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FY 2004 ODE Annual Report - Part 7 - Operational Summary

 

[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 01 - FY 04

TYPE OF SUBMISSION

NUMBER RECEIVED

 

FY01

FY02

FY03

FY04

OIVD/ODE

FY04

ODE Only

Premarket Approval (PMAs)          
Original Applications

71

49

54

51

37

Amendments

746

748

564

611

545

Supplements

641

645

669

635

565

Amendments to Supplements

920

860

817

689

635

Reports for Original Applications

494

583

703

743

681

Reports for Supplements

0

1

0

1

0

Master Files

37

44

44

57

57

PMA Subtotal

2,909

2,930

2,851

2,792

2,525

Humanitarian Device Exemptions (HDEs)          
Original Applications

5

5

10

9

9

Amendments

62

53

41

53

53

Supplements

16

16

29

29

28

Amendments to Supplements

8

20

25

18

17

Reports for Original Applications

24

29

37

16

16

Reports for Supplements

0

0

0

0

0

HDE Subtotal

115

93

142

125

123

Investigational Device Exemptions (IDEs)          
Original Applications

284

312

242

226

222

Amendments

206

252

216

167

167

Supplements

4,811

4,724

4,414

4,312

4,298

IDE Subtotal

5,301

5,288

4,872

4,705

4,687

Premarket Notification (510(k)s)          
Original Notifications

4,248

4,320

4,247

3,635

3, 110

Supplements

1,579

1,780

1,856

2,041

1,787

Amendments

2,620

2,385

1,690

1,603

1,408

510(k) Subtotal

8,447

8,485

7,793

7,279

6,305

PMA/HDE/IDE/510(k) Total

16,772

16,796

15,658

14,558

13,640

 Table 4. Original PMA Decision Cohort Performance
FY 01- FY 04

 

FY 01

FY 02

FY03

FY04 OIVD/ ODE

FY04 ODE Only

Number Received

71

49

54

51

37

PMA Action          
Filing Decisions          
Filed

62

44

43

55

40

Not Filed

5

3

11

4

4

Others

0

0

0

0

0

Filing Decisions Subtotal

67

47

54

59

44

Scientific Review Decisions          
Major Deficiencies

35

29

29

46

32

Minor Deficiencies

4

2

1

0

0

Other a

94

91

57

79

70

  Scientific Review Decisions Subtotal

133

122

87

125

102

Approval Decisions          
Approvals

53

41

31

39

30

Approvable

19

17

16

15

15

Not Approvable

10

10

10

8

7

Denials

0

0

0

0

0

Approval Decision Subtotal

82

68

57

62

52

Total PMA Actions

282

237

198

246

198

Average Review Time (Days) for Approvals b          
FDA

129

161

151

142

155

Non-FDA

43

52

70

143

73

Total

172

213

221

285

228

Average Elapsed Time (Days) for Approvals c          
FDA

257

260

246

260

266

Non-FDA

154

104

113

243

170

Total

411

364

359

503

436

Number under Review at End of Period d          
Active e

56

45

38

29

27

(Active and Overdue)

(16)

(10)

(5)

(2)

(2)

On Hold f

39

31

48

54

43

Total

95

76

86

83

70

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 abandonment 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 elapsed 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 01– FY 04

 

FY01

FY02

FY03

FY04 OIVD/ODE

FY04 ODE Only

   

 

 

 

 
Original PMAs Filed  

 

 

 

 
PMAs

59

32

40

21

11

Expedited PMAs

8

9

3

9

8

Total

67

41

43

30

19

   

 

 

 

 
Filing Decisions a  

 

 

 

 
Filed

67

41

43

30

19

Not Filed

3

0

3

3

3

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

47(66)

31(76)

32(71)

25(76)

16(73)

Average Days/Cycle

44

41

42

38

39

 

 

       
Final Actions b

 

       
Approvals

48

31

26

6

4

Denials

0

0

0

0

0

Other c

17

11

6

0

0

Total

65

42

32

6

4

         

 

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

67

41

43

30

19

Number of First Actions

67

41

43

30

19

Average FDA Days

132

136

126

110

113

Median FDA Days

133

143

129

110

111

Number (%) of First Actions with 180 Days

65(97)

