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FY 2007 and 2006 ODE Annual Report - Part 5 - Key Performance Indices

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Historically, the ODE Annual Report has included combined data for both ODE and OIVD. The FY 05 Annual Report was the first report that included only data for ODE. In this part, first, we present the major submissions1 received in ODE from FY 97 to FY 07. For these submissions (known as “the receipt cohort”), we provide our review performance for Premarket Approval Applications (PMAs), PMA supplements, Premarket Notifications (510(k)s), Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and Request for Information (513(g)s). For PMAs and 510(k)s, in addition to review performance data, we also provide our progress toward meeting MDUFMA performance goals. In the remainder of this part, we provide information on the number of major submissions processed in FY 06 and FY 07 (known as “the decision cohort”).

Major Submissions Received

As shown in Table 1, during FY 06, ODE received 9,415 major submissions, up from 8,690 in FY 05. This increase is primarily due to an increase in the total number of PMA supplements received. In FY 07, the number received went down to 9,276.

Of the 25 original PMAs and 21 panel track supplements received in FY 06, 2 were granted expedited status. Of the 31 original PMAs and 4 panel track supplements received in FY 07, 2 were granted expedited status. Similarly, 2 original and PMA panel track supplements received expedited status in FY 06. In FY 07, 18 of the 31 (58%) original PMAs were submitted as modular PMAs as compared to 11 (44%) modular PMAs submitted in FY 06.

Of the 1,113 PMA supplements received in ODE in FY 06, 212 were categorized as 180-day PMA supplements, up from 169 in FY 05. Of the 1,087 PMA supplements received in ODE in FY 07, 234 were categorized as 180-day PMA supplements, up from 212 in FY 06. The number of fee paying 180-day supplements, remains fairly stable between FY 07 (130) compared to FY 06 (128).

A total of 277 requests were received and processed for real-time PMA supplements in FY 06, up from 184 in FY 05. Of those submissions, 252 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a video conference. The majority of these applications were reviewed in DCD (78%) followed by DGRND (11%), DOED (6%), DAGID (3%), and DRARD (2%).

A total of 256 requests were received and processed for real-time PMA supplements in FY 07, slightly down from 277 in FY 06. Of those submissions, 237 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 (79%) followed by DGRND (9%), DRARD (6%), DOED (5%), and DAGID (1%).

In addition to 180-day and real-time supplements, CDRH also received 521 30-day notices/135-day supplements in FY 06, a significant increase from the number of 30-day notices/135-day supplements received in FY 05 (281). This increase is primarily due to an increase in the number of manufacturing changes associated with cardiovascular devices. CDRH received 530 30-day notices/135-day supplements in FY 07, a slight increase from the number of 30-day notices/135-day supplements received in FY 06 (521).

Of the 3,240 510(k)s received in FY 06, 2,385 were submitted as traditional 510(k)s, 130 were submitted as abbreviated 510(k)s, and the remaining 725 were Special 510(k)s.

Of the 3,192 510(k)s received in FY 07 2,402 were submitted as traditional 510(k)s, 166 were submitted as abbreviated 510(k)s and the remaining 624 were Special 510(k)s.

No 510(k)s were granted expedited status in FY 06 and one 510(k) was granted expedited status in FY 07.

ODE continues to see an increase in the number of 513(g)s received each year. A 513(g) is a request for information regarding FDA regulatory requirements applicable to a device. Two hundred and forty-four 513(g)s were received in FY 06 and 381 were received in FY 07.

ODE received approximately the same number of original IDEs and IDE supplements between FY 06 and FY 07. In FY 07, ODE received and processed 211 original IDEs and 4,345 IDE supplements as compared to 251 original IDEs and 4,485 IDE supplements in FY 04.

In FY 07, the number of original HDEs received was 6, up from 4 in FY 06. The number of HDE supplements received decreased from 53 in FY 06 to 23 in FY 07.

