
             
Summary of PMA Supplement Receipt Cohort            
  Approved 421 442 420 465 263  
  Denied 0 0 0 0 0  
  Withdrawn 30 38 24 27 16  
  Other 51 54 77 111 34  
  Under Review 0 0 0 2 8  
  On Holdh 4 3 13 19 24  
Total 506 537 534 624 345  
*/ For each fiscal year, September 30, 2002 was used as the cutoff date. The FY02 cohort represents only receipts through March 31, 2002 (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. Panel Track Supplement times are quantified in Table 8.
a/ The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
b/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
c/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt. 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 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 *
FY98 – FY02

 

FY98

FY99

FY00

FY01

FY02

 
PMA Panel Track Supplements Filed            
  Panel Track PMA Supplements

9

11

8

13

12

 
  Expedited Panel Track PMA Supplements

0

4

3

1

3

 
Total

9

15

11

14

15

 
             
Filing Decisionsa            
  Filed

9

15

11

14

15

 
  Not Filed

1

0

1

2

1

 
  Number of Filing/Not Filing Decisions within 45 Days

9

10

10

14

11

 
  Average Days/Cycle

42

45

39

38

50

 
             
PMA Panel Track Supplement Final Actionsb            
  Approvals

9

14

6

10

9

 
  Denials

0

0

0

0

0

 
  Otherc

2

4

4

2

0

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

9

15

11

14

15

 
  Number of First Actions

9

15

11

14

15

 
  Average FDA Days

116

134

119

136

128

 
  Median FDA Days

106

162

135

135

148

 
  Number (%) of First Actions within 180 Days

7(78)

13(87)

10(91)

13(93)

14(93)

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

9

15

11

14

15

 
  Number of First Actions

9

15

11

14

15

 
  Average FDA Days

116

134

119

136

128

 
  Median FDA Days

106

162

135

135

148

 
  Number (%) of First Actions within 180 Days

7(78)

13(87)

10(91)

13(93)

14(93)

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

9

15

11

14

15

 
  Number of First Actions

8

13

6

9

9

 
  Average FDA (Total) Review Days

287(343)

274(327)

214(231)

214(255)

183(203)

 
  Median FDA (Total) Review Days

237(269)

199(252)

214(248)

180(180)

187(216)

 
  Number (%) of Final Actions within 180 Days

1(13)

5(38)

2(33)

5(56)

4(44)

 
  Number (%) of Final Actions within 180 Total Days

0(0)

4(31)

2(33)

4(44)

3(33)

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

9

15

11

14

15

 
  Number of First Actions

9

14

10

10

9

 
  Average FDA (Total) Review Days

275(374)

272(321)

255(363)

210(252)

183(203)

 
  Median FDA (Total) Review Days

232(296)

217(244)

226(304)

180(203)

187(216)

 
  Number (%) of Final Actions within 180 Days

2(22)

6(43)

3(30)

6(60)

4(44)

 
  Number (%) of Final Actions within 180 Total Days

0(0)

4(29)

2(20)

4(40)

3(33)

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

1.8

2.0

1.8

1.5

1.3

 
             
Percentile FDA Days from Filing to First Actiond            
  25th

87

84

88

81

67

 
  50th (Median)

106

162

135

135

148

 
  75th

175

179

157

174

175

 
  90th

227

185

175

180

176

 
             
Percentile FDA Days from Filing to First Actione            
  25th

87

84

88

81

67

 
  50th (Median)

106

162

135

135

148

 
  75th

175

179

157

174

175

 
  90th

227

185

175

180

176

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

229(235)

179(179)

144(144)

174(174)

171(175)

 
  50th (Median)

237(269)

199(252)

214(248)

180(180)

187(216)

 
  75th

355(474)

385(385)

266(295)

248(283)

200(223)

 
  90th

484(560)

450(494)

313(313)

313(539)

216(254)

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

227(237)

179(179)

144(209)

174(174)

171(175)

 
  50th (Median)

232(296)

217(244)

226(304)

180(203)

187(216)

 
  75th

261(484)

385(385)

313(510)

248(283)

200(223)

 
  90th

484(621)

450(494)

451(709)

301(440)

216(254)

 
             
Number Pending as of 9/30/02            
  Active

0

0

1

2

5

 
  (Active and Overdue)

0

0

0

0

0

 
  On Holdh

0

2

1

3

0

 
Total

0

2

2

5

5

 
             
Summary of PMA Supplement Receipt Cohort            
  Approved

9

14

6

10

9

 
  Denied

0

0

0

0

0

 
  Withdrawn

1

3

4

2

0

 
  Other

1

1

0

0

0

 
  Under Review

0

0

1

2

5

 
  On Holdh

0

2

1

3

0

 
Total

11

20

12

17

14

 
*/ For each fiscal year, September 30, 2002 was used as the cutoff date. The FY02 cohort represents only receipts through March 31, 2002 (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/ 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
FY98 – FY02

TYPE OF SUBMISSION

NUMBER RECEIVED

 
 

FY98

FY99

FY00

FY01

FY02

 
Humanitarian Device Exemptions (HDEs)            
  Original Applications

8

12

11

5

5

 
  Amendments

32

55

56

62

54

 
  Supplements

0

4

10

16

16

 
  Amendments to Supplements

0

3

12

8

20

 
  Reports for Original Applications

0

6

9

24

29

 
  Reports for Supplements

0

0

0

0

0

 
Total

40

80

98

115

124