38(93)

42(98)

30(100)

19(100)

 

 

 

 

 

 

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

67

41

43

30

19

Number of First Actions

67

41

43

30

19

Average FDA Days

132

136

126

110

113

Median FDA Days

133

143

129

110

111

Number (%) of First Actions with 180 Days

65(97)

38(93)

42(98)

30(100)

19(100)

         

 

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

67

41

43

30

19

Number of Final Actions

49

31

26

6

4

Average FDA (Total) Elapsed Time

254(343)

256(389)

210(277)

157(183)

176(215)

Median FDA (Total) Elapsed Time

193(263)

243(341)

195(262)

172(181)

177(220)

Number (%) of Final Actions with 180 FDA Days

19(39)

11(35)

11(42)

5(83)

3(75)

Number (%) of Final Actions with 180 Total Days

11(22)

4(13)

5(19)

3(50)

1(25)

 

 

 

 

 

 

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

67

41

43

30

19

Number of Final Actions

61

36

30

6

4

Average FDA (Total) Elapsed Time

240(400)

250(407)

202(296)

157(183)

176(215)

Median FDA (Total) Elapsed Time

191(316)

237(375)

183(280)

172(181)

177(220)

Number (%) of Final Actions with 180 FDA Days

26(43)

14(39)

15(50)

5(83)

3(75)

Number (%) of Final Actions with 180 Total Days

11(18)

4(11)

5(17)

3(50)

1(25)

 

 

 

 

 

 

Average Number of FDA Cycles from Receipt to Final Action

 

 

 

 

Including withdrawals, conversions, etc. b

1.7

1.8

1.5

1.3

1.5

 

FY01

FY02

FY03

FY04

OIVD/

ODE

FY04

ODE

Only

   

 

 

 

 
Percentile FDA Days from Filing to First Action d  

 

 

 

 
25th

105

108

94

89

84

50th (Median)

133

143

129

110

111

75th

176

176

174

145

157

90th

179

180

178

176

178

     

 

   
Percentile FDA Days from Filing to First Action e    

 

   
25 th

105

108

94

89

84

50th (Median)

133

143

129

110

111

75th

176

176

174

145

157

90th

179

180

178

176

178

     

 

   
Percentile FDA (Total) Days from Filing to Final Action f      

 

25th

177(180)

178(270)

174(205)

142(142)

172(181)

50th (Median)

193(263)

243(341)

195(262)

172(181)

177(220)

75th

287(379)

335(435)

267(321)

177(245)

179(248)

90th

378(733)

381(699)

302(437)

181(251)

181(251)

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

177(198)

178(277)

172(250)

142(142)

172(181)

50th (Median)

191(316)

237(375)

183(280)

172(181)

177(220)

75th

271(469)

318(483)

265(338)

177(245)

179(248)

90th

358(786)

395(699)

297(482)

181(251)

181(251)

 

 

 

 

 

 

Active

1

0

7

8

7

(Active and Overdue)

(1)

(0)

(1)

(1)

(1)

On Hold h

5

7

15

13

5

Total

6

7

22

21

12

 

 

 

 

 

 

Approved

48

31

26

6

4

Denied

0

0

0

0

0

Withdrawn

15

9

6

0

0

Other

2

2

0

0

0

Under Review

1

0

7

8

7

On Hold h

5

7

15

13

5

Total

71

49

54

27

16

*/ For each fiscal year, September 30, 2004 was used as the cutoff date. The FY04 cohort represents only receipts through March 31, 2004 (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 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

   

 

     
Number Received

641

645

666

635

565

   

 

     
PMA Supplement Actions  

 

     
Panel Track Filing Decisions a  

 

     
Filed

11

24

5

6

6

Not Filed

4

1

1

1

1

Other

0

0

0

0

0

Filing Decision Subtotal

15

25

6

7

7

   

 

     
Scientific Review Decisions  

 

     
Major Deficiencies

9

12

6

4

3

Minor Deficiencies

0

0

0

0

0

Other b

78

93

91

87

78

Scientific Review Decisions Subtotal

87

105

97

91

81

   

