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FY 2002 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
Device Guidance Documents
Significant Medical Device Approvals
Reclassification Petitions
Proposed Classification Actions
Proposed Reclassification Actions
Final Reclassification Actions
Automatic Evaluation of Class III Designation
Federal Register Notice
Final 515(b) Call 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 2002 (FY 02). Most of the data discussed below can be found in the tables below and in Part 7- 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 2002 with 354 employees. During the year, ODE lost 23 full-time employees (13 scientific reviewers, 8 medical officers and 2 clericals) through resignation, reassignment or retirement, and added 27 new employees (10 scientific reviewers, 2 medical officers, 5 clericals and 10 non-paid student interns and contractors).

 Workload

During FY 02, ODE received 10,321 major submissions compared to 10,282 major submissions in FY 01. [See Table 1 for a breakdown of major submissions received.]

 Table 1. Major Submissions Received
FY 92 – FY 02

TYPE OF SUBMISSION

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

                       

Original PMAs

65

40

43

39

44

66

48

64

67

71

48

PMA Supplements

606

395

372

499

415

409

517

557

546

641

644

Original IDEs

229

241

171

214

253

297

322

304

311

284

312

IDE Amendments

297

320

254

210

219

223

226

275

240

206

252

IDE Supplements

3,644

3,668

3,020

3,171

3,189

3,776

4,277

4,127

4,388

4,811

4,724

510(k)s

6,509

6,288

6,434

6,056

5,297

5,049

4,623

4,458

4,202

4,248

4,320

Original HDE

0

0

0

0

0

4

8

12

11

5

5

HDE Supplements

0

0

0

0

0

0

0

4

10

16

16

Total

11,350

10,952

10,294

10,189

9,417

9,824

10,021

9,801

9,775

10,282

10,321

On the decision side, ODE completed the processing of 10,237 major submissions, compared to 9,954 major submissions in FY 01. [See Table 2 for major submissions completed.]

 

 Table 2. Major Submissions Completed
FY 92 - FY 02

TYPE OF SUBMISSION

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

                       

Original PMAs

12

24

26

27

43

48

40

37

42

53

41

PMA Supplements

394

354

385

435

462

401

421

440

474

442

532

Original IDEs

215

248

174

210

260

272

325

305

320

284

307

IDE Amendments

297

324

256

213

218

220

225

268

251

207

251

IDE Supplements

3,469

3,814

3,070

3,181

3,121

3,777

4,209

4,224

4,335

4,803

4,711

510(k)s

4,862

5,073

7,135

7,948

5,563

5,155

5,229

4,593

4,397

4,150

4,376

Original HDE

0

0

0

0

0

2

4

6

6

4

6

HDE Supplements

0

0

0

0

0

0

0

3

10

11

13

Total

9,249

9,837

11,046

12,014

9,667

9,875

10,453

9,876

9,835

9,954

10,237

 Premarket Approval Applications (PMAs)

ODE received 48 original PMAs (23 less than the number received in FY 01). The total number of PMAs in inventory (active and on hold) at the end of this fiscal year decreased from 85 in FY 01 to 65. The number of active PMAs under review decreased at the end of FY 02 to 34 compared to 46 last year, and those on hold decreased from 39 in FY 01 to 31 in FY 02.

The total number of PMA actions decreased from 282 to 236 actions. These actions included 46 filing decisions, 122 review determinations, and 68 approval/approvable/not approvable decisions.

The 68 original PMA decisions were comprised of 41 approved PMAs, 17 approvable PMAs, and 10 not approvable PMAs. Of the 41 approvals, 10 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 129 days in FY 01 to 160 days in FY 02. The non-FDA component of review time increased from 43 days in FY 01 to 53 days this fiscal year. Thus, the total average review time increased to 213 days from 172 days.


