FY 2003 ODE/OIVD 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 Supplement Decision Cohort Final Actions

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
ODE/OIVD Device Guidance Documents
Significant Medical Device Approvals
Reclassification Petitions
Proposed Classification Actions
Final Classification Actions
Proposed Reclassification Actions
Final Reclassification Actions
Automatic Evaluation of Class III Designation
513(g) Submissions

ODE/OIVD are 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 and OIVD’s review activities and performance for Fiscal Year 2003 (FY 03). Most of the data discussed below can be found in the tables below and in Part 7- OPERATIONAL STATISTICS. 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 2003 with 338 employees. During the year, ODE lost 17 full-time employees (13 scientific reviewers, 2 medical officers, 1 clerical and 1 program analyst) through resignation, reassignment or retirement and added 72 new employees (34 scientific reviewers, 9 medical officers, 5 project managers, 1 clerical, 7 paid student interns, 12 non-paid student interns and/or contractors, and 4 joint hires with OSB (2), OST and OHIP).

OIVD ended FY 2003 with 71 employees. During the year, OIVD lost 4 full-time employees (4 scientific reviewers) through resignation, reassignment or retirement and added 17 new employees (10 scientific reviewers, 2 project managers, 1 consumer safety technician, 1 medical officer, and 3 managers (one of which is a medical officer).

 Workload

During FY 03, ODE/OIVD received 9,872 major submissions compared to 10,323 major submissions in FY 02. [See Table 1 for a breakdown of major submissions received.]

 

 Table 1. Major Submissions Received
FY 93 – FY 03

TYPE OF SUBMISSION	1993	1994	1995	1996	1997	1998	1999	2000	2001	2002	2003
Original PMAs	40	43	39	44	66	48	64	67	71	49	54
PMA Supplements	395	372	499	415	409	517	557	546	641	645	669
Original IDEs	241	171	214	253	297	322	304	311	284	312	242
IDE Amendments	320	254	210	219	223	226	275	240	206	252	216
IDE Supplements	3,668	3,020	3,171	3,189	3,776	4,277	4,127	4,388	4,811	4,724	4,415
510(k)s	6,288	6,434	6,056	5,297	5,049	4,623	4,458	4,202	4,248	4,320	4,247
Original HDE	0	0	0	0	4	8	12	11	5	5	10
HDE Supplements	0	0	0	0	0	0	4	10	16	16	29
Total	10,952	10,294	10,189	9,417	9,824	10,021	9,801	9,775	10,282	10,323	9,872

On the decision side, ODE/OIVD completed the processing of 9,570 major submissions, compared to 10,238 major submissions in FY 02. [See Table 2 for major submissions completed.]

 Table 2. Major Submissions Completed
FY 93 - FY 03

TYPE OF SUBMISSION	1993	1994	1995	1996	1997	1998	1999	2000	2001	2002	2003
Original PMAs	24	26	27	43	48	40	36	42	53	41	31
PMA Supplements	354	385	435	462	401	421	440	474	442	533	494
Original IDEs	248	174	210	260	272	325	305	320	284	307	246
IDE Amendments	324	256	213	218	220	225	268	251	207	251	217
IDE Supplements	3,814	3,070	3,181	3,121	3,777	4,209	4,224	4,335	4,803	4,711	4,424
510(k)s	5,073	7,135	7,948	5,563	5,155	5,229	4,593	4,397	4,150	4,376	4,132
Original HDE	0	0	0	0	2	4	6	6	4	6	2
HDE Supplements	0	0	0	0	0	0	3	10	11	13	24
Total	9,837	11,046	12,014	9,667	9,875	10,453	9,876	9,835	9,954	10,238	9,570

 Premarket Approval Applications (PMAs)

ODE/OIVD received 54 original PMAs (5 more than the number received in FY 02). The total number of PMAs in inventory (active and on hold) at the end of this fiscal year increased from 73 in FY 02 to 83. The number of active PMAs under review decreased at the end of FY 03 to 35 compared to 42 last year, and those on hold increased from 31 in FY 02 to 48 in FY 03.

The total number of PMA actions decreased from 237 to 198 actions. These actions included 54 filing decisions, 87 scientific review decisions, and 57 approval/approvable/not approvable decisions.