 

     
Approval Decisions  

 

     
Panel Track Approvals c

11

16

11

5

4

Nonpanel Track Approvals

431

517

483

461

420

Approvable

100

102

96

68

65

Not Approvable

52

51

47

64

62

Approval Decision Subtotal

594

686

637

598

551

 

 

       
Total PMA Supplement Actions

696

816

740

696

639

   

 

     
Average Review Time (Days) for Approvals d  

 

     
FDA

71

85

72

68

67

Non-FDA

26

20

21

39

19

Total

97

105

93

107

86

   

 

     
Average Elapsed Time (Days) for Approvals e  

 

     
FDA

78

96

85

81

80

Non-FDA

32

28

26

46

26

Total

110

124

111

127

106

   

 

     
Number Under Review at End of Period f  

 

     
Active g

155

127

119

112

106

(Active and Overdue)

(9)

(2)

(4)

(4)

(4)

On Hold h

92

95

110

99

94

Total

247

222

229

211

200

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, excludesall 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 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD/ODE

FY04 ODE Only

PMA Supplements Filed          
PMA Supplements

623

625

654

305

279

Expedited PMA Supplements

0

0

0

0

0

Total

623

625

654

305

279

           
PMA Supplement Final Actions a          
Approvals

472

500

481

206

191

Denials

0

0

0

0

0

Other b

139

108

157

84

74

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

623

625

654

305

279

Number of First Actions

603

604

627

290

265

Average FDA Days

71

71

64

55

55

Median FDA Days

36

36

32

30

30

Number (%) of First Actions within 180 Days

570(95)

583(97)

615(98)

287(99)

263(99)

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

623

625

654

305

279

Number of First Actions

621

625

653

301

276

Average FDA Days

71

73

62

55

55

Median FDA Days

35

36

30

30

30

Number (%) of First Actions within 180 Days

587(95)

599(96)

 

 

641(98)

 

298(99)

274(99)

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

623

625

654

305

279

Number of First Actions

581

576

603

272

251

Average FDA (Total) Review Days

79(100)

77(100)

65(81)

55(62)

55(62)

Median FDA (Total) Review Days

33(43)

35(46)

30(38)

30(30)

30(30)

Number (%) of Final Actions within 180 Days

522(90)

525(91)

570(95)

265(97)

245(98)

Number (%) of Final Actions within 180 Total
Days

490(84)

500(87)

555(92)

260(96)

240(96)

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

623

625

654

305

279

Number of First Actions

610

608

633

289

264

Average FDA (Total) Review Days

81(105)

80(107)

64(81)

53(61)

54(61)

Median FDA (Total) Review Days

34(44)

36(49)

30(39)

30(31)

30(31)

Number (%) of Final Actions within 180 Days

547(90)

550(90)

600(95)

282(98)

258(98)

Number (%) of Final Actions within 180 Total
Days

509(83)

516(85)

581(92)

277(96)

253(96)

Average Number of FDA Cycles from Receipt to Final Action Including
withdrawals, conversions, ect. a

1.1

1.1

1.0

1.0

1.0

(continued)

 

FY01

FY02

FY03

FY04 OIVD /ODE

FY04 ODE Only

Percentile FDA Days from Filing to First Action d    

 

 

 

25 th

24

20

23

23

24

50th (Median)

36

36

32

30

30

75 th

127

137

117

99

99

90 th

180

179

178

175

174

 

 

       
Percentile FDA Days from Filing to First Action e

 

       
25 th

23

20

23

22

24

50th (Median)

35

36

30

30

30

75 th

120

130

101

86

88

90 th

178

177

168

152

151

         

 

Percentile FDA (Total) Days from Filing to Final Action f      

 

25 th

24(27)

19(27)

23(28)

21(26)

22(27)

50th (Median)

33(43)

35(46)

30(38)

30(30)

30(30)

75 th

124(151)

136(160)

97(113)

79(88)

83(88)

90 th

181(212)

180(215)

174(178)

149(165)

148(161)

 
Percentile FDA (Total) Days from Filing to Final Action g      

 

25 th

23(27)

20(27)

23(28)