Figure 1. Average Review Time for PMA Decision Cohort Approvals
Bar Chart. In days: FY98 - FDA 158, Non-FDA 41,; FY99 - FDA 154 - non - 26; FY00 - FDA 173, non-41; FY01 - FDA-129, non-43; FY02 - FDA 160, non 53

 

Of greater significance to industry is the total elapsed time from submission to decision.
In FY 02, the total average elapsed time for PMA decision cohort performance decreased from 411 days in FY 01 to 364 days in FY 02.

 Figure 2. Original Receipt Cohort PMAs Received and Filed

 Bar Chart. For each FY, the numbers (in days) presented are for Received, Filed, then Not Filed; FY98 = 48/38/3; FY99 = 64/55/1; FY00 = 67/68/3; FY01 = 71/67/3; FY02* = 48/16/0

*First six months

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


Bar Chart. For each Fiscal Year, then numbers (in days) are for FDA Time/Non-FDA Time; FY98 = 235/127; FY99 = 277/117; FY00 = 222/104; FY01 = 218/47; FY02* = 203/6
*First six months

For the first 6 months of FY 02 for PMA receipt cohort performance, the average FDA days from filing to first action decreased from 132 in FY 01 to 126 days.

The average FDA (total) elapsed time to an approval or to a denial decreased from 218(265) in FY 01 to 203(209) days in FY 02 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision decreased from 182(234) in FY 01 to 178(180) days in FY 02. This means that all of the statistics of the PMA receipt cohort for FY 02 indicate that we are making decisions faster.

The number of PMA supplements received increased from FY 01’s 641 to 644 in FY 02. There were 814 PMA supplement actions which is up from last year’s 696 total actions. These actions included 24 panel track PMA supplement filing decisions, 105 scientific review decisions, and 685 approval decisions (see Figure 4).

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

Bar Chart. For each Fiscal Year, the numbers represent the number of supplements that had Approvals/Total Actions/Receipts; FY98 = 421/670/517; FY99 = 440/704/557; FY00 = 474/748/546; FY01 = 442/696/641; FY02 = 532/814/644

For PMA supplements reaching final action, the average total review time increased from 97 days in FY 01 to 105 days in FY 02 (see Figure 5), and the average total elapsed time increased from 110 days to 124 days.

 Figure 5. Average Review Time for PMA Supplements

Bar Chart. For each fiscal year, the number (in days) represents FDA time/non-fda time; FY98 - 82/25; FY99 = 76/18; FY00 = 76/18; FY01 = 71/26; FY02 = 85/20

Unlike in FY 98, FY 99, FY 00 and FY 01, there were no PMA supplements active and overdue at the end of this fiscal year. The number of active supplements decreased to 126 in FY 02 from 154 in FY 01, and the number of supplements on hold increased from 95 to 98. We received 3 more PMA supplements and are reaching final decisions on more, but we are taking an average of 14 more days for the decisions.

For the first 6 months of FY 02 for PMA supplements receipt cohort performance, the first action and final action are as follows. The average FDA days from filing to first action increased from 71 in FY 01 to 72 days in FY 02. The average FDA (total) elapsed time to an approval or denial decreased from 76(93) in FY 01 to 70(78) in FY 02. The median FDA (total) elapsed time to an approval or denial increased from 33(42) in FY 01 to 35(38) days in FY 02.

 Real-Time Review of PMA Supplements

A total of 139 requests were received and processed for real time PMA supplements in FY 02 which represents 22% of all supplements received. Of those submissions, 117 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference. The majority of these applications were reviewed in DCD (41%) followed by DGRND (24%), DOED (17%), DRARD (7%), DCLD (6%) and DAGID (5%). Overall, average review time from receipt to final approval was 38 days.