Table 1. Major Submissions Received
FY 97 – FY 07

TYPE OF SUBMISSION

1997

1998

1999

2000

2001

2002

 

2003

2004

2005

 

2006

2007

 

ODE&

OIVD

ODE&

OIVD

ODE&

OIVD

ODE&

OIVD

ODE&

OIVD

ODE&

OIVD

ODE&

OIVD

ODE Only

ODE Only

ODE Only

ODE Only

 

 

 

 

 

 

 

 

 

 

 

 

Original PMAs

66

48

64

67

71

49

54

37

43

25

31

PMA Supplements

409

517

557

546

641

645

666

565

712

1,113

1,087

Original IDEs

297

322

304

311

283

312

242

222

226

251

211

IDE Supplements

3,776

4,277

4,127

4,388

4,810

4,722

4,415

4,297

4,264

4,485

4,345

510(k)s

5,049

4,623

4,458

4,202

4,248

4,320

4,247

3,107

3,130

3,240

3,192

Original HDE

4

8

12

11

5

5

10

9

4

4

6

HDE Supplements

0

0

4

10

16

16

29

28

24

53

23

513(g)s

29

34

43

59

82

104

156

239

287

244

381

Total

9,630

9,829

9,569

9,594

10,156

10,192

9,819

8,504

8,690

9,415

9,276

 

ODE Review Performance

- Premarket Approval Applications (PMAs)

The figures below provide the ODE review performance for PMAs filed in FY 01 to FY 06. The data for FY 07 was not included because a significant number of PMA submissions received in FY 07 are still under review and a final decision has not been issued.

(The data for FY 07 will be presented in the next ODE annual report.)

As shown in Figure 1, the average total elapsed time for original PMAs and panel track PMA supplements has decreased overall from FY 03 to FY 06. The increase in FY 05 is likely due to a staffing shortage that occurred in 2005 due to uncertainties over the continuation of the Medical Device User Fee Program.

As shown in Figure 2, this trend for a decrease in total elapsed time has not been accompanied by a consistent decrease in FDA total time. 

Figure 1 : Average Total FDA Review Days from Filing to Approval (excluding withdrawals) for All Original and Panel Track PMA Supplements

Line graph, showing FDA days versus fiscal year. FY01, 203 days. FY02, 292 days. FY03, 229 days. FY04, 326 days. FY05, 366 days. FY06, 283 days.

Figure 2 : Average Total Elapsed Days from Filing to Approval (excluding withdrawals) for All Original and Panel Track PMA Supplements

 

Chart showing FDA days versus fiscal year. FY01, 376 days. FY02, 425 days. FY03, 289 days. FY04, 387 days. FY05, 438 days. FY06, 335 days.

Figure 3 : Average Total FDA Days from Receipt to Final Decision for all 180-day PMA Supplements –

Chart showing FDA days versus fiscal year (receipt cohort). FY01, 119 days. FY02, 113 days. FY03, 109 days. FY04, 107 days. FY05, 111 days. FY06, 109 days. FY07, 95 days.

As shown in Figure 3, the average ODE review time from receipt to final decision, one that closes a file (i.e., approvals and other final decisions such as withdrawals and conversions) for 180-day PMA supplements has continued to trend downward. For the FY 07 receipt cohort, the average ODE review time was 95 days, down from 109 days in FY 06.

Similarly, there has been significant improvement in the average total elapsed time for 180-day PMA supplements since FY 05. For the FY 07 receipt cohort, the total time was 126 days, down from 169 days in for the FY 06 receipt cohort (see Figure 4).

Figure 4 : Average Total Elapsed Days from Receipt to Final Decision for all 180-day PMA supplements.

Chart showing total days versus fiscal year (receipt cohort). FY01, 230 days. FY02, 202 days. FY03, 197 days. FY04, 181 days. FY05, 238 days. FY06, 169 days. FY07, 126 days.