22(26)

24(27)

50th (Median)

34(44)

36(49)

30(39)

30(31)

30(31)

75 th

126(160)

140(164)

92(113)

65(85)

75(86)

90 th

181(233)

180(239)

170(178)

148(162)

148(161)

 
 Number Pending as of 9/30/01
Active

0

0

5

5

4

(Active and Overdue)

(0)

(0)

(2)

(2)

(2)

On Hold h

13

17

16

11

11

Total

13

17

21

16

15

   

 

 

 

 

Summary of PMA Supplement Receipt Cohort
Approved

472

500

481

206

191

Denied

0

0

0

0

0

Withdrawn

28

26

30

18

14

Other

111

82

127

66

60

Under Review

0

0

5

5

4

On Hold h

13

17

16

11

11

Total

624

625

659

306

280

*/ For each fiscal year, September 30, 2004 was used as the cutoff date. The FY04 cohort represents only receipts through March 31, 2004 (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.
d/ The first action analyses includes actions as of the cutoff date for PMAs 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*
FY 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD /ODE

FY04 ODE Only

PMA Panel Track Supplements Filed          
Panel Track PMA Supplements

13

17

6

0

0

Expedited Panel Track PMA Supplements

1

3

1

2

2

Total

14

20

7

2

2

Filing Decisions a          
Filed

14

20

7

2

2

Not Filed

2

1

1

0

0

Number of Filing/Not Filing Decisions with 45

Days

14

15

7

1

1

Average Days/Cycle

38

47

37

43

43

PMA Panel Track Supplement Final Actions b          
Approvals

12

18

4

1

1

Denials

0

0

0

0

0

Other c

3

1

2

1

1

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

14

20

7

2

2

Number of First Actions

14

20

7

2

2

Average FDA Days

136

144

118

148

148

Median FDA Days

135

158

109

148

148

Number (%) of First Actions within 180 Days

13(93)

18(90)

7(100)

2(100)

2(100)

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

14

20

7

2

2

Number of First Actions

14

20

7

2

2

Average FDA Days

136

144

118

148

148

Median FDA Days

135

158

109

148

148

Number (%) of First Actions within 180 Days

13(93)

18(90)

7(100)

2(100)

2(100)

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

14

20

7

2

2

Number of First Actions

11

18

4

1

1

Average FDA (Total) Review Days

241(319)

236(301)

238(273)

169(169)

169(169)

Median FDA (Total) Review Days

221(276)

200(230)

233(254)

169(169)

169(169)

Number (%) of Final Actions within 180 Days

5(45)

6(33)

1(25)

1(100)

1(100)

Number (%) of Final Actions within 180 Total

Days

4(36)

3(17)

1(25)

1(100)

1(100)

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

14

20

7

2

2

Number of First Actions

13

19

5

1

1

Average FDA (Total) Review Days

244(341)

231(320)

238(316)

169(169)

169(169)

Median FDA (Total) Review Days

221(276)

200(234)

234(273)

169(169)

169(169)

Number (%) of Final Actions within 180 Days

6(46)

7(37)

1(20)

1(100)

1(100)

Number (%) of Final Actions within 180 Total

Days

4(31)

3(16)

1(20)

1(100)

1(100)

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

1.8

1.6

2.0

1.0

1.0

continued

 

FY01

FY02

FY03

FY04 OIVD/ ODE

FY04 ODE Only

Percentile FDA Days from Filing to First Action d  

 

 

 

 

25 th

81

119

93

126

126

50th (Median)

135

158

109

148

148

75 th

174

174

145

169

169

90 th

180

191

179

169

169

 

 

       
Percentile FDA Days from Filing to First Action e

 

       
25 th

81

119

93

126

126

50th (Median)

135

158

109

148

148

75 th

174

174

145

169

169

90 th

180

191

179

169

169

         

 

Percentile FDA (Total) Days from Filing to Final Action f      

 

25 th

174(174)

171(216)

206(207)

169(169)

169(169)

50th (Median)

221(276)

200(230)

233(254)

169(169)

169(169)

75 th

288(539)

334(415)

270(339)

169(169)

169(169)

90 th

313(555)

