FY 2005 OIVD Annual Report - Part 3 – Key Performance Indices

Historically, the ODE Annual Report has included premarket combined data for both ODE and OIVD. For FY 05, OIVD and ODE have generated separate annual reports. This is the first report that includes only data for OIVD. For additional information on the premarket review program please refer to the ODE annual report. In this part, first, we present the major submissions¹ received in OIVD for FY 04 and 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), Pre-IDEs, Humanitarian Device Exemptions (HDEs), and Request for Classification 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 second part of this section, 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, OIVD received 666 major submissions, a slight increase from 659 submissions received in FY 04.

Of the 6 original PMAs and 1 panel track supplement received in FY 05, only 1 was granted expedited status. Similarly, in FY 04, only 2 out of 14 original PMAs and panel track supplements submitted to OIVD received expedited status. In FY 05, none of the 6 original PMAs were submitted as modular PMAs as compared to 3 out of 14 (21%) PMAs submitted as modular PMAs in FY 04.

Of the 84 PMA supplements received in OIVD in FY 05, 18 were categorized as 180-day PMA supplements, up from 10 in FY 04. The number of fee paying 180-day supplements, however, remains stable between FY 05 (8) and FY 04 (8).

A total of 11 requests were received and processed as Real-time PMA supplements in FY 05, slightly down from 17 in FY 04. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference.

OIVD received 17 Special PMA supplements in FY 05, an increase from 7 in FY 04.

In addition to 180-day, Special and Real-time supplements, OIVD also received 37 30-day notices/135-day supplements in FY05, a slight increase from the 34 30-day notices/135-day supplements received in FY 04.

Of the 520 510(k)s received in FY 05, 455 were submitted as traditional 510(k)s, 16 were submitted as abbreviated 510(k)s, and the remaining 49 were Special 510(k)s. One 510(k) was granted expedited status in FY 05.

Since FY 03, OIVD has seen a significant increase in the number of 513(g)s received every year. A 513(g) is a request for information regarding FDA regulatory requirements applicable to a device. Thirty-one and twenty-six 513(g)s were received in FY 04 and FY 05, respectively. This almost doubled the number of 513(g)s received in the two previous years.

OIVD received a slight increase in the number of original IDEs and IDE supplements between FY 04 and FY 05. In FY 05, OIVD received and processed 6 original IDEs and 23 IDE supplements as compared to 4 original IDEs and 14 IDE supplements in FY 04.

In FY 05, OIVD received 1 original HDE and no HDE supplements as compared to 1 original HDE and 1 HDE supplement in FY04.

Table 1. Major Submissions Received FY 04 – FY 05

TYPE OF SUBMISSION	2004 OIVD	2005 OIVD
Original PMAs	14	6
PMA Supplements	69	84
Original IDEs	4	6
IDE Supplements*	14	23
510(k)s	525	520
Original HDE	1	1
HDE Supplements	1	0
513(g)s	31	26
Total	659	666

* Pre-IDEs reported separately

OIVD Review Performance

Premarket Approval Applications (PMAs)

Figures 1 and 2 below provide the OIVD 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. Therefore, the data for FY 05 will be presented in the next OIVD annual report. Additional PMA related performance is presented in Figures 3-5.

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

Average Total FDA Review Time For All Original and Panel-Track Supplements

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

Average Total Elapsed Time For All Original PMAs and PT Supplements

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

Average Total FDA Review Time to Final Decision for all 180-Day PMA Supplements

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

Average Total Elapsed Time to Final Decisions for all 180-Day PMA Supplements

Product Development Protocols (PDPs)

No original PDPs or PDP supplements were approved in FY 05. 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 slightly from FY 01 through FY 05. For FY 05, the average OIVD review time was 61 days, up from 59 days in FY 04. Similarly, the average total elapsed time increased from 84 days in FY 04 to 88 days in FY 05 (Figure 7).

