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FY 2001 ODE Annual Report - Part 3 — Key Performance Indices

Resources

Workload

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 Time from Filing to Final Action
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

Proposed Reclassification Actions

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 2001 (FY 01). Most of the data discussed below can be found in the tables below and in Part 6 - OPERATIONAL SUMMARY. 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 part deals with Humanitarian Device Exemptions (HDEs), Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s).

Resources

ODE ended FY 2001 with 353 employees. During the year, ODE lost 25 full-time employees (18 scientific reviewers, 3 medical officers and 4 clericals) through resignation, reassignment or retirement and added 21 new employees (8 scientific reviewers, 7 medical officers, 1 program analyst and 5 clericals). Through our Intern Program, ODE also had the services of 6 part-time students and professionals.

Workload

During FY 01, ODE received 10,281 major submissions compared to 9,774 major submissions in FY 00. [See Table 1 for a breakdown of major submissions received.]

Table 1. Major Submissions Received
FY 91 — FY 01

  TYPE OF SUBMISSION

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

 
                         
  Original PMAs

75

65

40

43

39

44

66

47

60

67

70

 
  PMA
Supplements

593

606

395

372

499

415

409

513

552

545

641

 
  Original IDEs

213

229

241

171

214

253

297

322

304

311

284

 
  IDE Amendments

283

297

320

254

210

219

223

226

275

240

206

 
  IDE Supplements

3,647

3,644

3,668

3,020

3,171

3,189

3,776

4,277

4,127

4,388

4,811

 
  510(k)s

5,770

6,509

6,288

6,434

6,056

5,297

5,049

4,623

4,458

4,202

4,248

 
  Original HDE

0

0

0

0

0

0

4

8

12

11

5

 
  HDE Supplements

0

0

0

0

0

0

0

0

4

10

16

 
  Total

10,581

11,350

10,952

10,293

10,189

9,417

9,824

10,016

9,792

9,774

10,281

 

On the decision side, ODE completed the processing of 9,954 major submissions, compared to 9,994 major submissions in FY 00. [See Table 2 for major submissions completed.]

Table 2. Major Submissions Completed
FY 91 - FY 01

TYPE OF SUBMISSION

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

 
                         
  Original PMAs

27

12

24

26

27

43

48

46

45

43

53

 
  PMA Supplements

479

394

354

385

435

462

401

421

437

474

442

 
  Original IDEs

220

215

248

174

210

260

272

325

305

320

284

 
  IDE Amendments

287

297

324

256

213

218

220

225

268

251

207

 
  IDE Supplements

3,705

3,469

3,814

3,070

3,181

3,121

3,777

4,209

4,224

4,335

4,803

 
  510(k)s

5,367

4,862

5,073

7,135

7,948

5,563

5,155

5,229

4,593

4,397

4,150

 
  Original HDE

0

0

0

0

0

0

2

4

6

6

4

 
  HDE Supplements

0

0

0

0

0

0

0

0

3

10

11

 
  Total

10,085

9,249

9,837

11,045

12,014

9,667

9,875

10,459

9,881

9,994

9,954

 

Premarket Approval Applications (PMAs)

ODE received 70 original PMAs (3 more than the number received in FY 00). The total number of PMAs in inventory (active and on hold) at the end of this fiscal year increased from 76 in FY 00 to 80. The number of active PMAs under review increased at the end of FY 01 to 45 compared to 35 last year, and those on hold decreased from 41 in FY 00 to 35 in FY 01. For the fifth consecutive year, there were no active and overdue PMAs at the end of the fiscal year.

The total number of PMA actions decreased from 321 to 282 actions. These actions included 67 filing decisions, 134 review determinations, and 81 approval/approvable/not approvable decisions.

The 81 original PMA decisions were comprised of 53 approved PMAs, 18 approvable PMAs, and 10 not approvable PMAs. Of the 53 approvals, 11 were expedited PMAs. See Part 2 (INDUSTRY INFORMATION) for a complete list of PMA approvals.

Average FDA review time for original PMAs reaching approval decreased from 158 days in FY 00 to 129 days in FY 01. The non-FDA component of review time increased from 40 days in FY 00 to 43 days this fiscal year. Thus, the total average review time decreased to 172 days from 198 days.

