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FY 2000 ODE Annual Report - Part 5 – 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. HDE Submissions Received FY97 – FY00
Table 9. Original HDE Decision Cohort Performance FY97 – FY00

[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 14) and 2 (page 15) for general summary of major submissions received and completed.

Table 3. PMA/HDE/IDE/510(k) Submissions Received
FY 96 - FY 00

Type of Submission	Number Received
	FY 96	FY 97	FY 98	FY 99	FY 00
Premarket Approval (PMAs)
Original Applications	44	66	47	60	67
Amendments	883	829	710	767	978
Supplements	415	409	513	552	545
Amendments to Supplements	823	819	863	924	932
Reports for Orig. Applications	435	435	431	406	419
Reports for Supplements	24	2	0	0	0
Master Files	65	130	94	25	44
PMA Subtotal	2,689	2,690	2,658	2,734	2,985

Humanitarian Device Exemptions (HDEs)
Original Applications	0	4	8	12	11
Amendments	0	10	32	55	56
Supplements	0	0	0	4	10
Amendments to Supplements	0	0	0	3	12
Reports for Orig. Applications	0	0	0	6	9
Reports for Supplements	0	0	0	0	0
HDE Subtotal	0	14	40	80	98

Investigational Device Exemptions (IDEs)
Original Applications	253	297	322	304	311
Amendments	219	223	226	275	240
Supplements	3,189	3,776	4,277	4,127	4,388
IDE Subtotal	3,661	4,296	4,825	4,706	4,939

Premarket Notification (510(k)s)
Original Notifications	5,297	5,049	4,623	4,458	4,202
Supplements	3,246	2,785	2,023	1,872	1,742
Amendments	5,343	4,433	3,692	2,962	2,953
510(k) Subtotal	13,886	12,267	10,338	9,292	8,897

PMA/HDE/IDE/510(k) Total	20,236	19,267	17,861	16,812	16,919

Table 4. Original PMA Decision Cohort Performance*
FY 96 - FY 00

	FY 96	FY 97	FY 98	FY 99	FY 00
Number Received	44	0	55	72	67

PMA Actions Filing Decisions
Filed	45	58	51	65	64
Not Filed	17	16	10	7	4
Others	0	0	0	0	0
Filing Decision Subtotal	62	74	61	72	68
Scientific Review Decisions
Major Deficiencies	32	38	28	32	51
Minor Deficiencies	5	5	10	4	11
Other^a	97	138	105	105	111
Scientific Review Decisions Subtotal	134	181	143	141	173
Approval Decisions
Approvals	43	48	46	45	43
Approvable	27	14	7	7	33
Not Approvable	6	5	12	1	4
Denials	0	0	0	0	0
Approval Decision Subtotal	76	67	65	53	80
Total PMA Actions	272	322	269	266	321

Average Review Time (Days)
for Approvals^b
FDA	289	207	154	149	158
Non-FDA	55	40	37	26	40
Total	343	247	191	175	198

Average Elapsed Time (Days)
for Approvals^c
FDA	572	375	265	280	244
Non-FDA	214	122	108	100	119
Total	786	497	373	380	363

Number under Review at End of Period^d
Active^e	57	44	29	49	35
(Active and overdue)	(17)	(0)	(0)	(0)	(0)
On hold^f	39	41	41	38	41
Total	96	85	70	87	76

_____________________
*/	For FY 97, 98 and 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form and 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 the 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. Number of months based upon 30.4 day/month and rounded to one decimal point.
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 96 – FY 00

	FY 96		FY 97		FY 98		FY 99		FY 00
Original PMAs Received
PMAs	37		46		32		48		42
Expedited PMAs	5		10		6		7		4
Total	42		56		38		55		46

Filing Decisions^a
Filed	42		56		38		55		46
Not Filed	11		8		3		1		2
Number (%) of Filing/Not Filing
Decisions within 45 Days	26	(49)	51	(80)	30	(73)	44	(79)	39	(81)
Average Days/Cycle	67		39		44		42		40

Final Actions^b
Approvals	28		45		26		38		12
Denials	0		0		0		0		0
Other^c	18		22		15		9		8
Total	46		67		41		47		20

Filing to First Action Excluding withdrawals, conversions, etc.^d
Number Received and Filed	42		56		38		55		46
Number of First Actions	37		53		37		55		41
Average FDA Days	195		147		134		145		139
Median FDA Days	187		175		145		147		160
Number (%) of First Actions within 180 Days	18	(43)	41	(73)	32	(84)	43	(78)	41	(89)

