• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

FY 2005 ODE Annual Report - Part 5 - Key Performance Indices

PDF Printer Version


Historically, the ODE Annual Report has included combined data for both ODE and OIVD. This FY 05 Annual Report is the first report that includes only data for ODE. In this part, first, we present the major submissions1 received in ODE from FY 95 to FY 05. 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 05 (known as “the decision cohort”).

Major Submissions Received

As shown in Table 1, during FY 05, ODE received 8,714 major submissions, up from 8,536 in FY 04. This increase is primarily due to an increase in the total number of PMA supplements received.

Of the 43 original PMAs and 12 panel track supplements received in FY 05, 5 were granted expedited status. In contrast, 14 original and PMA panel track supplements received expedited status in FY 04. In FY 05, 16 of the 43 (37%) original PMAs were submitted as modular PMAs as compared to 21 (57%) modular PMAs submitted in FY 04.

Of the 712 PMA supplements received in ODE in FY 05, 169 were categorized as 180-day PMA supplements, down from 235 in FY 04. The number of fee paying 180-day supplements, however, remains fairly stable between FY 05 (93) and FY 04 (97).

A total of 184 requests were received and processed for real-time PMA supplements in FY 05, slightly up from 178 in FY 04. Of those submissions, 132 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 (56%) followed by DGRND (16%), DOED (14%), DRARD (11%), and DAGID (3%).

In addition to 180-day and real-time supplements, CDRH also received 281 30-day notices/135-day supplements in FY05, a significant increase from the number of 30-day notices/135-day supplements received in FY 04 (135). This increase is primarily due to an increase in the number of manufacturing changes associated with cardiovascular devices.

Of the 3,130 510(k)s received in FY 05, 2,299 were submitted as traditional 510(k)s, 130 were submitted as abbreviated 510(k)s, and the remaining 701 were Special 510(k)s.

When compared to the 3,107 510(k)s received in FY 04, the numbers of 510(k)s received for each category remains fairly stable (2,279 traditionals, 110 abbreviated, and 718 Specials). One 510(k) was granted expedited status in FY 05.

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. Three hundred and thirteen 513(g)s were received in FY05, a 14% increase in the number of 513(g)s received in FY 04 and double the number received in FY 03.

ODE received approximately the same number of original IDEs and IDE supplements between FY 04 and FY 05. In FY 05, ODE received and processed 226 original IDEs and 4,262 IDE supplements as compared to 222 original IDEs and 4,298 IDE supplements in FY 04.

In FY 05, the number of original HDEs received was 4, down from 9 in FY 04. The number of HDE supplements received also decreased slightly from 28 in FY 04 to 24 in FY 05.

Table 1. Major Submissions Received
FY95 – FY05

TYPE OF SUBMISSION 1995 1996 1997 1998 1999 2000 2001 2002   2003 2004 2005
Original PMAs 39 44 66 48 64 67 71 49 54 37 43
PMA Supplements 499 415 409 517 557 546 641 645 666 565 712
Original IDEs 214 253 297 322 304 311 284 312 242 222 226
IDE Supplements 3,171 3,189 3,776 4,277 4,127 4,388 4,811 4,724 4,415 4,298 4,262
510(k)s 6,056 5,297 5,049 4,623 4,458 4,202 4,248 4,320 4,247 3,107 3,130
Original HDE 0 0 4 8 12 11 5 5 10 9 4
HDE Supplements 0 0 0 0 4 10 16 16 29 28 24
513(g)s   2 29 34 43 59 82 104 156 270 313
Total 9,979 9,200 9,630 9,829 9,569 9,594 10,158 10,194 9,819 8,536 8,714

ODE Review Performance

Premarket Approval Applications (PMAs)

The figures below provide the ODE review performance for PMAs filed in FY 01 to FY 04. The data for FY 05 was not included because a significant number of PMA submissions received in FY 05 are still under review and a final decision has not been issued. (The data for FY 05 will be presented in the next ODE annual report.)

As shown in Figure 1 below, the average total FDA review time for all original PMAs and panel track PMA supplements from filing to approval has improved. Likewise, the average total elapsed time from filing to approval for the “receipt cohort” has decreased from 376 days in FY 01 to 290 days in FY 04 (see Figure 2).

