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FY 2000 ODE Annual Report - Part 3 – Key Performance Indices

Workload/Resources

Table 1. Major Submissions Received
Table 2. Major Submissions Completed

Premarket Approval Applications (PMAs)

Figure 1. Average Review Time for PMA Decision Cohort Approvals
Figure 2. Original Receipt Cohort PMAs Received and Filed
Figure 3. Receipt Cohort PMA Average Elapsed
Figure 4. Annual Receipts and Actions for PMA Supplement Decision Cohort
Figure 5. Average Review Time for PMA Supplements

Real-Time Review of PMA Supplements
Product Development Protocols (PDPs)
Modular PMA Review
Humanitarian Device Exemption (HDE) Applications
Investigational Device Exemptions (IDE)

Figure 6. Percentage of IDEs Approved on First Review Cycle

Premarket Notification (510(k)s)

Figure 7. Average 510(k) Review Time for Decision Cohort
Figure 8. Receipts and Actions for 510(k) Receipt Cohorts*
Figure 9. FDA Days from Receipt to Final Action for 510(k) Receipt Cohorts*

Third-Party Review of 510(k)s
Special 510(k)s
Abbreviated 510(k)s
Significant Medical Device Breakthroughs
Classification Actions
Automatic Evaluation of Class III Designation
Final Reclassification Actions
Class II Exemption Petitions
Final 515(b) Calls for PMAs

 

ODE is responsible for protecting the rights, safety and welfare of patients participating in clinical studies of significant risk medical device research and for evaluating the safety and effectiveness of medical devices before these devices enter the U.S. market place.

Following are the details of ODE’s review activities and performance for Fiscal Year 2000 (FY 00). Most of the data below can be found in the tables in Part 5 -- the Operational Summary section of this report. First, we present the major submissions received and completed. Next, we review the Premarket Approval Applications (PMAs) in terms of review time as well as volume. This same analysis is done for PMA supplements. The remainder of this section deals with Humanitarian Device Exemptions (HDEs), Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s).

Workload/Resources

During FY 00, ODE received a total of 16,919 submissions, compared to 16,812 in FY 99; 9,774 were major submissions compared to 9,792 last fiscal year [see Table 1]. Major submissions include: IDEs -- originals, amendments and supplements; PMAs -- originals and supplements; HDEs -- originals and supplements; and 510(k)s. Other submissions include PMA amendments and reports; master files; and 510(k) amendments and supplements.

Table 1. Major Submissions Received
FY 90 – FY 00

Type of
Submission


1990


1991


1992


1993


1994


1995


1996


1997


1998


1999


2000


Orig. PMAs


79


75


65


40


43


39


44


66


47


60


67
PMA Supp. 660 593 606 395 372 499 415 409 513 552 545
Orig. IDEs 252 213 229 241 171 214 253 297 322 304 311
IDE Amend.
288

283

297

320

254

210

219

223

226

275

240
IDE Supp. 3,043 3,647 3,644 3,668 3,020 3,171 3,189 3,776 4,277 4,127 4,388
510(k)s 5,831 5,770 6,509 6,288 6,434 6,056 5,297 5,049 4,623 4,458 4,202
Orig. HDE 0 0 0 0 0 0 0 4 8 12 11
HDE Supp. 0 0 0 0 0 0 0 0 0 4 10
  _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____
Total 10,153 10,581 11,350 10,952 10,293 10,189 9,417 9,824 10,016 9,792 9,774

On the decision side, ODE completed the processing of 9,994 major submissions, compared to 9,881 major submissions in FY 99. [See Table 2 for major submissions completed.]

Table 2. Major Submissions Completed
FY 90 - FY 00

Type of
Submission


1990


1991


1992


1993


1994


1995


1996


1997


1998


1999


2000


Orig. PMAs


47


27


12


24


26


27


43


48


46


45


43
PMA Supp. 700 479 394 354 385 435 462 401 421 437 474
Orig. IDEs 248 220 215 248 174 210 260 272 325 305 320
IDE Amend.
270

