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FY 2001 ODE Annual Report - Part 6 Operational Summary - Section 2

Table 10. Original HDE Decision Cohort Performance
Table 11. HDE Supplement Decision Cohort Performance
Table 12. Original IDEs
Table 13. IDE Amendments
Table 14. IDE Supplements
Table 15. 510(k) Decision Cohort Performance
Table 16. 510(k) Receipt Cohort Performance

Table 10. Original HDE Decision Cohort Performance
FY97 — FY01

	FY 97	FY 98	FY 99	FY 00	FY 01
Number Received	4	8	12	11	5
HDE Action
Filing Decisions
Filed	2	9	10	8	6
Not Filed	0	1	1	4	1
Others^a	0	1	1	0	0
Filing Decisions Subtotal	2	11	12	12	7
Scientific Review Decisions
Major Deficiencies	0	0	6	7	7
Minor Deficiencies	1	1	0	3	6
Other^b	0	0	4	6	2
Scientific Review Decisions Subtotals	1	1	10	16	15
Approval Decisions
Approvals	2	4	6	6	4
Approvable	0	0	5	1	0
Not Approvable	0	0	0	0	0
Denials	0	0	0	0	0
Approved Decision Subtotal	2	4	11	7	4
Other Final Decisions^c	0	2	4	1	4
Total HDE Actions	5	18	37	36	30

Filing to First Action^d
Number of First Actions	2	6	13	8	6
Average Number of FDA Days	68	139	87	61	42
Number of First Actions Within 75 Days	1	1	7	8	6
Average Elapsed Time (Days) for Approvals^c
FDA	108	152	113	112	143
Non-FDA	12	0	50	104	100
Total	120	152	163	216	243

Average Number of FDA Cycles from Receipt 1.0		1.2	1.2	1.3	1.9
to Final Action^f

Number under Review at End of Period
Active	2	3	2	2	1
Active and Overdue	0	0	0	0	0
On Hold	0	1	8	8	6
Total	2	4	10	10	7

a/	Includes 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
FY97 — FY01

	FY97	FY98	FY99	FY00	FY01

Number Received	0	0	4	10	16

HDE Supplement Actions

Scientific Review Decisions
Major Deficiencies	0	0	1	0	0
Minor Deficiencies	0	0	0	0	0
Other^a	0	0	2	0	1
Scientific Review Decisions Subtotal	0	0	3	0	1

Approval Decisions
Approvals	0	0	3	10	11
Approvable	0	0	1	0	0
Not Approvable	0	0	0	1	1
Denials	0	0	0	0	0
Approval Decision Subtotal	0	0	4	11	12
Other Final Decisions^b	0	0	0	0	1
Total HDE Actions	0	0	7	11	13

Filing to First Action^c
Number of First Actions	0	0	4	10	12
Average Number of FDA Days	0	0	57	44	52
Number of First Actions within 75 Days	0	0	4	10	8

Average Elapsed Time (Days) for Approvals^d
FDA	0	0	70	43	46
Non-FDA	0	0	24	33	0
Total	0	0	94	76	46

Average Number of FDA Cycles from
Receipt to Final Action^e	0.0	0.0	1.3	1.0	1.0

Number Under Review at End of Period^f
Active^g	0	0	0	0	4
(Active and Overdue)	0	0	0	0	0
On Hold^h	0	0	1	1	1
Total	0	0	1	1	5

a/	Includes actons that did not result in a final decision, such as GMP deficiency letter or an applicant-directed hold.
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 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 97 - FY 01

	FY97	FY98	FY99	FY00	FY01

Number Received	297	322	304	311	284

Number of Decisions
Approved	172	201	176	213	208
Not Approved	79	82	82	66	53
Other^a	21	42	47	41	23
Total	272	325	305	320	284

Percent (%) of Approvals Made during First
Review Cycle^b	69	71	68	76	80

Average FDA Review Time (days)	29	27	27	28	28

Percent (%) of Decisions Made within 30 Days	100	100	99	99	100

Number under Review at End of Period^c	32	29	28	19	18

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 97 - FY 01

	FY97	FY98	FY99	FY00	FY01

Amendments Received^a	223	226	275	240	206

Decisions on Amendments
Approved	101	94	97	107	73
Not Approved	25	36	42	34	39
Other^b	94	95	129	110	95
Total	220	225	268	251	207

Average FDA Review Time (days)	18	19	18	19	18

Percent (%) of Decisions Made within 30 Days	100	100	100	100	99

Average Approval Time (days) for IDEs with Amendments
FDA Time	61	55	57	70	59
Non-FDA Time	84	35	88	66	82
Total Time^c	145	90	145	136	141

Number of Amendments per Approved IDE	1.8	1.4	1.6	2.3	1.7

Amendments under Review at End of Period^d	12	13	19	9	8

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 97 - FY 01

	FY97	FY98	FY99	FY00	FY01

Number Received	3,776	4,277	4,127	4,388	4,811

Number of Decisions	3,777	4,209	4,224	4,335	4,803

Average FDA Review Time (days)	21	21	20	20	21

Percent (%) OF Decisions Made within 30 Days	100	100	100	100	100

Number under Review at End of Period^a	216	284	187	239	247

Number Overdue at End of Period	0	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 97 - FY 01

	FY97	FY98	FY99	FY00	FY01

Number Originals Received	5,049	4,623	4,458	4,202	4,248
Number of Decisions
Substantially Equivalent	4,405	3,824	3,652	3,567	3,428
Not Substantially Equivalent	57	65	66	52	46
Other^a	693	1,340	875	778	676
Total	5,155	5,229	4,593	4,397	4,150