Figure 6: Average Total FDA Time from Receipt to Final Decision

OIVD 510(k)s: Average FDA Time to Final Decision - As of December 31, 2005

Figure 7: Average Total Elapsed Time from Receipt to Final Decision

OIVD 510(k)s: Average Total Time to Final Decision - As of December 31, 2005

Third-Party Review of 510(k)s

During FY 05, OIVD received three 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 was 40 days in FY 05, unchanged from FY 04 (Figure 8).

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 OIVD with a Third-Party Review

510(k)s Received by OIVD With a Third-Party Review - As of 31-Dec-2005

Humanitarian Device Exemption (HDE) Applications

OIVD received 1 original HDE in FY 05 and it is still under review.

Investigational Device Exemptions (IDE) Applications

In FY 05, OIVD received 6 original IDEs and 6 decisions were made. One hundred percent of all original IDE decisions were issued within 30 days in FY 05. The average review time was 16 days (Figure 9).

Figure 9: Average FDA Review Time for Original IDEs

Average FDA Review Time for All Original IDEs

In FY 05, 100% of the IDE supplements received were reviewed within the 30-day statutory timeframe. As shown in Figure 10, the average review time for IDE supplements has remained fairly constant.

Figure 10: Average FDA Review Time for All IDE Supplements

Average FDA Review Time for All IDE Supplements

 

Pre-IDE Submissions

During FY 05, OIVD reviewed 141 pre-IDEs. Based on these reviews, guidance for the pre-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 actually decreased over the period of FY 01 through FY 05 despite significantly increased demands on the program (Figure 11).

Figure 11: Pre-IDE Submissions and Average Review Days

Pre-IDE Submissions Received / Logged Out by OIVD

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, OIVD 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 OIVD completed in fiscal years 2004-2005 (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 04 - FY 05

TYPE OF SUBMISSION	2004 OIVD	2005 OIVD
Original PMAs	13	11
PMA Supplements	41	28
Original IDEs	4	6
IDE Amendments	0	0
IDE Supplements	12	23
510(k)s	541	504
Original HDE	1	0
HDE Supplements	1	0
Total	613	572

Premarket Approval Applications (PMAs)

In FY 05, OIVD completed 20 PMA actions on 11 original PMA submissions. These actions included 5 filing decisions, 4 major deficiency decisions, and 11 approval/approvable/not approvable decisions.

Of the 11 approval/approvable/not approvable decisions made in FY 05 on original PMAs, 9 were approval orders, 1 was approvable and 2 were not approvable. Of the 9 approvals, none were for expedited PMAs. See Part 1 (ADVANCES IN PATIENT CARE) for a complete list of PMA approvals.

In FY 05, OIVD completed 49 PMA supplement actions on 28 PMA supplement submissions. These actions included 2 panel-track PMA supplement filing decisions, 6 not approvable decisions, 2 major deficiency decisions, 11 approvable decisions and 28 approval decisions in FY 05.

Premarket Notifications (510(k)s)

OIVD completed 504 510(k) actions in FY 05. These actions included 434 substantially equivalent decisions, 16 not substantially equivalent decisions, and 54 other decisions such as withdrawn or deleted.

During the fiscal year, 53 Special 510(k)s received final decisions (49 were found substantially equivalent, 0 were found not substantially equivalent, and the remaining 4 had other decisions).

Sixteen abbreviated 510(k)s received final decisions (15 substantially equivalent, 0 not substantially equivalent, and 1 other decision).

OIVD made final decisions on 3 “third party” 510(k)s in FY 05, 3 substantially equivalent.

Investigational Device Exemptions (IDEs)

The percentage of IDEs approved on the first review cycle was 100% in FY 05. Like original IDEs, the percentage of IDE supplements reviewed within the 30-day statutory timeframe was 100% in FY 05.

Automatic Evaluation of Class III Designation (De Novo)

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. See Part 1 (ADVANCES IN PATIENT CARE) for a complete list of Automatic Evaluation of Class III Designated products.

 

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