385(494)

305(404)

169(169)

169(169)

 
Percentile FDA (Total) Days from Filing to Final Action g      

 

25 th

175(175)

170(216)

232(234)

169(169)

169(169)

50 th (Median)

221(276)

200(234)

234(273)

169(169)

169(169)

75 th

288(539)

334(438)

244(404)

169(169)

169(169)

90 th

343(664)

385(546)

305(489)

169(169)

169(169)

Number Pending as of 9/30/02
Active

0

0

0

2

2

(Active and Overdue)

(0)

(0)

(0)

(0)

(0)

On Hold h

2

1

1

0

0

Total

2

1

1

2

2

   

 

 

 

 

Summary of PMA Supplement Receipt Cohort
Approved

12

18

4

1

1

Denied

0

0

0

0

0

Withdrawn

3

1

2

1

1

Other

0

0

0

0

0

Under Review

0

0

0

2

2

On Hold h

2

1

1

0

0

Total

17

20

7

4

4

*/ For each fiscal year, September 30, 2004 was used as the cutoff date. The FY04 cohort represents only receipts through March 31, 2004 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was nder
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
FY 01 - FY 04

TYPE OF SUBMISSION

NUMBER RECEIVED

 

FY01

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

 

Humanitarian Device Exemptions (HDEs)            
Original Applications

5

5

10

9

9

 

Amendments

62

54

41

53

53

 

Supplements

16

16

29

29

28

 

Amendments to Supplements

8

20

25

18

17

 

Reports for Original Applications

24

29

37

16

16

 

Reports for Supplements

0

0

0

0

0

 

Total

115

124

142

125

123

 

 

 Table 10. Original HDE Decision Cohort Performance
FY 01 - FY 04

 

FY 01

FY 02

FY03

FY04 OIVD /ODE

FY04 ODE Only

Number Received

5

5

10

9

8

HDE Action          
Filing Decisions          
Filed

6

6

6

7

6

Not Filed

1

1

5

2

2

Others a

0

0

2

0

0

Filing Decisions Subtotal

7

7

13

9

8

Scientific Review Decisions          
Major Deficiencies

7

6

4

5

3

Minor Deficiencies

6

2

3

3

3

Other b

2

0

2

13

12

Scientific Review Decisions Subtotals

15

8

9

21

18

Approval Decisions          
Approvals

4

6

2

6

5

Approvable

0

0

0

3

2

Not Approvable

0

0

0

0

0

Denials

0

0

0

0

0

Approved Decision Subtotal

4

6

2

9

7

Other Final Decisions c

4

2

2

5

5

Total HDE Actions

30

23

26

44

38

           
Filing to First Action d          
Number of First Actions

6

6

3

7

7

Average Number of FDA Days

42

53

48

52

52

Number of First Actions Within 75 Days

6

5

2

7

7

Average Elapsed Time (Days) for Approvals e          
FDA

143

175

152

182

195

Non-FDA

100

127

96

94

92

Total

243

302

248

276

287

           
Average Number of FDA Cycles from Receipt to Final Action f 1.9

2.1

2.0

2.0

2.0

           
Number under Review at End of Period g          
Active h

1

1

4

4

4

Active and Overdue

0

0

0

1

1

On Hold i

6

3

6

4

3

Total

7

4

10

9

8

a/ Includes interim action, placing a file on hold, such as jurisdiction issue, and 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
FY 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD/
ODE

FY04 ODE Only

 

 

 

 

 

 

 

 

Number Received

16

16

29

29

28

 

 

 

 

 

 

 

 

HDE Supplement Actions

 

 

 

 

 

 

Scientific Review Decisions

 

 

 

 

 

 

Major Deficiencies

0

0

0

3

3

 

Minor Deficiencies

0

0

1

2

2

 

Other a

1

1

3

3

3

 

Scientific Review Decisions Subtotal

1

1

4

8

8

 

 

 

 

 

 

 

 

Approval Decisions

 

 

 

 

 

 

Approvals

11

13

24

23

22

 

Approvable

0

6

5

6

6

 

Not Approvable

1

6

6

4

3

 

Denials

0

0

0

0

0

 