Figure 1. Average Review Time for PMA Decision Cohort Approvals

 

The Average Review Time for original PMA's decreased from 158 days in FY 00 to 129 days in FY 01

Of greater significance to industry is the total elapsed time from submission to decision.In FY 01, the total average elapsed time for PMA decision cohort performance increased from 363 days in FY 00 to 411 days in FY 01. (Please refer to Table 4.)

Figure 2. Original Receipt Cohort PMAs Received and Filed

Figure 2 shows in change in FY00 of 67 Received, 68 Filed, 3 not filed to in FY01 first six months of 70 received, 32 filed and 1 not filed
*First six months

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

Figure 3 - Shows PMA average elapsed time from filing to final action in FY00 had FDA time of 210 days and non-FDA time of 83 days. This changed in the first 6 months of FY01 to 172 days of FDA time
*First six months

For the first 6 months of FY 01 for PMA receipt cohort performance, the average FDA days from filing to first action increased from 132 in FY 00 to 133 days.

The average FDA (total) elapsed time to an approval or to a denial decreased from 210(293) in FY 00 to 172(203) days in FY 01 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision decreased from 180(252) in FY 00 to 177(188) days in FY 01. This means that all of the statistics of the PMA receipt cohort for FY 01 indicate that we are making decisions faster.

The number of PMA supplements received increased from FY 00's 545 to 641in FY 01. There were 695 PMA supplement actions which is down from last year's 747 total actions. These actions included 14 panel track PMA supplement filing decisions, 87 scientific review decisions, and 594 approval decisions (see Figure 4).

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

 

Figure 4 - Shows change in PMA Supplement Approvals, Total Actions and Receipts. In FY00 it was 474 approvals, 747 Total Actions and 545 Receipts. In FY01 it was 442 Approvals, 695 Total Actions and 641 Receipts

For PMA supplements reaching final action, the average total review time increased from 94 days in FY 00 to 97 days in FY 01, and the average total elapsed time decreased from 122 days to 110 days (see Figure 5).

Figure 5. Average Review Time for PMA Supplements

Figure 5 - Shows Average Review time for PMA Supplements. In FY 00 it was 76 days of FDA time and 18 days of non-FDA time. In FY01 it was 71 days of FDA time and 26 days of non-FDA time

Unlike in FY 97, FY 98, FY 99 and FY 00, there were 6 PMA supplements active and overdue at the end of this fiscal year. The number of active supplements increased to 152 in FY 01 from 98 in FY 00, and the number of supplements on hold increased from 84 to 94. We received about 100 more PMA supplements and are reaching final decisions on more, but we are taking an average of 5 fewer days for the decisions.

For the first 6 months of FY 01 for PMA supplements receipt cohort performance, the first action and final action as follows. The average FDA days from filing to first action increased from 63 in FY 00 to 71 days in FY 01. The average FDA (total) elapsed time to an approval or denial remained the same from 65(81) in FY 00 to 65(72) in FY 01. The median FDA (total) elapsed time to an approval or denial increased from 32(40) in FY 00 to 37(43) days in FY 01.


Real-Time Review of PMA Supplements

A total of 162 requests were received and processed for real time PMA supplements in FY 01 which represents 25% of all supplements received. Of those submissions, 131 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference. The majority of these applications were reviewed in DCRD (63%) followed by DGRND (21%), DOED (5%), DRARD (5%), DCLD (4%) and DDIGD (2%). Overall, average review time from receipt to first action (approvable, not approvable or approval order) was 53 days, and was 50 days from receipt to final approval.


Product Development Protocols (PDPs)

No original PDPs nor "Real Time" PDP supplements were approved in FY 01. Seven 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 interested applicants to fully evaluate their PMA options.


Modular PMA Review

For FY01 ODE received a total of 37 PMA shells and 32 modules. A total of 7 modules were found to be acceptable while 8 received deficiency letters. A number of modules were rolled into PMA review during FY 01 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 slightly lower than 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 5 original HDEs, 6 less than the number received in FY 00. The total number of original HDE actions decreased from 36 in FY 00 to 30 in FY 01. These actions included 7 filing decisions, 15 review determinations, 4 approval decisions and 4 other final decision.

A total of 6 first actions were made this fiscal year, a decrease from 8 made last year. The average time from filing to first action decreased from 61 days in FY 00 to 42 days in FY 01.