 Product Development Protocols (PDPs)

No original PDPs were approved in FY 02. One routine PDP supplement and two “Real Time” 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 FY 02 ODE received a total of 30 PMA shells and 79 modules. A total of 11 modules were found to be acceptable while 11 received deficiency letters. A number of modules were rolled into PMA review during FY 02 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. 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, the same number received in FY 01. The total number of original HDE actions decreased from 30 in FY 01 to 23 in FY 02. These actions included 7 filing decisions, 8 review determinations, 6 approval decisions and 2 other final decisions.

A total of 6 first actions were made this fiscal year, equal to 6 made last year. The average time from filing to first action increased from 42 days in FY 01 to 53 days in FY 02.

Eighty-three percent of the first actions made in FY 02 occurred within 75 days.

The 6 approval decisions were comprised of 6 approved HDEs and no approvable HDEs.

In FY 02, the average elapsed time (from filing to final approval) for original HDEs was 302 days, an increase from 243 days in FY 01. The average FDA time was 175 days, an increase from 143 days in FY 01. The average non-FDA time was 127 days, an increase from 100 days last year.

The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 4. Of these, 1 was under review and 3 were on hold. There were no active HDEs that were overdue at the end of the fiscal year.

The number of HDE supplements received stayed the same at 16 in FY 01 and 16 in FY 02. There were 27 HDE supplement actions in FY 02, up from 13 in FY 01. These actions included 13 approval, 6 approvable decisions and 6 not approvable decision.

A total of 17 first actions for HDE supplements were made this fiscal year, an increase from 12 last year. The average time from filing to first action increased from 52 days in FY 01 to 53 days in FY 02. Ninety-four percent of the first actions were made within 75 days.

The average elapsed time (from filing to final approval) for HDE supplements increased from 46 days in FY 01 to 74 days in FY 02. The average FDA time increased from 46 days in FY 01 to 60 days in FY 02. Non-FDA time increased from no days in FY 01 to 14 days in FY 02.

The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 8. Of these, 4 were under review and 4 were on hold. There were no active HDE supplements that were overdue at the end of the fiscal year.

 Investigational Device Exemptions (IDE)

During FY 02, ODE reviewed 297 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 312 original IDEs, an increase from 284 received in FY 01. There were 307 decisions made on original IDEs, an increase from 284 last year. Ninety-nine percent of all original IDE decisions were issued within 30 days in FY 02. The average review time was 28 days.

 Figure 6. Percentage of IDEs Approved on First Review Cycle*
Bar Chart. Percentage for each fiscal year is as follows: FY02 = 74; FY01 = 80; FY00 = 76; FY99 = 68; FY98 = 71

 

*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 decreased from 80% in FY 01 to 74% in FY 02 (see Figure 6).

During this fiscal year, 252 IDE amendments were received. Decisions were made on 251 amendments: 86 approvals (34%); 55 disapprovals (22%); and 110 other administrative actions (44%). One hundred percent of these decisions were made within 30 days.

It took an average total time of 135 days to approve IDEs that were initially disapproved, down from 141 days in FY 01. This average approval time consisted of 68 days for FDA time, up from 59 days last year, and 67 days for non-FDA time, down from 82 days in FY 01.

ODE received 4,724 IDE supplements during FY 02. 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% in FY 02. The average review time for IDE supplements was 20 days, down from 21 days in FY 01.

 Premarket Notification (510(k)s)

ODE received 4,320 original 510(k)s, as well as 1,780 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 2,385 510(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 increased to 100 days in FY 02 from 96 in FY 01, and the average FDA review time was 79 days, up from 75 days in FY 01. 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 74 days in FY 02.

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

Bar Chart. For each fiscal year, the numbers in days are for FDA time/Non-FDA time; FY98 = 89/25; FY99 = 80/22; FY00 = 77/25; FY01 = 75/21; FY02 = 79/21

There were 1,272 510(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 02 was 337. Most important, for the seventh 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 02 for receipt cohort performance, the FDA time from receipt to final decision was 64 days.