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

Graph. FY01, 283 FDA days. FY02, 283 FDA days. FY03, 271 FDA days. FY04, 271 FDA days.

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

Graph. FY01, 376 total days. FY02, 356 total days. FY03, 357 total days. FY04, 290 total days.

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

Graph. FY01, 118 FDA days. Fy02, 113 FDA days. FY03, 107 FDA days. FY04, 96 FDA days. FY05, 88 FDA days.

As shown in Figure 3, the average ODE review time from receipt to final decision (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 05 receipt cohort, the average ODE review time was 88 days, down from 107 days in FY 03.

Similarly, there has been significant improvement in the average total elapsed time for 180-day PMA supplements. For the FY 05 receipt cohort, the total time was 134 days, down from 156 days in for the FY 03 receipt cohort (see Figure 4).

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

Graph. FY01, 169 total days. FY02, 164 total days. FY03, 156 total days. FY04, 141 total days. FY05, 134 total days.

With the exception of FY04, 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 at approximately 50 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, ODE received 182 real-time supplements, as compared to 138 received in FY 02, an increase of 32%.

Figure 5 : Average Total FDA Review Time for Real Time PMA Supplements

Graph. FY01, 49 days. FY02, 48 days. FY03, 48 days. FY04, 61 days. FY05, 52 days.

Product Development Protocols (PDPs)

No original PDPs were approved in FY 05. One routine PDP supplement and one Real-Time PDP 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 steadily declined from FY 01 through FY 05. For FY 05, the average ODE review time was 49 days, down from 64 days in FY 04. Similarly, the average total elapsed time decreased from 92 days in FY 04 to 69 days to FY 05 (Figure 7).

Figure 6: Average FDA Time From Receipt To Final Decision

Average FDA time to 510k final decision has improved (SE & NSE decisions only). 2001, 83 FDA days. 2002, 81 FDA days. 2003, 78 FDA days. 2004 (cohort not complete), 64 FDA days. 2005 (cohort not complete), 49 FDA days.

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


Average total time to 510k final decision has improved (SE & NSE decisions only). 2001, 105 total days. 2002, 101 total days. 2003, 104 total days. 2004 (cohort not complete), 92 total days. 2005 (cohort not complete), 69 total days.

Third-Party Review of 510(k)s

During FY 05, ODE received 240 510(k)s reviewed by third-party organizations under the Accredited Persons provisions (Section 523) of the Federal Food, Drug, and Cosmetic Act.

The average days from the time FDA received the completed 510(k) from the third-party reviewer to the time FDA issued the final decision to the 510(k) holder has decreased from 35 days in FY 04 to 30 days in FY 05.

CDRH continued to take steps during FY 05 to improve the quality and consistency of third-party reviews and facilitate timely CDRH action on these submissions. CDRH conducted a training session for ODE/OIVD staff on October 22, 2004 in Rockville, Maryland, and for third-party reviewers on October 26-27, 2004 in Gaithersburg, Maryland. CDRH also conducted telephone conferences with all third-party organizations in January and April 2005 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/cdrh/thirdparty/ .

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

Graph. 510ks received by ODE with a third party review, as of december 31, 2005. In 2001, 96 received, 23 average days to decision. 2002, 120 received, 31 days. 2003, 185 received, 40 days. 2004, 241 received, 35 days. 2005 (cohort not complete), 240 received, 30 days.

Humanitarian Device Exemption (HDE) Applications

ODE received 4 original HDEs in FY 05. Three were still under review at the end of FY05 and one was approved. The total FDA review time for the HDE approval was 181 days.

Investigational Device Exemptions (IDE) Applications

In FY 05, ODE received 226 original IDEs. There were 238 decisions made on original IDEs. One hundred percent of all original IDE decisions were issued within 30 days in FY 05. The average review time was 29 days.

Figure 9: Average FDA Review Time For Original IDEs  

Average IDE review time for original IDEs has remained constant.

In FY 05, 100% of the IDE supplements received were reviewed within the 30-day statutory timeframe. The average review time for IDE supplements slightly increased from 18 to 20 days.

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


Average FDA review time for all IDE supplements has remained constant.