287

297

324

256

213

218

220

225

268

251
IDE Supp. 2,968 3,705 3,469 3,814 3,070 3,181 3,121 3,777 4,209 4,224 4,335
510(k)s 6,197 5,367 4,862 5,073 7,135 7,948 5,563 5,155 5,229 4,593 4,397
Orig. HDE 0 0 0 0 0 0 0 2 4 6 6
HDE Supp. 0 0 0 0 0 0 0 0 0 3 10
  _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____
Total 10,430 10,085 9,249 9,837 11,045 12,014 9,667 9,875 10,459 9,881 9,994

ODE ended the fiscal year with 359 employees. During the year, 27 full-time employees (12 scientific reviewers, 1 medical officer, 13 clericals and 1 program analyst) left through resignation or retirement. During FY 00, 52 new employees (30 scientific reviewers, 6 medical officers, 1 program analyst, 11 clericals, and 4 summer students) joined our office.

Premarket Approval Applications (PMAs)

[NOTE: In previous annual reports, the PMA data included data for Humanitarian Device Exemption (HDE) Applications. This annual report contains a separate section for HDEs (see page 19). We also added new statistical Tables 8, 9 and 10 that contain HDE data.]

ODE received 67 complete original PMAs (7 more than the number received in FY 99) and 55 modular submissions representing 48 PMA shells.

The total number of PMAs in inventory (active and on hold) at the end of this fiscal year decreased from 77 in FY 99 to 76. The number of active PMAs under review decreased at the end of FY 00 to 35 compared to 47 last year, and those on hold increased from 30 in FY 99 to 41 in FY 00. This means that we took action on more PMAs and thus reduced the number under active review. For the third consecutive year, there were no active and overdue PMAs at the end of the fiscal year.

The total number of PMA actions increased from 229 to 321 actions. These actions included 68 filing decisions, 173 review determinations, and 80 approval/approvable/not approvable decisions.

The 80 original PMA decisions were comprised of 43 approved PMAs, 33 approvable PMAs, and 4 not approvable PMAs. None of the 43 approvals were expedited PMAs. See Part 2 (INDUSTRY INFORMATION) for a complete list of PMA approvals.

Average FDA review time for original PMAs reaching approval increased from 149 days in FY 99 to 158 days in FY 00. The non-FDA component of review time increased from 26 days in FY 99 to 40 days this fiscal year. Thus, the total average review time increased to 198 days. Of greater significance to industry is the total elapsed time from submission to decision.

Figure 1. Average Review Time for PMA Decision Cohort Approvals

Figure 1. Average Review Time for PMA Decision Cohort Approvals

In FY 00, the total average elapsed time for PMA decision cohort performance decreased from 380 days in FY 99 to 362 days in FY 00. (Please refer to Table 4.)

Figure 2. Original Receipt Cohort PMAs Received and Filed

Figure 2. Original Receipt Cohort PMAs Received and Filed

Figure 3. Receipt Cohort PMA Average Elapsed
Time from Filing to Final Action

Figure 3. Receipt Cohort PMA Average Elapsed Time from Filing to Final Action

For the first 6 months of FY 00 for PMA receipt cohort performance, the average FDA days from filing to first action decreased from 145 in FY 99 to 139 days.

The average FDA (total) elapsed time to an approval or to a denial decreased from 244(293) in FY 99 to 164(214) days in FY 00. The median FDA (total) elapsed time to an approval or denial decision decreased from 240(269) in FY 99 to 178(211) days in FY 00. This means that all of the statistics of the PMA receipt cohort for FY 00 indicate that we are making decisions faster.

The number of PMA supplements received decreased from last year’s 552 to 545. There were 747 PMA supplement actions which is up from last year’s 608 total actions. These actions included 17 panel track PMA supplement filing decisions, 98 scientific review decisions, and 632 approval decisions.

Figure 4. Annual Receipts and Actions for PMA Supplement Decision Cohort

Figure 4. Annual Receipts and Actions for PMA Supplement Decision Cohort

For PMA supplements reaching final action, the average elapsed FDA review time increased from 92 days in FY 99 to 94 days in FY 00, and the total average elapsed time increased from 118 days to 122 days.

Figure 5. Average Review Time for PMA Supplements

Figure 5. Average Review Time for PMA Supplements

Just as in FY 97, FY 98 and FY 99, there were no PMA supplements active and overdue at the end of this fiscal year. The number of active supplements decreased to 98 in FY 00 from 158 in FY 99, while the number of supplements on hold increased from 69 to 84. This means that although we are receiving about the same number of PMA supplements, we are reaching final decisions on more, but we are taking an average of 3 extra days for the decisions.