One hundred percent of the first actions made in FY 01 occurred within 75 days.

The 4 approval decisions were comprised of 4 approved HDEs and no approvable HDEs.

In FY 01, the average elapsed time (from filing to final approval) for original HDEs was 243 days, an increase from 216 days in FY 00. The average FDA time was 143 days, an increase from 112 days in FY 00. The average non-FDA time was 100 days, a decrease from 104 days last year.

The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 7. Of these, 1 was under review and 6 were on hold. There were no active HDEs that were overdue at the end of the fiscal year.

The number of HDE supplements received increased from 10 in FY 00 to 16 in FY 01. There were 15 HDE supplement actions in FY 01, up from 11 in FY 00. These actions included 11 approval decisions and 1 not approvable decision.

A total of 12 first actions for HDE supplements were made this fiscal year, an increase from 10 last year. The average time from filing to first action increased from 44 days in FY 00 to 52 days in FY 01. Sixty-seven percent of the first actions were made within 75 days.

The average elapsed time (from filing to final approval) for HDE supplements decreased from 76 days in FY 00 to 46 days in FY 01. The average FDA time increased from 43 days in FY 00 to 46 days in FY 01. Non-FDA time decreased from 33 days in FY 00 to no days in FY 01.

The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 5. Of these, 4 were under review and 1 was on hold. There were no active HDE supplements that were overdue at the end of the fiscal year.


Investigational Device Exemptions (IDE)

During FY 01, ODE reviewed 287 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.

ODE received 284 original IDEs, a decrease from 311 received in FY 00. There were 284 decisions made on original IDEs, a decrease from 320 last year. One hundred percent of all original IDE decisions were issued within 30 days in FY 01. The average review time was 28 days.

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

Figure 6 - Shows percentage of IDEs Approved on First Review Cycle. In FY01 it was 80 percent and in FY00 it was 76 percent.
*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 76% in FY 00 to 80% in FY 01 (see Figure 6).

During this fiscal year, 206 IDE amendments were received. Decisions were made on 207 amendments: 73 approvals (35%); 39 disapprovals (19%); and 95 other administrative actions (46%). Ninety-nine percent of these decisions were made within 30 days.

It took an average total time of 141 days to approve IDEs that were initially disapproved, up from 136 days in FY 00. This average approval time consisted of 59 days for FDA time, down from 70 days last year, and 82 days for non-FDA time, up from 66 days in FY 00.

ODE received 4,811 IDE supplements during FY 01. 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 01. The average review time for IDE supplements was 21 days, up from 20 days in FY 00.


Premarket Notification (510(k)s)

ODE received 4,248 original 510(k)s, as well as 1,579 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 2,620 510(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 decreased to 96 days in FY 01 from 102 in FY 00, and the average FDA review time was 75 days, down from 77 days in FY 00. 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 and FY 01.

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

Figure 7 - shows Average 5109k) Review time for Decision Cohort. In FY00 it was 77 days FDA time and 25 days non-FDA time. In FY01 it was 75 days FDA time and 21 days non-FDA time

There were 1,316 510(k)s in inventory (those under active review or on hold) at the end of this fiscal year. The number on hold at the end of FY 01 was 382. Most important, for the sixth consecutive fiscal year there were no 510(k)s active and overdue at the end of the reporting period.

For the first 9 months of FY 01 for receipt cohort performance, the FDA time from receipt to final decision was 65 days.

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

Figure 8 - shows receipts and actions for 510(k) Receipt Cohorts - in FY00 it was 4155 for Actions and 4204 for receipts. In FY01 it was 3483 for actions and 4248 for receipts
*Cut Off Date of 9/30/01 for all receipt cohorts.
**12 month 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 remained 75 days.

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

Figure 9 - show FDA days from Recipt to Final Action for 510(k)s. The average remains at around 75 dyas in the first 9 months of FY00
*Cut Off Date as of 9/30/01 for all receipt cohorts.
**For the first 9 months of FY 01. 90th percentile data not available for FY 01.

Third-Party Review of 510(k)s

During fiscal year (FY) 2001, ODE received 107 510(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 128-percent increase over the 47 such submissions received by ODE last fiscal year. ODE made final decisions on 99 "third party" 510(k)s in FY 2001, an increase from the 46 final decisions in FY 2000. 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 65 days, as compared to the average total elapsed time of 91 days for ODE's decisions on comparable 510(k)s that did not have a third-party review.