Approval Decision Subtotal

12

25

35

33

31

 

Other Final Decisions b

1

1

2

7

7

 

Total HDE Actions

13

27

37

40

38

 

 

 

 

 

 

 

 

Filing to First Action c

 

 

 

 

 

 

Number of First Actions

12

17

29

39

37

 

Average Number of FDA Days

52

53

37

39

36

 

Number of First Actions within 75 Days

8

16

26

18

18

 

 

 

 

 

 

 

 

Average Elapsed Time (Days) for Approvals d

 

 

 

 

 

 

FDA

46

60

43

66

61

 

Non-FDA

0

14

52

29

29

 

Total

46

74

95

95

90

 

 

 

 

 

 

 

 

Average Number of FDA Cycles from

 

 

 

 

 

 

Receipt to Final Action e

1.0

1.3

1.0

1.2

1.2

 

 

 

 

 

 

 

 

Number Under Review at End of Period f

 

 

 

 

 

 

Active g

4

4

5

7

7

 

(Active and Overdue)

0

0

0

0

0

 

On Hold h

1

4

6

4

4

 

Total

5

8

11

11

11

 

a/ Includes actons that did not result in a final decision, such as GMP deficiency letter, an applicant-directed hold, official correspondence concerning the status of the supplement or other miscellaneous administrative action.
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 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

 

 

   

 

 

Number Received

284

312

242

226

222

           
Number of Decisions          
Approved

208

209

146

149

146

Not Approved

53

75

78

53

52

Other a

23

23

22

19

19

Total

284

307

246

221

217

           
Percent (%) of Approvals Made during First          
Review Cycle b

80

74

65

74

74

           
Average FDA Review Time (days)

28

28

27

28

28

           
Percent (%) of Decisions Made within 30 Days

100

99

100

100

100

           
Number under Review at End of Period c

18

22

18

23

23

           
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 01 - FY 04

 

 

FY01

FY02

FY03

FY04 OIVD /ODE

FY04 ODE Only

 

 

 

 

 

 

 

 

Amendments Received a

206

252

216

167

167

 

 

 

 

 

 

 

 

Decisions on Amendments

 

 

 

 

 

 

Approved

73

86

73

61

61

 

Not Approved

39

55

40

27

27

 

Other b

95

110

104

74

74

 

Total

207

251

217

162

162

 

 

 

 

 

 

 

 

Average FDA Review Time (days)

18

18

19

18

18

 

 

 

 

 

 

 

 

Percent (%) of Decisions Made within 30 Days

99

100

100

100

100

 

 

 

 

 

 

 

 

Average Approval Time (days)

For IDEs with Amendments

 

 

 

 

 

 

FDA Time

59

68

68

61

61

 

Non-FDA Time

82

67

112

100

100

 

Total Time c

141

135

180

161

161

 

 

 

 

 

 

 

 

Number of Amendments per Approved IDE

1.7

2.2

2.1

1.8

1.8

 

 

 

 

 

 

 

 

Amendments under Review at End of Period d

8

7

6

11

11

 

 

 

 

 

 

 

 

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 01 - FY 04

 

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

 

 

 

 

 

Number Received

4,724

4,415

4,312

4,298

         
Number of Decisions

4,711

4,424

4,348

4,336

 

Average FDA Review Time (days)

20

19

19

19

         
Percent (%) OF Decisions Made within 30 Days

100

100

100

100

         
Number under Review at End of Period a

260

249

212

210

         
Number Overdue at End of Period

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 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

 

 

 

 

 

 

 

 

Number Originals Received

4,248

4,320

4,247

3,635

3,110

 

Number of Decisions

 

 

 

 

 

 

Substantially Equivalent

3,428

3,667

3,522

3,460

2,988

 

Not Substantially Equivalent

46

69

88

114

88

 

Other a

676

640

522

343

300

 

Total

4,150

4,376

4,132

3,917

3,376

 

Percent (%) Not Substantially Equivalent b

1.3

1.8

2.4

3.2

2.9

 

Average Review Time (Days)

 

 

 

 

 

 

FDA Time c

75

79

76

74

75

 

Total Time d

96

100

96

100

103

 