For the first 6 months of FY 00 for PMA supplements receipt cohort performance, the first action and final action as follows. The average FDA days from filing to first decision decreased from 74 in FY 99 to 67 days in FY 00. The average FDA (total) elapsed time to an approval or denial decreased from 79(95) in FY 99 to 66(76) in FY 00. The median FDA (total) elapsed time to an approval or denial remained the same from 35(47) in FY 99 to 35(43) days in FY 00.

Real-Time Review of PMA Supplements

A total of 146 requests were received and processed for real time PMA supplements in FY 00 which represents 27% of all supplements received. Of those submissions, 134 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference. The majority of these applications were reviewed in DCRND (54%) followed by DGRD (23%), DOD (11%), DRAERD (8%), DDIGD (2%) and DCLD (1%). Overall, average review time from "receipt" to first action (approvable, not approvable or approval order) was 34 days, and was 38 days from receipt to approval.

Product Development Protocols (PDPs)

Two PDPs have been approved in FY 00, and reports are being received on their progress for the clinical study. No original Notices of Completion were declared complete. In addition, five "Real Time" supplements, and three routine PDP supplements were approved. Note that a PDP that has been declared complete is considered to have an approved PMA. ODE continues to encourage the use of the PDP process and will work with the interested applicants to fully evaluate their PMA options.

Modular PMA Review

ODE received a total of 48 PMA shells and 55 modules. A total of 17 modules were found to be acceptable while 12 received deficiency letters. A number of modules were rolled into PMA review during FY 00 because they were under review or on hold at the time the PMA was received. Applicants with modular submissions that were under review or deficient when the PMA was received continued to receive feedback under the PMA for those modules. Review times for PMAs that had modular submissions were approximately half that for traditional PMAs. However, this is based on a small number of submissions achieving PMA approval since modular review was implemented. A tracking system with modular PMA query capability became available during FY 99.

Humanitarian Device Exemption (HDE) Applications

ODE received 11 original HDEs, 1 less than the number received in FY 99. The total number of original HDE actions decreased from 37 in FY 99 to 36 in FY 00. These actions included 12 filing decisions, 16 review determinations, 7 approval decisions and 1 other final decision.

A total of 8 first actions were made this fiscal year, a decrease from 13 made last year. The average time from filing to first action decreased from 87 days in FY 99 to 61 days in FY 00.

One hundred percent of the first actions made in FY 00 occurred within 75 days.

The 7 approval decisions were comprised of 6 approved HDEs and 1 approvable HDE.

In FY 00, the average elapsed time (from filing to final approval) for original HDEs was 216 days, an increase from 163 days in FY 99. The average FDA time was 112 days, a decrease from 113 days in FY 99. The average non-FDA time was 104 days, a significant increase from 50 days last year.

The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 10, the same as last fiscal year. Of these, 2 were under review and 8 were on hold. There was no active HDEs that were overdue at the end of the fiscal year.

The number of HDE supplements received increased from 4 in FY 99 to 10 in FY 00. There were 11 HDE supplement actions in FY 00, up from 7 in FY 99. These actions included 10 approval decisions and 1 not approvable decision.

A total of 10 first actions for HDE supplements were made this fiscal year, an increase from 4 last year. The average time from filing to first action decrease from 57 days in FY 99 to 44 days in FY 00. One hundred percent of the first actions were made within 75 days.

The average elapsed time (from filing to final approval) for HDE supplements decreased from 94 days in FY 99 to 76 days in FY 00. The average FDA time decreased from 70 days in FY 99 to 43 days in FY 00. Non-FDA time increased from 24 days in FY 99 to 33 days in FY 00.

The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 1, the same as last fiscal year.

Investigational Device Exemptions (IDE)

During FY 00, ODE reviewed 244 pre-IDEs. Based on these reviews, guidance for the pre-original IDE submissions were provided through meetings with the sponsors, letters, fax, or by phone phone.

ODE received 311 original IDEs, an increase from 304 received in FY 99. There were 320 decisions made on original IDEs, an increase from 305 last year.

Ninety-nine percent of all original IDE decisions were issued within 30 days in FY 00. The average review time was 28 days.

