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

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

Table 4. Original PMA Decision Cohort Performance

Table 5. Original PMA Receipt Cohort Performance

Table 6. PMA Supplement Decision Cohort Performance

Table 7. PMA Supplement Receipt Cohort Performance

Table 8. PMA Panel Track Supplement Receipt Cohort Performance

Table 9. HDE Submissions Received

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

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

TYPE OF SUBMISSION	NUMBER RECEIVED
	FY97	FY98	FY99	FY00	FY01
Premarket Approval (PMAs)
Original Applications	66	47	60	67	70
Amendments	829	710	767	978	753
Supplements	409	513	552	545	641
Amendments to Supplements	819	863	924	932	918
Reports for Original Applications	435	431	406	419	492
Reports for Supplements	2	0	0	0	0
Master Files	130	94	25	44	36
PMA Subtotal	2,690	2,658	2,734	2,985	2,910
Humanitarian Device Exemptions (HDEs)
Original Applications	4	8	12	11	5
Amendments	10	32	55	56	62
Supplements	0	0	4	10	16
Amendments to Supplements	0	0	3	12	8
Reports for Original Applications	0	0	6	9	24
Reports for Supplements	0	0	0	0	0
HDE Subtotal	14	40	80	98	115
Investigational Device Exemptions (IDEs)
Original Applications	297	322	304	311	284
Amendments	223	226	275	240	206
Supplements	3,776	4,277	4,127	4,388	4,811
IDE Subtotal	4,296	4,825	4,706	4,939	5,301
Premarket Notification (510(k)s)
Original Notifications	5,049	4,623	4,458	4,202	4,248
Supplements	2,785	2,023	1,872	1,742	1,579
Amendments	4,433	3,692	2,962	2,953	2,620
510(k) Subtotal	12,267	10,338	9,292	8,897	8,447
PMA/HDE/IDE/510(k) Total	19,267	17,861	16,812	16,919	16,773

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

	FY 97	FY 98	FY 99	FY 00	FY 01
Number Received	70	55	72	67	70
PMA Action
Filing Decisions
Filed	58	51	65	64	62
Not Filed	16	10	7	4	5
Others	0	0	0	0	0
Filing Decisions Subtotal	74	61	72	68	67
Scientific Review Decisions
Major Deficiencies	38	28	32	51	35
Minor Deficiencies	5	10	4	11	4
Other^a	138	105	105	111	95
Scientific Review Decisions Subtotals	181	143	141	173	134
Approval Decisions
Approvals	48	46	45	43	53
Approvable	14	7	7	33	18
Not Approvable	5	12	1	4	10
Denials	0	0	0	0	0
Approved Decision Subtotal	67	65	53	80	81
Total PMA Actions	322	269	266	321	282
Average Review Time (Days) for Approvals^b
FDA	207	154	149	158	129
Non-FDA	40	37	26	40	43
Total	247	191	175	198	172
Average Elapsed Time (Days) for Approvals^c
FDA	375	265	280	244	257
Non-FDA	122	108	100	119	154
Total	497	373	380	363	411
Number under Review at End of Period^d
Active	44	29	49	35	45
(Active and Overdue)	0	0	0	0	0
On Hold	41	41	38	41	35
Total	85	70	87	76	80

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

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

	FY97	FY98	FY99	FY00	FY01
Original PMAs Received
PMAs	46	32	48	60	28
Expedited PMAs	10	6	7	8	4
Total	56	38	55	68	32

Filing Decisions^a
Filed	56	38	55	68	32
Not Filed	8	3	1	3	1
Number (%) of Filing/Not Filing
Decisions within 45 Days	51(80)	30(73)	44(79)	54(76)	19(58)
Average Days/Cycle	39	44	42	40	45

Final Actions^b
Approvals	45	26	51	38	10
Denials	0	0	0	0	0
Other^c	23	19	10	14	3
Total	68	45	61	52	13

Filing to First Action Excluding withdrawals, conversions, etc.^d
Number Received and Filed	56	38	55	68	32
Number of First Actions	53	37	55	63	32
Average FDA Days	147	134	145	132	133
Median FDA Days	175	145	147	143	155
Number (%) of First Actions with 180 Days	41(77)	32(87)	43(78)	63(100)	31(97)

Filing to First Action Including withdrawals, conversions, etc.^e
Number Received and Filed	56	38	55	68	32
Number of First Actions	56	38	55	68	32
Average FDA Days	146	134	145	133	133
Median FDA Days	173	141	147	136	155
Number (%) of First Actions with 180 Days	43(77)	33(87)	43(78)	68(100)	31(97)