Filing to First Action Including withdrawals, conversions, etc.^e
Number Received and Filed	42		56		38		55		46
Number of First Actions	42		56		38		55		46
Average FDA Days	228		146		134		145		140
Median FDA Days	183		173		141		147		152
Number (%) of First Actions within 180 Days	20	(48)	43	(77)	33	(87)	43	(78)	46	(100)

Filing to Final Actions Excluding withdrawals, conversions, etc.^f
Number Received and Filed	42		56		38		55		46
Number of Final Actions	30		45		28		35		15
Average FDA (Total) Elapsed Time	358	(514)	264	(346)	239	(321)	244	(293)	164	(214)
Median FDA (Total) Elapsed Time	329	(408)	217	(287)	198	(201)	240	(269)	178	(211)
Number (%) of Final Actions within 180 FDA Days	6	(20)	19	(42)	12	(43)	7	(20)	11	(73)
Number (%) of Final Actions within 180 Total Days	4	(13)	16	(36)	10	(36)	5	(14)	5	(33)

Filing to Final Action Including withdrawals, conversions, etc.^g
Number Received and Filed	42		56		38		55		46
Number of Final Actions	42		54		34		38		23
Average FDA (Total) Elapsed Time	378	(530)	257	(373)	224	(355)	245	(303)	161	(200)
Median FDA (Total) Elapsed Time	321	(420)	200	(315)	187	(252)	243	(271)	175	(195)
Number (%) of Final Actions within 180 FDA Days	8	(19)	23	(43)	17	(50)	8	(21)	18	(78)
Number (%) of Final Actions within 180 Total Days	6	(14)	18	(33)	11	(32)	5	(13)	10	(44)
Average Number of FDA Cycles from Receipt to Final Action Including
Withdrawals, conversions, etc ^b.	1.9		1.7		1.7		1.8		1.3

Percentile FDA Days from Filing to First Action^e
25^th	165		111		99		115		113
50^th (Median)	183		173		141		147		152
75^th	231		180		174		179		176
90^th	316		199		181		227		179

Percentile FDA Days from Filing to First Action^d
25^th	171		118		99		115		116
50^th (Median)	187		175		145		147		160
75^th	252		182		175		179		179
90^th	--		217		192		227		--

Percentile FDA (Total) Days from Filing to Final Action^g
25^th	233	(272)	165	(177)	141	(158)	185	(236)	120	(175)
50^th (Median)	321	(420)	200	(315)	187	(252)	243	(271)	175	(195)
75^th	432	(785)	382	(520)	289	(564)	284	(384)	181	(234)
90^th	712	(961)	440	(708)	392	(789)	341	(481)	202	(280)

Percentile FDA (Total) Days from Filing to Final Action^f
25^th	233	(272)	170	(177)	157	(158)	185	(234)	147	(178)
50^th (Median)	329	(408)	217	(287)	198	(201)	240	(269)	178	(211)
75^th	419	(779)	390	(520)	328	(387)	284	(372)	181	(240)
90^th	710	(987)	440	(680)	392	(801)	341	(437)	228	(280)

Number pending as of 9/30/00
Active	0		1		0		8		8
Active and Overdue	0		0		0		0		0
On hold^h	0		1		7		9		16
Total	0		2		7		17		24

Summary of PMA Receipt Cohort
Approved	28		45		26		38		12
Denied	0		0		0		0		0
Withdrawn	11		11		9		3		6
Other	7		11		6		6		2
Under Review	0		1		0		8		8
On Hold^h	0		1		7		9		16
Total	46		69		48		64		44

_____________________
*/	For each fiscal year, September 30, 2000 was used as the cutoff date. The FY 00 cohort represents only receipts through March 31, 2000 (first six months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
a/	The filing decision represents the count of applications with a filing date within the fiscal year as of the cutoff date. For example, a PMA that is considered complete at the time of submission would have a received date equal to the filed date. However, if the agency refuses to file the PMA, it is considered incomplete and the filed date becomes the date of the amendment that makes the submission complete for filing. Therefore, it is possible that the submission may be received in one fiscal year but not be considered a filed PMA until a subsequent fiscal year. For the purpose of receipt cohort reporting, PMAs are considered "received" based on the filing date rather than the receipt date.
b/	The final action analyses include actions as of the cutoff date for PMAs received within the fiscal year.
c/	Includes only actions that resulted in withdrawal, conversion, and other final actions 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 96 - FY 00