Since FY 04, the average total FDA review time from receipt to final decisions (i.e., approvals and other final decisions such as withdrawals and conversions) for real-time supplements has remained fairly constant between 59 and 65 days (see Figure 5). Since the average review cycle for a real time PMA supplement is one cycle, the average FDA review time is approximately the same as the average total elapsed time. MDUFMA has resulted in a significant increase in the number of real-time supplements received by CDRH. In FY 05, 182 real-time supplements were received as compared to 256 received in FY 07, an increase of 41%.

Figure 5 : Average Total FDA Review Time for Real Time PMA Supplements
Chart. Number of days versus fiscal year (receipt cohort). FY01, 49 days. FY02, 47 days. FY03, 61 days. FY04, 65 days. FY05, 64 days. FY06, 60 days. FY07, 59 days.

- Product Development Protocols (PDPs)

No original PDPs were approved in FY 07. One routine PDP supplement and 2 Real-Time PDP Supplements, 2 special supplements and 18 30-day/135-day supplement were “approved.” Note that a PDP that has been “declared complete” is considered to have an approved PMA.

- 510(k) Review Performance

As shown in Figure 6, the average FDA review time from receipt to final decision has declined since MDUFMA. Only data through FY 06 is being presented because FY 07 is incomplete.

Figure 6: Average FDA Time From Receipt To Final Decision

Chart. FDA Days versus fiscal year (SE and NSE decisions only). 2001, 83 days. 2002, 81 days. 2003, 78 days. 2004 (cohort not complete), 64 days. 2005 (cohort not complete), 54 days. 2006 (cohort not complete), 54 days.

Figure 7 : Average Total Elapsed Time From Receipt To Final Decision

Chart showing total days versus fiscal year (SE and NSE decisions only). 2001, 105 days. 2002, 101 days. 2003, 103 days. 2004 (cohort not complete), 92 days. 2005 (cohort not complete), 87 days. 2006 (cohort not complete), 95 days.

- Third-Party Review of 510(k)s

During FY 07, ODE received 233 510(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 16 percent decrease from the 278 submissions received in 2006. ODE made final decisions on 230 “third party” 510(k)s in FY 07, a 13 percent decrease from the 264 final decisions in FY 06. As shown in Figure 8, the average total days from the time ODE received a 510(k) with a third party’s review to the time ODE issued the final decision to the 510(k) holder was 43 days in FY 07, slightly higher than in FY 06.

On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007. The act includes a provision extending authority for third party review of 510(k)s through the end of fiscal year 2012. The existing statutory authority was due to expire at the end of FY 07.

CDRH continued to take steps during FY 06 and FY 07 to improve the quality and consistency of third party reviews and facilitate ODE’s and OIVD’s timely action on these submissions. CDRH conducted telephone conferences with all third parties in March, June, and November 2006 and March 2007 to provide a routine forum for discussing issues and answering questions.

Information on the 510(k) Accredited Persons Program is available on the Center’s third party review web page at http://www.fda.gov//MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm.

Figure 8 : 510(k)s Received By ODE with a Third Party Review*

Note: Chart does not include third party submissions received by OIVD. FY2007 cohort not complete (18 pending), average days may change. Chart shows number received, fiscal year (receipt cohort), and average days to ODE decision; total time from ODE receipt to SE or NSE decision, excluding prior third party time. 2001, 96 received, 23 days. 2002, 120 received, 31 days. 2003, 185 received, 40 days. 2004, 241 received, 35 days. 2005, 240 received, 34 days. 2006, 278 received, 39 days. 2007, 233 received, 43 days.

- Humanitarian Device Exemption (HDE) Applications

ODE received 6 original HDEs in FY 07. All were still under review at the end of FY 07. Two HDEs were approved in FY 07.

- Investigational Device Exemptions (IDE) Applications

In FY 07, ODE received 211 original IDEs. There were 214 decisions made on original IDEs. Ninety-nine percent of all original IDE decisions were issued within 30 days in FY 06. The average review time was 28 days.