Filing to Final Action Excluding withdrawals, conversions, etc.^f
Number Received and Filed	56	38	55	68	32
Number of Final Actions	45	28	48	41	10
Average FDA (Total) Elapsed Time	284(377)	238(348)	267(382)	210(293)	172(203)
Median FDA (Total) Elapsed Time	237(297)	198(220)	251(344)	180(252)	177(188)
Number (%) of Final Actions with 180 FDA Days	18(40)	12(43)	8(17)	21(51)	8(80)
Number (%) of Final Actions with 180 Total Days	15(33)	10(36)	5(10)	7(17)	5(50)

Filing to Final Action Including withdrawals, conversions, etc.^g
Number Received and Filed	56	38	55	68	32
Number of Final Actions	55	36	52	54	10
Average FDA (Total) Elapsed Time	269(413)	220(404)	268(392)	199(283)	172(203)
Median FDA (Total) Elapsed Time	207(339)	180(288)	252(356)	180(248)	177(188)
Number (%) of Final Actions with 180 FDA Days	23(42)	19(53)	9(17)	32(59)	8(80)
Number (%) of Final Actions with 180 Total Days	17(31)	11(31)	5(10)	12(22)	5(50)

Average Number of FDA Cycles from Receipt to Final Action
Including withdrawals, conversions, etc.^b	1.8	1.7	2.0	1.5	1.2

Percentile FDA Days from Filing to First Action^d
25th	118	99	115	99	104
50th (Median)	175	145	147	143	155
75th	182	175	179	177	177
90th	217	192	227	180	179

Percentile FDA Days from Filing to First Action^e
25th	111	99	115	99	104
50th (Median)	173	141	147	136	155
75th	180	174	179	175	177
90th	199	181	227	179	179

Percentile FDA (Total) Days from Filing to Final Action^f
25th	175(178)	154(158)	254(252)	162(204)	163(177)
50th (Median)	237(297)	198(220)	251(344)	180(252)	177(188)
75th	416(545)	328(467)	322(491)	277(397)	179(212)
90th	443(708)	392(888)	404(637)	319(482)	215(266)

Percentile FDA (Total) Days from Filing to Final Action^g
25th	165(178)	141(168)	204(254)	151(195)	163(177)
50th (Median)	207(339)	180(288)	252(356)	180(248)	177(188)
75th	390(548)	285(645)	326(501)	249(381)	179(212)
90th	443(766)	392(888)	392(637)	311(482)	215(266)

Number Pending as of 9/30/01
Active	0	0	0	3	10
(Active and Overdue)	0	0	0	0	0
On Hold^h	1	3	3	12	15
Total	1	3	3	15	25

Summary of PMA Receipt Cohort
Approved	45	26	51	38	10
Denied	0	0	0	0	0
Withdrawn	11	10	4	10	3
Other	12	9	6	4	0
Under Review	0	0	0	3	10
On Hold^h	1	3	3	12	15
Total	69	48	64	67	38

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

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

	FY97	FY98	FY99	FY00	FY01

Number Received	409	513	556	545	641
PMA Supplement Actions
Panel Track Filing Decisions^a
Filed	15	7	17	14	10
Not Filed	1	2	2	3	4
Other	0	0	0	0	0
Filing Decision Subtotal	16	9	19	17	14

Scientific Review Decisions
Major Deficiencies	3	4	12	14	9
Minor Deficiencies	1	2	0	1	0
Other^b	128	62	60	83	78
Scientific Review Decisions Subtotal	132	68	72	98	87

Approval Decisions
Panel Track Approvals^c	4	5	11	12	10
Nonpanel Track Approvals	397	416	426	462	432
Approvable	49	47	25	100	100
Not Approvable	76	63	62	58	52
Approval Decision Subtotal	526	531	524	632	594

Total PMA Supplement Actions	674	608	615	747	695

Average Review Time (Days) for Approvals^d
FDA	100	82	76	76	71
Non-FDA	12	25	16	18	26
Total	112	107	92	94	97

Average Elapsed Time (Days) for Approvals^e
FDA	120	109	92	95	78
Non-FDA	23	43	26	27	32
Total	143	153	118	122	110

Number Under Review at End of Period^f
Active^g	110	139	158	98	152
(Active and Overdue)	0	0	0	0	(6)
On Hold^h	80	57	70	84	94
Total	190	196	228	182	246

