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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

Expedited PMAs

Total

Filing Decisions a

Filed

Not Filed

Number (%) of Filing/Not Filing Decisions

within 45 Days

47(66)

31(76)

32(71)

25(76)

16(73)

Average Days/Cycle

Final Actions b

Approvals

Denials

Other c

Total

Filing to First Action Excluding withdrawals, conversions, etc. d

Number Received and Filed

Number of First Actions

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

Number of First Actions

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

Number of Final Actions

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

Number of Final Actions

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

50th (Median)

133

143

129

110

111

75th

176

174

145

157

90th

179

180

178

176

178

Percentile FDA Days from Filing to First Action e

25 th

105

108

50th (Median)

133

143

129

110

111

75th

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)

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)

Active

(Active and Overdue)

(1)

(0)

(1)

On Hold h

Total

Approved

Denied

Withdrawn

Other

Under Review

On Hold h

Total

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

50th (Median)

75 th

127

137

117

90 th

180

179

178

175

174

Percentile FDA Days from Filing to First Action e

25 th

50th (Median)

75 th

120

130

101

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)

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)

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

(Active and Overdue)

(0)

(2)

On Hold h

Total

Summary of PMA Supplement Receipt Cohort

Approved

472

500

481

206

191

Denied

Withdrawn

Other

111

127

Under Review

On Hold h

Total

624

625

659

306

280

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

119

126

50th (Median)

135

158

109

148

75 th

174

145

169

90 th

180

191

179

169

Percentile FDA Days from Filing to First Action e

25 th

119

126

50th (Median)

135

158

109

148

75 th

174

145

169

90 th

180

191

179

169

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

25 th

174(174)

171(216)

206(207)

169(169)

50th (Median)

221(276)

200(230)

233(254)

169(169)

75 th

288(539)

334(415)

270(339)

169(169)

90 th

313(555)

385(494)

305(404)

169(169)

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

25 th

175(175)

170(216)

232(234)

169(169)

50 th (Median)

221(276)

200(234)

234(273)

169(169)

75 th

288(539)

334(438)

244(404)

169(169)

90 th

343(664)

385(546)

305(489)

169(169)

Number Pending as of 9/30/02

Active

(Active and Overdue)

(0)

On Hold h

Total

Summary of PMA Supplement Receipt Cohort

Approved

Denied

Withdrawn

Other

Under Review

On Hold h

Total

*/ 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

	FY01	FY02	FY03	FY04 OIVD / ODE	FY04 ODE Only
TYPE OF SUBMISSION	NUMBER RECEIVED
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.

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FY 2004 ODE Annual Report - Part 7 - Operational Summary

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