Median Review Time (Days)

 

 

 

 

 

 

FDA Time c

68

70

65

61

62

 

Total Time d

72

74

72

70

72

 

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

 

 

 

 

 

FDA Time e

100

100

99

100

100

 

Total Time d

69

69

69

65

64

 

Number under Review at End of Period f

 

 

 

 

 

 

Active g

934

935

1,015

652

561

 

(Active and Overdue)

0

0

0

0

0

 

On Hold h

382

337

376

441

378

 

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, and other miscellaneous action.
a duplicate, not a device, a general purpose article, exempted by regulation,
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 hange;
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 01 - FY 04

 

FY01

FY02

FY03

FY04 OIVD / ODE

FY04 ODE Only

 

Number of 510(k)s Received a

 

 

 

 

 

 

Traditional

3,370

3,352

3,157

1,991

1,667

 

Special

710

786

862

596

548

 

Abbreviated

174

184

206

89

75

 

Total Receipts

4,254

4,322

4,225

2,676

2,290

 

 

 

 

 

 

 

 

Actions on 510(k)s

 

 

 

 

 

 

Substantially Equivalent

3,574

3,566

3,597

2,118

1,817

 

Not Substantially Equivalent (%) b

61(1.7)

71(2)

109(2.9)

53(2.4)

41(2.2)

 

Other c

617

621

453

121

96

 

Total Actions

4,252

4,258

4,159

2,292

1,954

 

 

 

 

 

 

 

 

Average Cumulative Days for 510(k) Decisions

 

 

 

 

 

 

Excludes Withdrawals and Deletes

 

 

 

 

 

 

FDA Time from Receipt to Final Decision d

79

75

74

57

58

 

Total Time from Receipt to Final Decision e

99

91

95

70

71

 

All Decisions Including Withdrawals and Deletes  

 

 

   

 

FDA Time from Receipt to Final Decision d

78

74

73

56

57

 

Total Time from Receipt to Final Decision e

107

101

104

71

71

 

 

 

 

 

 

 

 

Number of Decisions (%) with 90 Days, Based on:

 

 

 

 

 

 

FDA Days from Receipt to First Action

4,245(100)

4,311(100)

4,212(100)

2,670(100)

2,285(100)

 

FDA Cumulative Days from Receipt to

 

 

 

 

 

 

Final Decisions

3,264(77)

3,377(78)

3,222(76)

2, 015(75)

1,712(75)

 

Total Cumulative Days from Receipt to

 

 

 

 

 

 

Final Decisions e

2,889(68)

3,018(70)

2,848(67)

1,779(66)

1,517(66)

 

Average Number of FDA Cycles

 

 

 

 

 

 

from Receipt to Final Action

1.4

1.4

1.5

1.4

1.4

 

Percentile FDA (Total) Days from Receipt to Final Action

 

 

 

 

 

 

25th

31(35)

30(34)

29(30)

28(29)

28(29)

 

50th (Median)

70(77)

69(76)

64(74)

62(72)

62(73)

 

75th

90(145)

90(130)

90(146)

90(136)

91(139)

 

90th

162(237)

162(252)

168(270)

N/A(N/A)

N/A(N/A)

 

Number under Review as of 9/30/01

 

 

 

 

 

 

Active

2

17

19

126

117

 

Active and Overdue

0

0

0

0

0

 

On Hold

0

47

47

257

218

 

Total

2

64

66

383

335

 

Summary of 510(k) Receipt Cohort

 

 

 

 

 

 

Substantially Equivalent

3,574

3,566

3,597

2,118

1,817

 

Not Substantially Equivalent

61

71

109

53

41

 

Other

617

621

453

121

96

 

Under Review

2

17

19

126

117

 

On Hold

0

47

47

257

218

 

Total

4,254

4,322

4,225

2,676

2,290

 

*/ For each fiscal year, September 30, 2004 was used as the cutoff date. The FY03 cohort represents only receipts through June 30, 2004 (first nine months of the fiscal year).
a/ Includes Third Party 510(k)s: FY01 =107; FY02 = 127; FY03 = 190; FY04=182 (9 months)
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 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.