	FY 96	FY 97	FY 98	FY 99	FY 00
Number Received	415	409	513	556	545

PMA Supplement Actions Panel Track Filing Decisions^a
Filed	8	15	7	17	14
Not Filed	1	1	2	2	3
Other	0	0	0	0	0
Filing Decision Subtotal	9	16	9	19	17
Scientific Review Decisions
Major Deficiencies	9	3	4	12	14
Minor Deficiencies	1	1	2	0	1
Other^b	141	128	62	60	83
Scientific Review Decisions Subtotal	151	132	68	72	98
Approval Decisions
Panel track approvals^c	0	4	5	11	12
Nonpanel track approvals	462	397	416	426	462
Approvable	33	49	47	25	100
Not approvable	48	76	63	62	58
Approval Decision Subtotal	543	526	531	524	632
Total PMA Supplement Actions	703	674	608	615	747

Average Review Time (Days) for Approvals^d
FDA	146	100	82	76	76
Non-FDA	36	12	25	16	18
Total	182	112	107	92	94

Average Elapsed Time (Days) for Approvals^e
FDA	167	120	109	92	95
Non-FDA	49	23	43	26	27
Total	216	143	153	118	122

Number under Review at End of Period^f
Active^g	162	110	139	158	98
(Active and overdue)	(17)	(0)	(0)	(0)	(0)
On hold^h	74	80	57	70	84
Total	236	190	196	228	182

_________________
*/	For FY 97, 98 and 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form and 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 of the supplement, the status of the supplement as a special (changes being effected) or 30-day submission, and other miscellaneous administrative actions.
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. Number of months based upon 30.4 day/month and rounded to one decimal point.
e/	The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
f/	The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.
g/	FDA responsible for processing application.
h/	FDA’s processing of application officially suspended pending receipt of additional information from the applicant.

Table 7. PMA Supplement Receipt Cohort Performance*
FY 96 - FY 00

	FY 96		FY 97		FY 98		FY 99		FY 00
PMA Supplements Received
PMA Supplements	410		402		510		541		270
Expedited PMA Supplements	3		3		1		6		1
Total	413		405		511		547		271

Filing Decisions^a
Filed	4		6		9		15		7
Not Filed	0		1		1		0		1
Number of Filing/Not Filing
Decisions within 45 Days	3		5		9		10		7
Average Days/Cycle	45		45		42		45		43

PMA Supplement Final Actions^b
Approvals	379		369		427		441		200
Denials	0		0		0		0		0
Other^c	34		36		82		84		47

Filing to First Action Excluding withdrawals, conversions, etc.^d
Number Received and Filed	413		405		511		547		271
Number of First Actions	398		396		491		526		265
Average	122		90		82		74		67
Median	130		73		59		39		42
Number (%) of First Actions within 180 Days	311	(75)	350	(86)	433	(87)	475	(87)	262	(97)

Filing to First Action Including withdrawals, conversions, etc.^e

Number Received and Filed	413		405		511		547		271
Number of First Actions	411		405		509		544		271
Average	121		91		80		74		67
Median	126		70		49		37		39
Number (%) of First Actions within 180 Days	322	(78)	357	(88)	460	(90)	49	1(90)	268	(99)
Average Number of FDA Cycles from Receipt to Final Action Including
withdrawals, conversions, etc.^b	1.2		1.1		1.1		1.1		1.0

Filing to Final Action Excluding withdrawals, conversions, etc.^f
Number Received and Filed	413		405		511		547		271
Number of Final Actions	379		367		460		486		240
Average FDA (Total) Review Days	148	(185)	106	(129)	94	(118)	79	(95)	66	(76)
Median FDA (Total) Review Days	132	(150)	70	(83)	49	(66)	35	(47)	35	(43)
Number (%) of Final Actions Within 180 Days	259	(68)	304	(83)	374	(81)	420	(86)	234	(98)
Number (%) of Final Actions Within 180 Total Days	236	(62)	286	(78)	352	(77)	406	(84)	225	(94)