The 57 original PMA decisions comprised 31 approved PMAs, 16 approvable PMAs, and 10 not approvable PMAs. Of the 31 approvals, 5 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 161 days in FY 02 to 151 days in FY 03. The non-FDA component of review time increased from 52 days in FY 02 to 70 days this fiscal year. Thus, the total average review time increased to 221 days from 213 days.

 

Of greater significance to industry is the total elapsed time from submission to decision.
In FY 03, the total average elapsed time for PMA decision cohort performance decreased to 359 days from 364 days in FY 02.

 Figure 2. Original Receipt Cohort PMAs Received and Filed

 

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

 

*First six months

For the first 6 months of FY 03 for PMA receipt cohort performance, the average FDA days from filing to first action increased from 136 in FY 02 to 144 days.

The average FDA (total) elapsed time to an approval or to a denial decreased from 235(313) in FY 02 to 193(215) days in FY 03 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision decreased from 198(300) in FY 02 to 174(218) days in FY 03. All of the statistics of the PMA receipt cohort for FY 03 indicated that we are making decisions faster.

The number of PMA supplements received increased from FY 02’s 645 to 669 in FY 03. There were 739 PMA supplement actions which is down from last year’s 816 total actions. These actions included 6 panel track PMA supplement filing decisions, 98 scientific review decisions, and 635 approval decisions (see Figure 4).

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

 

For PMA supplements reaching final action, the average total review time decreased from 105 days in FY 02 to 93 days in FY 03 (see Figure 5), and the average total elapsed time decreased from 124 days to 111 days.

 Figure 5. Average Review Time for PMA Supplement Decision Cohort
Final Actions

 

There were 4 PMA supplements active and overdue at the end of this fiscal year. The number of active supplements decreased to 123 in FY 03 from 127 in FY 02, and the number of supplements on hold increased from 97 to 111. We received 24 more PMA supplements and are reaching final decisions on fewer, but we are taking an average of 13 less days for the decisions.

For the first 6 months of FY 03 for PMA supplements receipt cohort performance, the first action and final action are as follows. The average FDA days from filing to first action decreased from 71 in FY 02 to 61 days in FY 03. The average FDA (total) elapsed time to an approval or denial decreased from 74(89) in FY 02 to 57(67) in FY 03. The median FDA (total) elapsed time to an approval or denial decreased from 35(43) in FY 02 to 30(36) days in FY 03.

 Real-Time Review of PMA Supplements

A total of 193 requests were received and processed for real time PMA supplements in FY 03 which represents 29% of all supplements received. Of those submissions, 164 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 (49%) followed by DOED (22%), DGRND (11%), OIVD (10%), DRARD (6%), and DAGID (2%). Overall, average review time from receipt to final approval was 44 days.

 Product Development Protocols (PDPs)

No original PDPs were approved in FY 03. Three routine PDP supplements and four “Real Time” PDP Supplements were “approved.” Note that a PDP that has been “declared complete” is considered to have an approved PMA. ODE/OIVD continue 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 03 ODE/OIVD received a total of 30 PMA shells and 73 modules. A total of 17 modules were found to be acceptable while 5 received deficiency letters. Seventeen modules were rolled into PMA review during FY 03 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/OIVD received 10 original HDEs, an increase from 5 received in FY 02. The total number of original HDE actions increased from 23 in FY 02 to 26 in FY 03. These actions included 13 filing decisions, 9 review determinations, 2 approval decisions and 2 other final decisions.

A total of 3 first actions were made this fiscal year, a decrease from 6 made last year. The average time from filing to first action decreased from 53 days in FY 02 to 48 days in FY 03.

Sixty-seven percent of the first actions made in FY 03 occurred within 75 days.

In FY 03, the average elapsed time (from filing to final approval) for original HDEs was 248 days, a decrease from 302 days in FY 02. The average FDA time was 152 days, a decrease from 175 days in FY 02. The average non-FDA time was 96 days, a decrease from 127 days last year.

The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 10. Of these, 4 were 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 to 29 in FY 03 from 16 in FY 02. There were 37 HDE supplement actions in FY 03, up from 27 in FY 02. These actions included 24 approval, 5 approvable, and 6 not approvable decisions.

A total of 29 first actions for HDE supplements were made this fiscal year, an increase from 17 last year. The average time from filing to first action decreased from 53 days in FY 02 to 37 days in FY 03. Ninety percent of the first actions were made within 75 days.