Pre-IDE Submissions

During FY 05, ODE received 405 pre-IDEs. Based on these reviews, guidance for the pre-original IDE submissions were provided to the sponsors through meetings with the sponsors, 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. Review times for pre-IDEs have stayed about the same over the period of FY 01 through FY 05 despite significantly increased demands on the program.  

Figure 11 : Pre-IDE Submissions and Average Review Days

Graph. Pre-IDE submissions received/logged out by ODE. In 2001, 206 received, 216 logged out, 79 average review time. In 2002, 280 received, 209 logged out, 83 average review time. In 2003, 289 received, 243 logged out, 84 average review time. In 2004, 335 received, 316 logged out, 92 average review time. In 2005, 405 received, 388 logged out, 79 average review time.

Performance on MDUFMA Goals

FDA provides regular updates on MDUFMA performance and these reports are available at the following website: 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 1995-2005 (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 95 - FY 05

TYPE OF SUBMISSION 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Original PMAs 27 43 48 40 36 42 53 41 31 30 29
PMA Supplements 435 462 401 421 440 474 442 533 494 424 354
Original IDEs 210 260 272 325 305 320 284 307 246 217 238
IDE Amendments 213 218 220 225 268 251 207 251 217 162 208
IDE Supplements 3,181 3,121 3,777 4,209 4,224 4,335 4,803 4,711 4,424 4,336 4,226
510(k)s 7,948 5,563 5,155 5,229 4,593 4,397 4,150 4,376 4,132 3,376 3,184
Original HDE 0 0 2 4 6 6 4 6 2 6 2
HDE Supplements 0 0 0 0 3 10 11 13 24 22 31
Total 12,014 9,667 9,875 10,453 9,876 9,835 9,954 10,238 9,570 8,573 8,272

Premarket Approval Applications (PMAs)

In FY 05, ODE completed 121 PMA actions. These actions included 43 filing decisions, 29 major deficiency decisions, and 49 approval/approvable/not approvable decisions.

Of the 49 decisions made in FY 05 on original PMAs, 29 were approval orders, 14 were approvable and 6 were not approvable. Of the 29 approvals, 4 were for expedited PMAs. See Part 1 (ADVANCES IN PATIENT CARE) for a complete list of PMA approvals.

In FY 05, ODE completed 527 PMA supplement actions. These actions included 14 panel track PMA supplement filing decisions, 4 major deficiency decisions, 73 not approvable decisions, 82 approvable decisions and 354 approval decisions in FY 05.

Premarket Notifications (510(k)s)

ODE completed 3,185 510(k) actions in FY 05. These actions included 2,784 substantially equivalent decisions, 108 not substantially equivalent decisions, and 293 other decisions such as withdrawn or deleted.

During the fiscal year, 684 Special 510(k)s received final decisions (662 were found substantially equivalent, 2 were found not substantially equivalent, and the remaining 20 had other decisions).

One hundred thirty-two abbreviated 510(k)sreceived final decisions (118 substantially equivalent, 3 not substantially equivalent, and 11 other decisions).

ODE made final decisions on 248 “third party” 510(k)s in FY 05, a 7% increase from the 231 final decisions in FY 04.

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 59% in FY 05. This represents a decrease from the FY04 performance level of 74%, primarily attributed to the increasing complexity of submissions, and the increasing number of combination product submissions.

Like original IDEs, the percentage of IDE supplements reviewed within the 30-day statutory timeframe was 100% in FY 05.

In FY 05, decisions, as follows, were made on 208 amendments: 75 approvals (36%); 53 disapprovals (26%); and 80 other administrative actions (38%).

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.

  • Issued an order on August 4, 2005 classifying Endosensor with Delivery System and Endosensor Electronics System into class II 870.2855.
  • Issued an order on January 14, 2005 classifying Decapinol Oral Rinse into class II 872.5580.
  • Issued an order on November 4, 2004 classifying Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®) into class II 884.6200


 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 specified below 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 rules under this provision in FY 05,. ODE did publish one final rule:

  • Published a final rule in the Federal Register on October 4, 2004 requiring Premarket Approval for Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained Resurfacing Cemented Prosthesis.

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