Figure 9: Average FDA Review Time for Original IDEs

 Chart showing FDA days versus fiscal year. FY01, 28 days. FY02, 27 days. FY03, 27 days. FY04, 28 days. FY05, 29 days. FY06, 28 days. FY07, 28 days.

In FY 07, 99% of the IDE supplements received were reviewed within the 30-day statutory timeframe. The average review time for IDE supplements has remained fairly constant.

Figure 10 : Average Total FDA Review Time for All IDE Supplements

Chart showing FDA days versus fiscal year. FY01, 21 days. FY02, 20 days. FY03, 19 days. FY04, 19 days. FY05, 19 days. FY06, 20 days. FY07, 21 days.

- Pre-IDE Submissions

During FY 07, ODE reviewed 484 pre-IDEs. Based on these reviews, guidance for the pre-original IDE submissions were provided to the sponsors through meetings, letters, fax, or by phone. The number of pre-IDE submissions has increased steadily every year due primarily to increasing awareness of the existence and usefulness of the program, as well as increasingly complex devices and combination products. The increasing number of pre-IDE submissions is likely responsible for the increase in review times seen in FY 07.

Figure 11 : Pre-IDE Submissions and Average Review Days

 Chart showing number received, number logged out, fiscal year, and average review time in days. 2001, 206 received, 216 logged out, 79 days. 2002, 280 received, 209 logged out, 83 days. 2003, 289 received, 243 logged out, 84 days. 2004, 335 received, 316 logged out, 92 days. 2005, 405 received, 388 logged out, 79 days. 2006, 406 received, 375 logged out, 80 days. 2007, 484 received, 432 logged out, 95 days.

Performance on MDUFMA Goals

FDA provides regular updates on MDUFMA performance and these reports are available at the following website: http://www.fda.gov/cdrh/mdufma. Overall, ODE has made excellent progress in implementing MDUFMA and is achieving nearly all of the performance goals. CDRH has worked hard to communicate the new requirements and challenges of MDUFMA to its staff and stakeholders. To ensure that the implementation of the new law proceeds smoothly, CDRH has worked with its stakeholders and is confident that the implementation of MDUFMA will result in significant benefits to industry, health care professionals, and, most importantly, patients.

Major Submissions Completed (Decision Cohort)

The table below summarizes the actions that ODE completed in fiscal years 1997-2007 (i.e., the “decision cohort”). Note that decisions may be made in one fiscal year for an application that was submitted in a previous fiscal year.

Table 2. Major Submissions Completed FY 97 - FY 07

TYPE OF SUBMISSION

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

 

ODE& OIVD

ODE& OIVD

ODE& OIVD

ODE& OIVD

ODE& OIVD

ODE& OIVD

ODE& OIVD

ODE

Only

ODE Only

ODE

Only

ODE Only

 

 

 

 

 

 

 

 

 

 

 

 

Original PMAs

48

40

36

42

53

41

31

29

28

27

27

PMA Supplements

401

421

440

474

442

533

494

424

354

594

578

Original IDEs

272

325

305

320

284

307

246

217

238

234

214

IDE Amendments

220

225

268

251

207

251

217

162

208

178

163

IDE Supplements

3,777

4,209

4,224

4,335

4,802

4,711

4,424

4,336

4,226

4,430

4,324

510(k)s

5,155

5,229

4,593

4,397

4,150

4,376

4,132

3,376

3,184

3,080

3,052

Original HDE

2

4

6

6

4

10

2

6

2

3

2

HDE Supplements

0

0

3

10

11

14

24

22

31

69

47

Total

9,875

10,453

9,876

9,835

9,953

10,243

9,570

8,573

8,272

8,615

8,407

 

- Premarket Approval Applications (PMAs)

In FY 07, ODE completed 103 PMA actions. These actions included 32 filing decisions, 30 major deficiency decisions, and 41 approval/approvable/not approvable decisions.

Of the 41 decisions made in FY 07 on original PMAs, 27 were approval orders, 7 were approvable and 7 were not approvable. Of the 27 approvals, 3 were for expedited PMAs. See Part 1 (ADVANCES IN PATIENT CARE) for a complete list of PMA approvals.