The average elapsed time (from filing to final approval) for HDE supplements increased from 74 days in FY 02 to 95 days in FY 03. The average FDA time decreased from 60 days in FY 02 to 43 days in FY 03. Non-FDA time increased from 14 days in FY 02 to 52 days in FY 03.

The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 11. Of these, 5 were under review and 6 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 03, ODE and OIVD reviewed 309 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/OIVD received 242 original IDEs, a decrease from 312 received in FY 02. There were 246 decisions made on original IDEs, a decrease from 307 last year. One hundred percent of all original IDE decisions were issued within 30 days in FY 03. The average review time was 27 days.

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

* based on those IDE's complete enough to permit substantial review.

Of the original IDEs which were complete enough to support substantive review, the percentage of IDEs approved on the first review cycle decreased from 74% in FY 02 to 65% in FY 03 (see Figure 6).

During this fiscal year, 216 IDE amendments were received. Decisions were made on 217 amendments: 73 approvals (34%); 40 disapprovals (18%); and 104 other administrative actions (48%). One hundred percent of these decisions were made within 30 days.

It took an average total time of 180 days to approve IDEs that were initially disapproved, up from 135 days in FY 02. This average approval time consisted of 68 days for FDA time, the same as last year, and 112 days for non-FDA time, up from 67 days in FY 02.

ODE/OIVD received 4,415 IDE supplements during FY 03. 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 03. The average review time for IDE supplements was 19 days, down from 20 days in FY 02.

 Premarket Notification (510(k)s)

ODE and OIVD received 4,247 original 510(k)s, as well as 1,856 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 1,690 510(k) amendments (additional information received while the 510(k) is under review, the receipt of which does not affect the review clock). Four 510(k)s were granted expedited status.

The total average review time decreased to 96 days in FY 03 from 100 in FY 02, and the average FDA review time was 76 days, down from 79 days in FY 02. 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 72 days in FY 03.

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

There were 1,391 510(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 03 was 376. Most important, for the eighth 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 03 for receipt cohort performance, the FDA time from receipt to final decision was 68 days.

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

*Cut Off Date of 9/30/03 for all receipt cohorts.
**12 month projection based on first 9 months of receipts

For the first 9 months of FY 03 for receipt cohort performance, the total time from receipt to final decision decreased to 73 days.

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

*Cut Off Date as of 9/30/03 for all receipt cohorts.
**For the first 9 months of FY 03. 90th percentile data not available for FY 03.

 Third-Party Review of 510(k)s

During FY 03, ODE and OIVD received 190 510(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 50 percent increase over the 127 submissions received last fiscal year. The increase may be attributable, at least in part, to FDA’s implementation of MDUFMA’s user fee provisions during FY 03 that require applicants to pay a fee when submitting 510(k)s without a third-party review.

ODE/OIVD made final decisions on 169 “third party” 510(k)s in FY 03, an increase from the 132 final decisions in FY 02. The average total elapsed time from a third party’s receipt of a 510(k) to ODE/OIVD’s issuance of a substantial equivalence decision was 74 days, as compared to the average total elapsed time of 112 days for the substantial equivalence decisions on comparable 510(k)s that did not have a third-party review. (This comparison is based on “traditional” and “abbreviated” 510(k)s; “special” 510(k)s are excluded because they typically are not submitted to third parties.) Thus, 510(k)s with a third-party review received marketing clearance 34 percent faster, on average, than comparable 510(k)s reviewed entirely by FDA.

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

 Special 510(k)s

From October 1, 2002 to September 30, 2003 ODE/OIVD received 864 Special 510(k)s out of the 4,247 total number of 510(k)s received. Of these 831 have received final decisions (792 were found substantially equivalent, 7 were found not substantially equivalent, and the remaining 32 had other decisions such as withdrawn or deleted) with the average FDA review time of 28 days and the average total time of 34 days.

 Abbreviated 510(k)s

During this fiscal year, ODE/OIVD received 206 Abbreviated 510(k)s out of the 4,247 total number of 510(k)s received. Two hundred twelve received final decisions (165 substantially equivalent, 3 not substantially equivalent, and 44 other decisions) with a FDA average review time of 96 days and total time of 119 days.

 ODE/OIVD Device Guidance Documents

By the end of this fiscal year, ODE and OIVD issued 26 final guidance documents and issued another 5 drafts for comment. Of the 31 total, 6 were specifically related to MDUFMA (1 Blue Book and 6 Guidance). ODE/OIVD guidance documents issued this year are listed under Part 2 – Industry Information.