Filing to Final Action Including withdrawals, conversions, etc.^g
Number Received and Filed	413		405		511		547		271
Number of Final Actions	413		400		503		517		247
Average FDA (Total) Review Days	147	(202)	110	(147)	97	(131)	82	(102)	66	(75)
Median FDA (Total) Review Days	132	(156)	74	(94)	51	(69)	36	(50)	35	(43)
Number (%) of Final Actions Within 180 Days	284	(69)	324	(81)	490	(97)	447	(87)	241	(98)
Number (%) of Final Actions Within 180 Total Days	249	(60)	296	(74)	371	(74)	424	(82)	232	(94)

Percentile FDA Days from Filing to First Action^e
25^th	57		29		22		19		20
50^th (Median)	126		70		49		37		39
75^th	179		155		156		140		113
90^th	196		181		180		181		165

Percentile FDA Days from Filing to First Action^d
25^th	63		32		22		20		21
50^th (Median)	130		73		59		39		42
75^th	180		165		169		151		116
90^th	201		182		183		190		190

Percentile FDA (Total) Days from Filing to Final Action^g
25^th	63	(76)	33	(36)	22	(24)	20	(24)	18	(24)
50^th (Median)	132	(156)	74	(94)	51	(69)	36	(50)	35	(43)
75^th	187	(225)	169	(182)	175	(182)	147	(161)	109	(118)
90^th	296	(446)	216	(351)	212	(322)	190	(232)	165	(172)

Percentile FDA (Total) Days from Filing to Final Action^f
25^th	64	(76)	32	(35)	22	(25)	19	(24)	18	(24)
50^th (Median)	132	(150)	70	(83)	49	(66)	35	(47)	35	(43)
75^th	187	(210)	162	(179)	175	(179)	141	(152)	108	(117)
90^th	303	(379)	207	(313)	213	(281)	190	(214)	165	(174)

Number under review as of 9/30/00
Active	0		0		0		5		4
Active and Overdue	0		0		0		2		0
On hold^h	0		5		8		25		20
Total	0		5		8		32		24

Summary of PMA Supplement Receipt Cohort
Approved	379		369		427		441		200
Denied	0		0		0		0		0
Withdrawn	28		28		30		32		6
Other	6		8		52		52		41
Under Review	0		0		0		7		4
On Hold^h	0		5		8		25		20
Total	413		410		517		557		271

_____________________
*/	For each fiscal year, September 30, 2000 was used as the cutoff date. The FY 00 cohort represents only receipts through March 31, 2000 (first six 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 as 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 actions 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. HDE Submissions Received
FY97 – FY00

Type of Submission	Number Received
	FY 97	FY 98	FY 99	FY 00
Humanitarian Device
Exemption (HDE)
Original Applications	4	8	12	11
Amendments	10	32	55	56
Supplements	0	0	4	10
Amendments to Supplements	0	0	3	12
Reports for Orig. Applications	0	0	6	9
Reports for Supplements	0	0	0	0

HDE Subtotal	14	40	80	98

Table 9. Original HDE Decision Cohort Performance
FY97 – FY00

	FY 97	FY 98	FY 99	FY 00
Number Received	4	8	12	11
HDE Actions
Filing Decisions
Filed	2	9	10	8
Not Filed	0	1	1	4
Other^a	0	1	1	0
Filing Decision Subtotal	2	11	12	12

Scientific Review Decisions
Major Deficiencies	0	0	6	7
Minor Deficiencies	1	1	0	3
Other^b	0	0	4	6
Scientific Review Decisions Subtotal	1	1	10	16

Approval Decisions
Approvals	2	4	6	6
Approvable	0	0	5	1
Not Approvable	0	0	0	0
Denials	0	0	0	0
Approval Decision Subtotal	2	4	11	7
Other Final Decisions^c	0	2	4	1
Total HDE Actions	5	18	37	36

Filing to First Action^d
Number of First Actions	2	6	13	8
Average Number of FDA Days	68	139	87	61
Number of First Actions Within 75 Days	1	1	7	8

Average Elapsed Time (Days) for Approvals^e
FDA	108	152	113	112
Non-FDA	12	0	50	104
Total	120	152	163	216

Average Number of FDA Cycles from Receipt to Final Action^f	1	1.2	1.2	1.3
Number under Review at End of Period
Active	2	3	2	2

Active and overdue	0	0	0	0
On hold	0	1	8	8
Total	2	4	10	10

_________________
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 or conversion to another regulatory category.
d/	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.
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 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.
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.

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FY 2000 ODE Annual Report - Part 5 – Operational Summary - Section 1

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