Figure 6. Percentage of IDEs Approved on First Review Cycle*

Figure 6. Percentage of IDEs Approved on First Review Cycle*

*Based on those IDEs complete enough to permit substantial review.

Of the IDEs which were complete enough to support substantive review, the percentage of IDEs approved on the first review cycle increased from 68% in FY 99 to 76% in FY 00.

During this fiscal year, 240 IDE amendments were received. Decisions were made on 251 amendments: 107 approvals (43%); 34 disapprovals (13%); and 110 other administrative actions (44%). One hundred percent of these decisions were made within 30 days.

It took an average total time of 136 days to approve IDEs that were initially disapproved, down from 145 days in FY 99. This average approval time consisted of 70 days for FDA time, up from 57 days last year, and 66 days for non-FDA time, down from 88 days in FY 99.

ODE received 4,388 IDE supplements during FY 00. There were no overdue supplements at the end of the year, and the percentage of supplements reviewed within the 30-day statutory timeframe was 100 percent in FY 00. The average review time for IDE supplements stayed the same at 20 days.

Premarket Notification (510(k)s)

ODE received 4,202 original 510(k)s, as well as 1,742 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 2,953 510(k) amendments (additional information received while the 510(k) is under review, the receipt of which does not affect the review clock).

The total average review time remained at 102 days in FY 00, and the average FDA review time was 77 days, down from 80 days in FY 99. The median review time, i.e., the time it took to review 50% of the 510(k)s, has been falling from a high of 164 days in FY 93 to a current low of 72 days in FY 00.

Figure 7. Average 510(k) Review Time for Decision Cohort

 

Figure 7. Average 510(k) Review Time for Decision Cohort

There were 1,220 510(k)s in inventory (those under active review or on hold) at the end of this fiscal year, which is 184 less than the 1,404 in FY 99’s end-of-year inventory. The number on hold decreased from 461 at the end of FY 99 to 370. Most important, for the fifth consecutive fiscal year there was no 510(k)s active and overdue at the end of the reporting period.

For the first 9 months of FY 00 for receipt cohort performance, the FDA time from receipt to final decision decreased to 60 days compared to 66 days for the first 9 months in FY 99.

Figure 8. Receipts and Actions for 510(k) Receipt Cohorts*

Figure 8. Receipts and Actions for 510(k) Receipt Cohorts*

*Cut off Date of 8/30/00 for all receipt cohorts.
**12 months projection based on first 9 months of receipts.

For the first 9 months of FY 00 for receipt cohort performance, the total time from receipt to final decision decreased to 75 days compared to 77 days for the first 9 months in FY 99.

Figure 9. FDA Days from Receipt to Final Action for 510(k) Receipt Cohorts*

Figure 9. FDA Days from Receipt to Final Action for 510(k) Receipt Cohorts*

*Cut Off Date as of 9/30/00 for all receipt cohorts.
**For the first 9 months of FY 00. 90th percentile data not available for FY 00.

Third-Party Review of 510(k)s

During FY 00, ODE received 47 510(k)s reviewed by third-party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. This is a small percentage of all 510(k)s that were eligible for third-party review, but is a 47% increase over the number of such submissions received by ODE last fiscal year. ODE made final decisions on 46 "third-party" 510(k)s in FY 00, an increase from the 29 final decisions in FY 99. The average total elapsed time from a third party’s receipt of a 510(k) to ODE’s issuance of a substantial equivalence decision was 68 days, as compared to the average total elapsed time of 99 days for ODE’s decision on comparable 510(k)s that did not have a third-party review.

In June 2000, to encourage greater industry use of Accredited Persons, the Center expanded the list of Class I and Class II devices that are eligible for review from 154 devices to 211 devices. In the Federal Register on July 18, 2000 (65 FR 44540), the Center also proposed an expansion pilot that would permit third-party review of a greatly expanded list of devices. The pilot would allow-subject to certain specified conditions-third-party review of Class II devices for which device-specific guidance does not exist.

Until now, device-specific guidance had existed for each Class II device that is eligible for third-party review. The Federal Register notice established a 45-day public comment period, which ended September 1, 2000. The Center has reviewed the public comments and intends to finalize the proposal in FY 01. Information on the expansion pilot is available on the Center’s third party web page.