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

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

	FY97	FY98	FY99	FY00	FY01
PMA Supplements Received
PMA Supplements	396	501	530	531	296
Expedited PMA Supplements	2	1	2	3	0
Panel Track PMA Supplements	6	9	11	10	6
Expedited Panel Track PMA Supplements	1	0	4	1	0
Total	405	511	547	545	302
PMA Supplement Final Actions^b
Approvals	365	421	440	412	195
Denials	0	0	0	0	0
Other^c	34	81	85	97	59

Filing to First Action Excluding withdrawals, conversions, etc.^a,^d
Number Received and Filed	398	502	532	534	296
Number of First Actions	389	482	513	517	281
Average FDA Days	89	81	72	63	71
Median FDA Days	71	57	36	37	48
Number (%) of First Actions within 180 Days	346(89)	436(91)	464(91)	505(98)	270(96)

Filing First Action Including withdrawals, conversions, etc.^e
Number Received and Filed	398	502	532	534	296
Number of First Actions	398	500	532	532	291
Average FDA Days	89	80	73	64	70
Median FDA Days	68	47	35	35	44
Number (%) of First Actions within 180 Days	353(89)	453(91)	481(90)	520(98)	280(96)

Filing to Final Action Excluding withdrawals, conversions, etc.^f
Number Received and Filed	398	502	532	534	296
Number of First Actions	363	455	486	485	243
Average FDA (Total) Review Days	103(125)	91(115)	75(102)	65(81)	65(72)
Median FDA (Total) Review Days	68(80)	46(65)	34(47)	32(40)	37(43)
Number (%) of Final Actions within 180 Days	304(84)	376(83)	424(87)	461(95)	235(97)
Number (%) of Final Actions within 180 Total Days	286(79)	352(77)	402(83)	437(90)	224(92)

Filing to Final Action Including withdrawals, conversions, etc.^g
Number Received and Filed	398	502	532	534	296
Number of First Actions	394	498	520	509	253
Average FDA (Total) Review Days	106(141)	94(129)	79(115)	67(85)	64(71)
Median FDA (Total) Review Days	72(93)	49(68)	36(51)	34(42)	37(43)
Number (%) of Final Actions within 180 Days	323(82)	411(83)	452(87)	484(95)	254(97)
Number (%) of Final Actions within 180 Total Days	296(75)	371(75)	420(81)	454(89)	234(93)
Average Number of FDA Cycles from Receipt to Final Action Including withdrawls, conversations, etc.^b	1.1	1.1	1.1	1.1	1.0
Percentile FDA Days from Filing to First Action^d
25th	29	22	19	21	26
50th (Median)	71	57	36	37	48
75th	162	169	147	113	127
90th	182	183	189	176	180
Percentile FDA Days from Filing to First Action^e
25th	29	22	19	20	26
50th (Median)	68	47	35	35	44
75th	151	155	135	109	123
90th	181	180	180	168	175
Percentile FDA Days from Filing to First Action^f
25th	30(35)	22(25)	18(24)	19(25)	25(27)
50th (Median)	68(80)	46(65)	34(47)	32(40)	37(43)
75th	155(177)	173(178)	132(152)	101(116)	101(116)
90th	206(287)	202(279)	189(232)	147(180)	166(177)
Percentile FDA Days from Filing to First Action^g
25th	32(36)	22(24)	19(25)	19(25)	25(25)
50th (Median)	72(93)	49(68)	36(51)	34(42)	37(42)
75th	169(180)	174(181)	140(163)	107(123)	99(123)
90th	210(347)	203(314)	190(254)	174(189)	166(189)

Number Pending as of 9/30/01
Active	0	0	2	2	19
(Active and Overdue)	0	0	0	0	(4)
On Hold^h	4	4	10	23	24
Total	4	4	12	25	43

Summary of PMA Supplement Receipt Cohort
Approved	365	421	440	412	195
Denied	0	0	0	0	0
Withdrawn	26	30	32	20	11
Other	8	51	53	77	48
Under Review	0	0	2	2	19
On Hold^h	4	4	10	23	24
Total	403	506	537	534	297

*/	For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through March 31, 2001 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a during which time PMA from its filing date until it receives final approval. Panel Track Supplement times are quantified in Table 8.
a/	Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/	The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
c/	Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/	The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final actions.
e/	The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/	The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/	The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/	"On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

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

	FY97	FY98	FY99	FY00	FY01
PMA Panel Track Supplements Received
Filing Decisions^a
Filed	6	9	15	11	6
Not Filed	1	1	0	1	0
Number of Filing/Not Filing Decisions within 45 Days	5	9	10	10	5
Average Days/Cycle	45	42	45	39	40

PMA Panel Track Supplement Final Actions^b
Approvals	5	9	13	6	3
Denials	0	0	0	0	0
Other^c	2	2	3	2	1