Percent (%) Not Substantially Equivalent^b	1.3	1.7	1.8	1.4	1.3

Average Review Time (Days)
FDA Time^c	97	89	80	77	75
Total Time^d	130	114	102	102	96

Median Review Time (Days)
FDA Time^c	81	81	71	68	68
Total Time^d	85	83	76	72	72

Percent (%) of Decisions made within 90 Days, based on
FDA Time^e	95	97	99	100	100
Total Time^d	58	59	66	66	69

Number under Review at End of Period^f
Active^g	1,287	1,057	943	850	934
(Active and Overdue)	0	0	0	0	0
On Hold^h	865	487	461	370	382
Total	2,152	1,544	1,404	1,220	1,316

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, a duplicate, not a device, a transitional device, regulated by CBER, a general purpose article, exempted by regulation, and other miscellaneous action.
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 change; 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 97 - FY 01

	FY97	FY98	FY99	FY00	FY01
Number of 510(k)s Received^a
Traditional	5,059	4,528	3,985	3,471	2,392
Special	0	80	396	584	522
Abbreviated	0	21	85	149	137
Total Receipts	5,059	4,629	4,466	4,204	3,051

Actions on 510(k)s
Substantially Equivalent	4,150	3,573	3,603	3,397	2,246
Not Substantially Equivalent (%)^b	53(1.3)	70(1.9)	63(1.7)	40(1.2)	27(1.2)
Other^c	856	986	798	718	340
Total Actions	5,059	4,629	4,464	4,155	2,613

Average Cumulative Days for 510(k) Decisions
Excludes Withdrawals and Deletes
FDA Time from Receipt to Final Decision^d	91	82	81	73	65
Total Time from Receipt to Final Decision^e	116	104	104	91	74
All Decisions Including Withdrawals and Deletes
FDA Time from Receipt to Final Decision^d	89	81	79	72	64
Total Time from Receipt to Final Decision^e	134	118	114	99	75

Number of Decisions (%) with 90 Days, Based on:
FDA Days from Receipt to First Action	4,968(98)	4,612(100)	4,453(100)	4,197(100)	3,047(100)
FDA Cumulative Days from Receipt to
Final Decisions	3,558(70)	3,529(76)	3,372(76)	3,364(80)	2,264(74)
Total Cumulative Days from Receipt to
Final Decisions^e	3,025(60)	3,025(65)	2,938(66)	2,917(69)	2,074(68)
Average Number of FDA Cycles
from Receipt to Final Action	1.5	1.4	1.4	1.4	1.3

Percentile FDA (Total) Days from Receipt to Final Action
25th	51(57)	47(51)	41(45)	35(41)	32(36)
50th (Median)	80(86)	75(83)	71(78)	65(73)	71(77)
75th	106(175)	90(149)	90(147)	89(126)	96(145)
90th	172(312)	160(256)	160(263)	155(238)	N/A(N/A)

Number under Review as of 9/30/01
Active	0	0	1	17	169
Active and Overdue	0	0	0	0	0
On Hold	0	0	1	32	269
Total	0	0	2	49	438
Summary of 510(k) Receipt Cohort
Substantially Equivalent	4,150	3,573	3,603	3,397	2,246
Not Substantially Equivalent	53	70	63	40	27
Other	856	986	798	718	340
Under Review	0	0	1	17	169
On Hold	0	0	1	32	269
Total	5,059	4,629	4,466	4,204	3,051

*/	For each fiscal year, September 30, 2001 was used as the cutoff date. The FY01 cohort represents only receipts through June 30, 2001 (first nine months of the fiscal year).
a/	Includes Third Party 510(k)s: FY97 = 14; FY98 = 18; FY99 = 32; FY00 = 47; FY01 = 70
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, delted due to lack of response of response, a duplicate, not a device, a transitional device, regulated by CBER, 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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FDA Organization

FY 2001 ODE Annual Report - Part 6 Operational Summary - Section 2

Table 10. Original HDE Decision Cohort Performance
FY97 — FY01

Table 11. HDE Supplement Decision Cohort Performance
FY97 — FY01

Table 12. Original IDEs
FY 97 - FY 01

Table 13. IDE Amendments
FY 97 - FY 01

Table 14. IDE Supplements
FY 97 - FY 01

Table 15. 510(k) Decision Cohort Performance
FY 97 - FY 01

Table 16. 510(k) Receipt Cohort Performance ^*
FY 97 - FY 01

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About FDA

Section Contents Menu

FDA Organization

FY 2001 ODE Annual Report - Part 6 Operational Summary - Section 2

Table 10. Original HDE Decision Cohort PerformanceFY97 — FY01

Table 11. HDE Supplement Decision Cohort PerformanceFY97 — FY01

Table 12. Original IDEsFY 97 - FY 01

Table 13. IDE AmendmentsFY 97 - FY 01

Table 14. IDE SupplementsFY 97 - FY 01

Table 15. 510(k) Decision Cohort PerformanceFY 97 - FY 01

Table 16. 510(k) Receipt Cohort Performance *FY 97 - FY 01

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Table 10. Original HDE Decision Cohort Performance
FY97 — FY01

Table 11. HDE Supplement Decision Cohort Performance
FY97 — FY01

Table 12. Original IDEs
FY 97 - FY 01

Table 13. IDE Amendments
FY 97 - FY 01

Table 14. IDE Supplements
FY 97 - FY 01

Table 15. 510(k) Decision Cohort Performance
FY 97 - FY 01

Table 16. 510(k) Receipt Cohort Performance ^*
FY 97 - FY 01