 Figure 8. Receipts and Actions for 510(k) Receipt Cohorts*
Bar Chart. For each fiscal year, the numbers represent Actions/Receipts; FY02** = 2725/3165; FY01 - 4205/4254; FY00 = 4204/4204; FY99 = 4466/4466; FY 98 = 4629/4629

 

*Cut Off Date of 9/30/02 for all receipt cohorts.
**12 month projection based on first 9 months of receipts

For the first 9 months of FY 02 for receipt cohort performance, the total time from receipt to final decision increased to 76 days.

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


Bar graph representing FY 90th, 50th and average vs number of days. Beginning in FY92 at approximately 350/110/110 and ending at FY02 with an average of approximately 90 and 50th of 90. Note footnotes below for FY02**

*Cut Off Date as of 9/30/02 for all receipt cohorts.
**For the first 9 months of FY 02. 90th percentile data not available for FY 02.
[Accessibility]

 Third-Party Review of 510(k)s

During fiscal year (FY) 2002, ODE received 127 510(k)s reviewed by third-party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. This was a 19 percent increase over the 107 submissions received by ODE last fiscal year. The increase can be attributed to the expansion pilot implemented in March 2001 that permits third-party review of 510(k) submissions for a greatly expanded list of eligible 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. Submissions for expansion pilot devices increased from 8 in FY 2001 to 29 this year, while submissions for non-pilot devices remained virtually unchanged (99 in FY 2001 versus 98 this year).

ODE made final decisions on 132 “third party” 510(k)s in FY 2002, an increase from the 99 final decisions in FY 2001. 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 70 days for non-pilot devices and 105 days for expansion pilot devices, as compared to the average total elapsed time of 105 days (non-pilot devices) and 147 days (expansion pilot devices) for ODE’s decisions on comparable 510(k)s that did not have a third-party review. Thus, 510(k)s with a third-party review received marketing clearance 33 percent faster (non-pilot devices) and 29 percent faster (expansion pilot devices) than comparable 510(k)s reviewed entirely by ODE.

Information on the 510(k) Accredited Persons Program and the expansion pilot is available on the Center’s third party web page.

 Special 510(k)s

From October 1, 2001 to September 30, 2002 ODE received 787 Special 510(k)s out of the 4,320 total number of 510(k)s received, and 776 have received final decisions with the average FDA review time of 28 days and the average total time of 33 days, and 735 were found substantially equivalent, 2 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 185 Abbreviated 510(k)s out of the 4,320 total number of 510(k)s received. One hundred sixty-five received final decisions (131 substantially equivalent, 2 not substantially equivalent, and 32 other decisions) with a FDA average review time of 91 days and total time of 119 days. None of the Abbreviated 510(k)s went over 90 days.

 Device Guidance Documents

By the end of this fiscal year, ODE issued 15 final guidance documents and drafted for comment another 9 guidances. These documents are listed under Part 2 – Industry Information.

Guidance documents have become increasingly important in the review of PMAs and 510(k)s. In order to show the effect of guidance on 510(k) review times, we compared all SE decisions (1,644) for FY 2002 made on traditional and abbreviated 510(k)s for Class II devices eligible for third party review (excluding 510(k)s reviewed by 3rd parties). This analysis can only be conducted for class II devices eligible for third party review because the Center's classification database indicates whether guidance exists for these devices and not for others. These 1,644 decisions accounted for 58% of all SE decisions (2,808) made during FY 2002 for traditional and abbreviated 510(k)s that were not reviewed by 3rd parties. (The remaining 42% of traditional and abbreviated 510(k)s were for Class I devices, Class III devices, or Class II devices that are ineligible for 3rd party review because they are permanently implantable, life sustaining/supporting, or require clinical data.)

Specifically, the 1,644 510(k)s consist of 949 traditional 510(k)s and 72 abbreviated 510(k)s for devices with guidance and 603 traditional 510(k)s and 20 abbreviated 510(k)s for devices without guidance. Our analysis indicates that for these reviews, devices with guidance received marketing clearance 24% faster, on average, than devices without guidance (106 days versus 140 days).

