FY 2004 ODE Annual Report - Part 3 - Key Performance Indices
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 ActionsFigure 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
ODE Device Guidance Documents
Guidance Development Templates
Risk Management in Guidance Development Templates
Significant Medical Device Approvals
Proposed Classification Actions
Final Classification Actions
Proposed Reclassification Actions
Final Reclassification Actions
Automatic Evaluation of Class III Designation
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. Historically, the ODE Annual Report has included combined data for both ODE and OIVD. However, the FY04 Annual Report includes predominately ODE data. The Tables and Figures here and the Tables in Part 7- OPERATIONAL STATISTICS now include two columns of information – OVID/ODE and ODE Only for FY04. 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).
ODE ended FY 2004 with 314 employees. During the year, ODE lost 45 employees (16 scientific reviewers, 10 medical officers, 2 clerical and 2 program analyst/administrative officers, 4 interns, 11 contractors) through resignation, reassignment or retirement and added 41 new employees (15 scientific reviewers, 7 medical officers, 7 paid student interns and 12 contractors).
During FY 04, ODE received 8,436 major submissions. [See Table 1 for a breakdown of major submissions received.]
|TYPE OF SUBMISSION|
OIVD / ODE
On the decision side, ODE completed the processing of 8,573 major submissions. [See Table 2 for major submissions completed.]
|TYPE OF SUBMISSION|
OIVD / ODE
ODE received 37 original PMAs. The total number of PMAs in inventory (active and on hold) at the end of this fiscal year was 70. The number of active PMAs under review at the end of FY 04 was 27 and there were 43 on hold.
The total number of PMA actions was 198. These actions included 44 filing decisions, 102 scientific review decisions, and 52 approval/approvable/not approvable decisions.
The 52 original PMA decisions comprised 30 approved PMAs, 15 approvable PMAs, and 7 not approvable PMAs. Of the 30 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 was 155 days in FY 04. The non-FDA component of review time was 73 days this fiscal year. Thus, the total average review time came to 228 days.
FY 04* ODE/OIVD
FY04** ODE Only
Of greater significance to industry is the total elapsed time from submission to decision. In FY 04, the total average elapsed time for PMA decision cohort performance was 436 days.
*first six months
FY 04* ODE/OIVD
FY04** ODE only
*First six months
FY04** ODE Only
For the first 6 months of FY 04 for PMA receipt cohort performance, the average FDA days from filing to first action was 113 days.
The average FDA (total) elapsed time to an approval or to a denial was 176(215) days in FY 04 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision was 177(220) days in FY 04. All of the statistics of the PMA receipt cohort for FY 04 indicated that we are making decisions faster.
The number of PMA supplements received came to 565 in FY 04. There were 639 PMA supplement actions. These actions included 7 panel track PMA supplement filing decisions, 81 scientific review decisions, and 551 approval decisions (see Figure 4).
For PMA supplements reaching final action, the average total review time was 86 days in FY 04 (see Figure 5), and the average total elapsed time was 106 days.
There were 4 PMA supplements active and overdue at the end of this fiscal year. The number of active supplements totaled 106 in FY 04, and the number of supplements on hold came to 94.
For the first 6 months of FY 04 for PMA supplements receipt cohort performance, the first action and final action are as follows. The average FDA days from filing to first action was 55 days. The average FDA (total) elapsed time to an approval or denial was 55(62). The median FDA (total) elapsed time to an approval or denial came to 30(30) 30(30) days in FY 04.
A total of 178 requests were received and processed for real time PMA supplements in FY 04 which represents 31% of all supplements received. Of those submissions, 147 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 (60%) followed by DOED (16%), DGRND (14%), DRARD (7%), and DAGID (3%). Overall, average review time from receipt to final approval was 53 days.
One original PDP was approved in FY 04. Three routine PDP supplements and six “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.
For FY 04 ODE received a total of 21 PMA shells and 65 modules. A total of 4 modules were found to be acceptable while 10 received deficiency letters. Seven modules were rolled into PMA review during FY 04 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.
ODE received 9 original HDEs. The total number of original HDE actions 38 in FY 0 04. These actions included 8 filing decisions, 18 review determinations, 5 approval decisions and 5 other final decisions.
A total of 7 first actions were made this fiscal year. The average time from filing to first action was 52 days in FY 04.
One hundred percent of the first actions made in FY 04 occurred within 75 days.
In FY 04, the average elapsed time (from filing to final approval) for original HDEs was 287 days. The average FDA time was 195 days. The average non-FDA time was 92 days.
The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 8. Of these, 4 were under review and 3 were on hold. There was 1 active HDE that was overdue at the end of the fiscal year.
The number of HDE supplements received was 28 in FY 04. There were 39 HDE supplement actions in FY 04. These actions included 22 approvals, 6 approvable, and 3 not approvable decisions.
A total of 37 first actions for HDE supplements were made this fiscal year. The average time from filing to first action was 36 days in FY 04. Forty-nine percent of the first actions were made within 75 days.
The average elapsed time (from filing to final approval) for HDE supplements was 90 days in FY 04. The average FDA time was 61 days in FY 04. Non-FDA time was 29 days in FY 04.
The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 11. Of these, 7 were under review and 4 were on hold. There were no active HDE supplements that were overdue at the end of the fiscal year.
During FY 04, ODE reviewed 378 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 222 original IDEs. There were 217 decisions made on original IDEs. One hundred percent of all original IDE decisions were issued within 30 days in FY 04. The average review time was 28 days.