In FY 07, ODE completed 744 PMA supplement actions. These actions included 5 panel track PMA supplement filing decisions, 8 major deficiency decisions, 87 not approvable decisions, 66 approvable decisions and 578 approval decisions.

- Premarket Notifications (510(k)s)

ODE completed 3,080 510(k) actions in FY 06. These actions included 2,677 substantially equivalent decisions, 98 not substantially equivalent decisions, and 285 other decisions such as withdrawn or deleted.

ODE completed 3,052 510(k) actions in FY 07. these actions included 2,640 substantially equivalent decisions, 95 not substantially equivalent decisions, and 317 other decisions such as withdrawn or deleted.

During the FY 06, 703 Special 510(k)s received final decisions (689 were found substantially equivalent, 3 were found not substantially equivalent, and the remaining 11 had other decisions).

During the FY 07, 649 Special 510(k)s received final decisions (636 were found substantially equivalent, 1 was found not substantially equivalent, and the remaining 12 had other decisions).

One hundred thirty-one abbreviated 510(k)sreceived final decisions (113 substantially equivalent, 4 not substantially equivalent, and 14 other decisions) in FY 06.

One hundred thirty-four abbreviated 510(k)sreceived final decisions (113 substantially equivalent, 1 not substantially equivalent, and 20 other decisions) in FY 07.

ODE made final decisions on 264 “third party” 510(k)s in FY 06, and 230 in FY 07.

- Investigational Device Exemptions (IDEs)

Of the original IDEs which were complete enough to support substantive review, the percentage of IDEs approved on the first review cycle was 61% in FY 07. This represents a slight increase from the FY 06 performance level of 59%, although there is an increasing complexity of submissions and increasing number of combination product submissions.

Like original IDEs, the percentage of IDE supplements reviewed within the 30-day statutory timeframe was 99% in FY 07.

In FY 07, decisions were made on 163 amendments as follows: 67 approvals (41%); 32 disapprovals (19%); and 64 other administrative actions (39%).

Automatic Evaluation of Class III Designation

The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended Section 513(f) (21 U.S.C. 360c(f)) to provide a new mechanism to reclassify statutorily classified class III products.  This provision, which is referred to as the Evaluation of Automatic

Class III Designation provision (also known as "de novo" or "risk-based" classification), is intended to apply to low risk products that have been classified as class III because they were found not substantially equivalent (NSE) to any identifiable predicate device.  The process permits the Secretary (FDA, by delegation) to reclassify certain low risk devices into class I or II on the basis of established risk-based classification criteria.

FY 06

FY 07

515(b)

 Section 515(b) of the Federal Food, Drug, and Cosmetic Act (the Act) specifies that FDA will promulgate regulations requiring that the class III devices have an approval of an application for premarket approval (PMA). Class III devices are described in section 513(a)(1)(C) of the Act.

The devices covered by 515(b) requirements fall into two categories:

  • Devices in commercial distribution before May 28, 1976 (preamendment devices) that were subsequently classified by the Food and Drug Administration (FDA) as class III devices by means of classification regulations promulgated under Section 513 of the Act.
  • Devices offered for commercial distribution on or after May 28, 1976, (postamendment devices) that are determined through the 510(k) process to be substantially equivalent to class III preamendment devices.

Manufacturers of class III preamendment devices (categories 1 and 2 above) are allowed to commercially market their devices without an approved PMA until FDA publishes a final rule under 515(b) to require the filing of a PMA. In addition, these manufacturers are not required to submit a PMA until 30 months after the final promulgation of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later (See 501(f)(2)(B)). FDA may allow more than 90 days after promulgation of a final rule for submission of a PMA.

ODE did not publish any proposed or final rules under this provision in FY 06 or FY 07.

 1 A major submission is defined as an original statutory premarket application that requires FDA’s scientific review and decision.