Scientifically sound guidance protects and promotes public health by helping ensure manufacturers conduct the correct device performance testing and clinical trials and by enhancing FDA’s ability to review study results, bringing beneficial products to market without undue delay.

Guidance Development Templates

The need for clear science communication in guidance documents and the need for a streamlined procedure for developing certain kinds of guidance documents has led to an exceptionally useful innovation in ODE/OIVD guidance development. In collaboration with the Regulations Staff in the Office of Health and Industry Programs and the FDA Office of Chief Counsel (OCC), ODE/OIVD developed template formats for Class II special controls guidance documents. We have also developed templates for special controls for devices that are exempt from 510(k) and templates for non-special controls guidance documents.

This year, ODE/OIVD also created instructions to authors of guidance, a format for concept papers for guidance developed with the use of templates and other Plain Language materials for science writing in ODE/OIVD.

The use of templates and these associated materials in guidance development has contributed to our efforts to reclassify, more efficiently, numerous preamendments class III devices helping to reduce regulatory burden while still ensuring that the risks to health associated with the device are appropriately addressed in the premarket review. Our efforts in creating templates for special controls guidance documents used in de novo classification have helped ODE/OIVD meet statutory timeframes for these submissions as well.

Risk Management in Guidance Development Templates

Guidance is an effective risk management tool and a critical element of the Commissioner’s Strategic Plan. Moreover, clear, accurate scientific communication in guidance reduces the burden on both industry and FDA. The opportunity to incorporate FDA recognized standards in guidance provides industry and FDA with testing methods and acceptance criteria vetted by experts who represent the international device community, further ensuring clear communication and reducing the burden of regulation. All of ODE’s and OIVD’s guidance development templates focus on addressing the risks to health associated with the use of devices and the measures FDA has identified to mitigate those risks, measures that follow the systems theory approach, by showing how quality systems requirements, premarket review, and postmarket oversight serve together as a system of regulatory controls to assure the safety and effectiveness of devices marketed in the U.S.

 Significant Medical Device Approvals

During FY 03, ODE and OIVD approved 11 PMAs and cleared 8 510(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 October 22, 2002 to classify the Human Dura Mater into class II.
• Published a proposed rule in the Federal Register on March 20, 2003 to classify the Silicone Sheeting into class I exempt from premarket notification.

 Final Classification Actions

• Published a final rule classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instructions, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). [Effective December 16, 2002]
• Published a final rule classifying resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). [Effective July 2, 2003]

 Proposed Reclassification Actions

• Published a proposed rule in the Federal Register on December 13, 2002 to reclassify the arrhythmia detector and alarm from class III (premarket approval) to class II (special controls) based on new information regarding the device. FDA is also proposing to revise the identification of the arrhythmia detector and alarm to separate the automated external defibrillatory (AED) from the identification of the arrhythmia detector and alarm.

 Final Reclassification Actions

• Published a final rule in the Federal Register on December 19, 2002 to reclassify the Adsorbable Polydioxanone Surgical Suture from class III to class II. [Effective July 17, 2002].
• Published a final rule in the Federal Register on December 31, 2002 reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA also reclassified the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls).
• Published a final rule in the Federal Register on March 24, 2003 to reclassify the Knee Joint Patellofemoral Metal/Polymer Porous-coated Uncemented Prosthesis and the Knee Joint Femoraltibial (Unicompartmental) Metal/Polymer Uncemented Prosthesis from class III to class II. [Effective February 3, 2003].

 Automatic Evaluation of Class III Designation

• Issued an order on April 30, 2003 classifying NIOX Breath Nitric Test System into class II CFR 862.3080
• Issued an order on June 16, 2003 classifying Endotoxin Activity Assay into class II CFR 866.3210
• Issued an order on July 8, 2003 classifying West Nile Virus IgM Capture ELISA Assay into class II CFR 866.3940

 513(g) Submissions

Under Section 513(g) of the Federal Food, Drug, and Cosmetic Act, a person can request information about the classification of a device and the regulatory requirements applicable to the device. Within sixty days of the receipt of such a request, the Office of Device Evaluation (ODE) or the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) will provide a written response to such request.

During this fiscal year, ODE and OIVD received 156 513(g) requests for information. ODE and OIVD have responded to 135 of these requests, while reviews of the remaining 21 requests were ongoing.