In the FEDERAL REGISTER of March 8, 2001 (66 FR 13936), the Center announced an expansion pilot that permits third-party review of 510(k) submissions for a greatly expanded list of devices. The pilot allows—subject to certain specified conditions—third-party review of approximately 460 Class II devices for which device-specific guidance does not exist. Previously, device-specific guidance existed for each Class II device that was eligible for third-party review. The expansion more than tripled the number of eligible devices, increasing the total from 211 devices to more than 670. Information on the expansion pilot is available on the Center's third party web page.


Special 510(k)s

From October 1, 2000 to September 30, 2001 ODE received 717 Special 510(k)s out of the 4,248 total number of 510(k)s received, and 685 have received final decisions with the average FDA review time of 28 days and the average total time of 32 days, and 643 were found substantially equivalent, 3 were found not substantially equivalent, and the remaining 39 had other decisions such as withdrawn or deleted.


Abbreviated 510(k)s

During this fiscal year, ODE received 174 Abbreviated 510(k)s out of the 4,248 total number of 510(k)s received. One hundred seventy-four received final decisions (147 substantially equivalent, 1 not substantially equivalent, and 26 other decisions) with a FDA average review time of 82 days and total time of 99 days. None of the Abbreviated 510(k)s went over 90 days.


Significant Medical Device Breakthroughs

During FY 01, ODE approved 16 PMAs and cleared 10 510(k)s that represent significant medical device breakthroughs. See Part 2 - INDUSTRY INFORMATION, Significant Medical Device Breakthroughs - for a complete listing.


Classification Actions

  • Published a final rule in the Federal Register on May 16, 2001 classifying Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications into Class II.

  • Published a final rule (technical amendment) in the Federal Register on May 22, 2001 classifying Pedicle Screw Spinal Systems into Class II.


Automatic Evaluation of Class III Designation

  • Issued an order on November 13, 2000 classifying Triage B-Type Natriuretic Peptide (BNP) Test into Class II.

  • Issued an order on December 5, 2000 classifying Dulbecco's Modified Eagle Medium "DMEM" into Class II.

  • Issued an order on June 11, 2001 classifying the Given Diagnostic Imaging System into Class II.


Proposed Reclassification Actions

  • Published a proposed rule in the Federal Register on May 9, 2001 to reclassify Automated Differential Cell Counters from Class III into Class II.

  • Published a proposed rule in the Federal Register on August 15, 2001 to reclassify the Endolymphatic Shunt Tube with Valve from Class III into Class II.

  • Published a proposed rule in the Federal Register on September 6, 2001 to reclassify the Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis from Class III into Class II.


Reclassification Actions

  • Published a final rule in the Federal Register on October 10, 2000 reclassifying Endosseous Dental Implant Accessories from Class III into Class II.

  • Published a final rule in the Federal Register on February 28, 2001 reclassifying the Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis from Class III into Class II.

  • Published a final rule in the Federal Register on March 9, 2001 reclassifying the Home Uterine Activity Monitor from Class III into Class II.

  • Published a final rule in the Federal Register on April 10, 2001 reclassifying Six Cardiovascular Preamendments Class III Devices into Class II.

  • Published a notice in the Federal Register on April 30, 2001 denying the petition to reclassify the Totally Implanted Spinal Cord Stimulator.

  • Issued a reclassification order on September 4, 2001 reclassifying the Absorbable Polydioxanone Surgical Suture from Class III into Class II.


Class II Exemption Petitions

  • Published a Class II exemption in the Federal Register on October 18, 2000 for Total Triiodorthyronine Test System submitted by Abbott Laboratories.

  • Published a Class II exemption in the Federal Register on December 8, 2001 for Catheter, Retention, Barium Enema submitted by E-Z-EM, Inc.

  • Published a Class II exemption in the Federal Register on March 21, 2001 for Pharmacy Compounding System submitted by Baxter HealthCare, Corporation.

  • Published a Class II exemption in the Federal Register on September 18, 2001 for F Spoon Fluoroscopic Accessory submitted by the F Spoon Company.


Final 515(b) Calls for PMAs

There were no calls for PMAs in FY 01.