The following chart illustrates the impact made by guidance documents on review times for 510(k)s.

 Significant Medical Device Approvals

During FY 02, ODE approved 17 PMAs and cleared 13 510(k)s that represent significant medical device breakthroughs. See Part 2 - INDUSTRY INFORMATION, Significant Medical Device Approvals - for a complete listing.

 Reclassification Petitions

Any interested person may submit a petition to the agency for reclassification of a device, e.g., from class III to class II, or class II to class I. Additionally, the agency on its own initiative, may follow procedures to reclassify a generic type of device. There are five sections under the Federal Food, Drug, and Cosmetic Act by which we may reclassify a device, section 513(e), 513(f) 514(b), 515(b) and 520(l) depending on the status of the device type, such as new device types found to be not substantially equivalent or transitional devices formerly regulated as drugs. The reclassification petition needs to contain sufficient information to allow FDA to determine that the proposed classification can provide reasonable assurance of safety and effectiveness. Reclassification petitions and their final decisions are put on public display at the Dockets Management Branch.

 Proposed Classification Actions

  • Published a proposed rule in the Federal Register on February 7, 2002 to classify Resorbable Calcium Salt Bone Void Filler Device into class II.
  • Published a proposed rule in the Federal Register on February 7, 2002 to classify Medical Washer and Medical Washer-Disinfector into class II.
  • Published a proposed rule in the Federal Register on April 5, 2002 to classify Intraoral Devices for Snoring and/or Obstructive Sleep Apnea into class II.
  • Published a proposed rule in the Federal Register on August 14, 2002 to classify Dental Sonography Device and the Jaw Tracking Device into class I and II (depending upon the indication).

 Proposed Reclassification Actions

  • Published a proposed rule in the Federal Register on February 12, 2002 to reclassify Cutaneous Carbon Dioxide (PcCO2) and the Cutaneous Oxygen (Pc)2) Monitor from class II (performance standards) to class II (special controls).
  • Published a proposed rule in the Federal Register on February 21, 2002 to reclassify Cyclosporine and Tacrolimus Assays from class III to class II.
  • Published a proposed rule in the Federal Register on May 14, 2002 to reclassify Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments from class III to class II.

 Final Reclassification Actions

  • Published a final rule in the Federal Register on November 15, 2001 to reclassify Three Anesthesiology Preamendments class III devices into class II. [Effective 12-17-01].
  • Published a final rule in the Federal Register on January 14, 2002 to reclassify the Automated Differential Cell Counter from class III to class II. [Effective 2-13-02].
  • Published a final rule in the Federal Register on April 29, 2002 to reclassify the Endolymphatic Shunt Tube with Valve from class III to class II. [Effective 5-29-02].
  • Published a final rule in the Federal Register on April 30, 2002 to reclassify the Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis from class III to class II. [Effective 5-30-02]
  • Published a final rule in the Federal Register on July 17, 2002 to reclassify Polymethylemthacrylate (PMMA) Bone Cement from class III to class II. [Effective 8-16-02]
  • Published a final rule in the Federal Register on September 16, 2002 to reclassify Cyclosporine and Tacrolimus Assays from class III to class II. [Effective 10-16-02]

 Automatic Evaluation of Class III Designation

  • Issued an order on May 24, 2002 classifying the Air-Conduction Hearing Aid with a functional piercing (implanted portion) into class II.

 Federal Register Notice

  • Published a Federal Register Notice on September 6, 2002 Denying the Request for Change in Classification of Hip Joint Metal/Metal Semi-Constrained, With a Cemented Acetabular Component, Prosthesis and Hip Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis from class III to class II.

 Final 515(b) Call for PMAs

  • Issued a final rule in the Federal Register on June 14, 2002 to require the filing of a Premarket Approval Application or Product Development Protocol for Glans Sheath Devices.