Special 510(k)s

From October 1, 1999 to September 30, 2000 ODE received 615 Special 510(k)s out of the 4,202 total number of 510(k)s received, and 583 have received final decisions with the average FDA review time of 27 days and the average total time of 32 days, and 551 were found substantially equivalent and the remaining 32 had other decisions such as withdrawn or deleted.

Abbreviated 510(k)s

During the same timeframe ODE received 150 Abbreviated 510(k)s out of the 4,202 total number of 510(k)s received. One hundred eighteen received final decisions (104 substantially equivalent and 12 other decisions, and 2 NSEs) with a FDA average review time of 83 days and total time of 103 days. None of the Abbreviated 510(k)s went over 90 days.

Significant Medical Device Breakthroughs

During FY 00, ODE approved 15 PMAs and cleared 25 510(k)s that represented significant medical device breakthroughs. See INDUSTRY INFORMATION for a complete listing.

Classification Actions

  • Published a proposed rule in the Federal Register on October 1, 1999, classifying the subcutaneous, implanted, intravascular infusion port and catheter and the percutaneous, implanted, long-term intravascular catheter into Class II.
  • Published a final rule in the Federal Register on October 5, 1999, classifying the nonresorbable gauze/sponge for external use, the hydrophylic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into Class I.
  • Published a final rule in the Federal Register on May 18, 2000, classifying female condoms into Class III.
  • Published a final rule in the Federal Register on June 8, 2000, classifying liquid chemical sterilants/high level disinfectants into Class II and general-purpose disinfectants into Class I.
  • Published a final rule in the Federal Register on June 13, 2000, classifying the subcutaneous, implanted, intravascular infusion port and catheter and the percutaneous, implanted, long-term intravascular catheter into Class II.

Automatic Evaluation of Class III Designation

  • Published a final rule in the Federal Register on March 3, 2000, classifying the nitric oxide administration apparatus, nitric oxide analyzer, and the nitrogen dioxide analyzer into Class II.
  • Published a final rule in the Federal Register on March 29, 2000, classifying the biotinidase test system into Class II.
  • Published a final rule in the Federal Register on June 23, 2000, classifying devices to relieve upper airway obstruction into Class II.
  • Published a final rule in the Federal Register on August 2, 2000, classifying the clitoral engorgement device into Class II.
  • Published a final rule in the Federal Register on August 16, 2000, classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) in vitro diagnostic device into Class II.

Final Reclassification Actions

  • Published a final rule in the Federal Register on February 2, 2000, to reclassify the penile rigidity implant from Class III to Class II.
  • Published a final rule in the Federal Register on February 11, 2000, to reclassify and codify [Nd:YAG] laser for peripheral iridotomy from Class III to Class II.
  • Published a final rule in the Federal Register on March 31, 2000, to reclassify 28 Preamendments Class III Devices into Class II.
  • Published a final rule in the Federal Register on April 7, 2000, to reclassify OTC Test Sample Collection Systems for Drugs of Abuse Testing from Class III to Class I.
  • Published a final rule in the Federal Register on April 11, 2000, to reclassify cardiopulmonary bypass accessory equipment, goniometer device, and electrode cable devices from Class I to Class II.
  • Published a final rule in the Federal Register on April 13, 2000, to reclassify the stainless steel suture into Class II.
  • Published a final rule in the Federal Register on April 18, 2000, to reclassify the nonabsorable expanded polytetrafluoroethylene suture into Class II.
  • Published a final rule in the Federal Register on August 3, 2000, to reclassify the extracorporeal shock wave lithotripter from Class III to Class II.

Class II Exemption Petitions

  • Granted a Class II exemption on March 3, 2000, for vascular tunnelers submitted by Impra, Inc.

Final 515(b) Calls for PMAs

  • Published a final rule in the Federal Register on April 12, 2000, Effective Date of Requirement for Premarket Approval of the penile inflatable implant.
  • Published a final rule in the Federal Register on April 13, 2000, Effective Date of Requirement for Premarket Approval for three Preamendment Class III Devices (lung water monitor, powered vaginal muscle stimulator, and stair-climbing wheelchair).
  • Published a final rule in the Federal Register on July 5, 2000, Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and Gynecological Device.
  • Published a final rule in the Federal Register on September 26, 2000, Effective Date of Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device.