Filing to First Action Excluding withdrawals, conversions, etc.^d
Number Received and Filed	7	9	15	11	6
Number of First Actions	7	9	15	11	5
Average FDA Days	165	116	134	119	130
Median FDA Days	180	106	162	135	153
Number (%) of First Actions within 180 Days	4(57)	7(78)	13(87)	10(91)	5(100)

Filing First Action Including withdrawals, conversions, etc.^e
Number Received and Filed	7	9	15	11	6
Number of First Actions	7	9	15	11	5
Average FDA Days	165	116	134	119	130
Median FDA Days	180	106	162	135	153
Number (%) of First Actions within 180 Days	4(57)	7(78)	13(87)	10(91)	5(100)

Filing to Final Action Excluding withdrawals, conversions, etc.^f
Number Received and Filed	5	8	12	6	2
Number of First Actions	5	8	12	6	2
Average FDA (Total) Review Days	446(703)	287(343)	255(285)	214(231)	208(226)
Median FDA (Total) Review Days	454(454)	237(269)	192(239)	214(248)	208(226)
Number (%) of Final Actions within 180 Days	0(0)	1(13)	5(42)	2(33)	1(50)
Number (%) of Final Actions within 180 Total Days	0(0)	0(0)	4(33)	2(33)	1(50)

Filing to Final Action Including withdrawals, conversions, etc.^g
Number Received and Filed	7	9	13	8	3
Number of First Actions	7	9	13	8	3
Average FDA (Total) Review Days	407(692)	275(374)	253(281)	235(277)	198(226)
Median FDA (Total) Review Days	454(454)	232(296)	199(235)	214(291)	179(226)
Number (%) of Final Actions within 180 Days	1(14)	2(22)	6(46)	3(38)	2(67)
Number (%) of Final Actions within 180 Total Days	0(0)	0(0)	4(31)	2(25)	1(33)
Average Number of FDA Cycles from Receipt to Final
Action Including withdrawals, conversions, etc.^b	2.3	1.8	1.8	1.5	1.3

Percentile FDA Days from Filing to First Action^d
25th	143	87	84	88	86
50th (Median)	180	106	162	135	153
75th	190	175	179	157	179
90th	196	227	185	175	---

Percentile FDA Days from Filing to First Action^e
25th	143	87	84	88	86
50th (Median)	180	106	162	135	153
75th	190	175	179	157	179
90th	196	227	185	175	---

Percentile FDA (Total) Days from Filing to Final Action^f
25th	190(209)	229(235)	178(179)	144(144)	168(168)
50th (Median)	454(454)	237(269)	192(239)	214(248)	208(226)
75th	641(925)	355(474)	373(373)	266(295)	248(283)
90th	760(1736)	484(560)	433(488)	313(313)	248(283)

Percentile FDA (Total) Days from Filing to Final Action^g
25th	186(209)	227(237)	179(179)	140(177)	168(168)
50th (Median)	454(454)	232(296)	199(235)	214(291)	179(226)
75th	641(925)	261(484)	361(361)	290(317)	248(283)
90th	760(1736)	484(621)	433(488)	458(510)	248(283)

Number Pending as of 9/30/01
Active	0	0	2	2	4
(Active and Overdue)	0	0	0	0	(1)
On Hold^h	4	4	10	23	2
Total	4	4	12	25	6

Summary of PMA Supplement Receipt Cohort
Approved	5	9	13	6	3
Denied	0	0	0	0	0
Withdrawn	2	1	3	2	1
Other	0	1	0	0	0
Under Review	0	0	1	1	4
On Hold^h	0	0	3	3	2
Total	7	11	20	12	10

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

Table 9. HDE Submissions Received
FY97 — FY01

TYPE OF SUBMISSION	NUMBER RECEIVED
	FY97	FY98	FY99	FY00	FY01
Humanitarian Device Exemptions (HDEs)
Original Applications	4	8	12	11	5
Amendments	10	32	55	56	62
Supplements	0	0	4	10	16
Amendments to Supplements	0	0	3	12	8
Reports for Original Applications	0	0	6	9	24
Reports for Supplements	0	0	0	0	0
HDE Subtotal	14	40	80	98	115

About FDA

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FDA Organization

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

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

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

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

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

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

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

Table 9. HDE Submissions Received
FY97 — FY01

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About FDA

Section Contents Menu

FDA Organization

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

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

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

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

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

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

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

Table 9. HDE Submissions Received FY97 — FY01

Links on this page:

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

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

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

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

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

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

Table 9. HDE Submissions Received
FY97 — FY01