* 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 was to 74% in FY 04.
During this fiscal year, 167 IDE amendments were received. Decisions were made on 162 amendments: 61 approvals (38%); 27 disapprovals (17%); and 74 other administrative actions (46%). One hundred percent of these decisions were made within 30 days.
It took an average total time of 161 days to approve IDEs that were initially disapproved. This average approval time consisted of 61 days for FDA time, the same as last year, and 100 days for non-FDA time.
ODE received 4,298 IDE supplements during FY 04. 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 04. The average review time for IDE supplements was 19 days.
ODE received 3,110 original 510(k)s, as well as 1,787 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 1,408 510(k) amendments (additional information received while the 510(k) is under review, the receipt of which does not affect the review clock). One 510(k) was granted expedited status in FY 04.
The total average review time was 100 days in FY 04, and the average FDA review time was 74 days. The median review time, i.e., the time it took to review 50% of the 510(k)s, was 70 days in FY 04.
**ODE / OIVD
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 04 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 04 for receipt cohort performance, the FDA time from receipt to final decision was 57 days ODE/OIVD and 58 days for ODE only.
+Cut Off Date of 9/30/04 all receipt cohorts
*ODE / OIVD
** ODE Only
For the first 9 months of FY 04 for receipt cohort performance, the total time from receipt to final decision decreased to 65 days ODE/OIVD and 65 days for ODE only.
*Cut Off Date as of 9/30/04 for all receipt cohorts.
**For the first 9 months of FY 04. 90th percentile data not available for FY 04.
During FY 04, ODE and OIVD received 255 510(k)s (242 and 13, respectively) reviewed by third-party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. This was a 34 percent increase over the 190 submissions received last fiscal year, and more than twice the 127 submissions received in FY 02. The increase may be attributable, at least in part, to FDA’s implementation of MDUFMA’s user fee provisions during FY 2003 that require applicants to pay a fee when submitting 510(k)s without a third-party review.
ODE and OIVD made final decisions on 244 “third party” 510(k)s in FY 04 (231 and 13, respectively), an increase from the 169 final decisions in FY 03.
CDRH took steps during FY 04 to improve the quality and consistency of third party reviews and facilitate ODE’s and OIVD’s timely action on these submissions. In March 2004, CDRH initiated quarterly telephone conferences with all third parties to provide a routine forum for discussing issues and answering questions. On September 28, 2004 , the Center issued an updated guidance document on conducting and documenting third party reviews (see Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications). The Center also arranged training sessions for ODE/OIVD staff and third party reviewers, scheduled for October 22, 2004 in Rockville , Maryland and October 26-27, 2004 in Gaithersburg , Maryland , respectively.
Information on the 510(k) Accredited Persons Program is available on the Center’s third party web page at Third Party Review.
From October 1, 2003 to September 30, 2004 ODE received 720 Special 510(k)s out of the 3,110 total number of 510(k)s received. During the fiscal year 748 have received final decisions (720 were found substantially equivalent, 4 were found not substantially equivalent, and the remaining 24 had other decisions such as withdrawn or deleted) with the average FDA review time of 30 days and the average total time of 40 days.
During this fiscal year, ODE received 110 Abbreviated 510(k)s out of the 3,110 total number of 510(k)s received. One hundred twenty-seven received final decisions (101 substantially equivalent, 6 not substantially equivalent, and 20 other decisions) with a FDA average review time of 86 days and total time of 119 days.
By the end of the fiscal year, ODE issued 26 final guidance documents and issued another 56 drafts for comment. Of the 30 total, 8 were specifically related to MDUFMA. ODE 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.
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 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 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 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.
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 meet statutory timeframes for these submissions as well.
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 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.
During FY 04, ODE approved 8 PMAs and cleared 7 510(k)s that represent significant medical device breakthroughs. See Part 2 - INDUSTRY INFORMATION, Significant Medical Device Approvals - for a complete listing.
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.
- Published a proposed rule in the Federal Register on March 17, 2004 to classify external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II. Also, FDA is giving notice of its intent to exempt this type of device from premarket notification.
- Published a final rule classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (exempt). [Effective August 9, 2004 ]
- Published a final rule requiring the filing of a premarket approval application or a notice of completion of a product development protocol for three class III preamedment devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. [Effective June 23, 2004 ].
- Published a final rule classifying Human Dura Mater intended to repair defects in human dura mater into class II. [Effective January 20, 2004 ].
- Published a final rule classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. [Effective January 2, 2004 ].
- Published a proposed rule in the Federal Register on February 25, 2004 to reclassify the Vascular Embolization Device and the Neurological Embolization Device into Class II.
- Published a proposed rule in the Federal Register on June 30, 2004 to reclassify tricalcium phosphate (TCP) granules for dental bone repair from class III to class II; classify into class II all other bone grafting material for dental indications, except those that contain a drug or biologic components; and revise the classification name and identification of the device. Bone grafting materials that contain a drug or biologic component would remain in class III.
- Published a final rule in the Federal Register on May 12, 2004 to reclassify Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments from class III to class II [Effective June 11, 2004 ].
- Published a final rule in the Federal Register on October 28, 2003 to reclassify arrhythmia detector and alarm devices from class III to class II. [Effective November 28, 2003 ].
- Issued an order on June 25, 2004 classifying Celleration MIST Therapy System into class II 878.4410.
- Published a proposed rule on March 5, 2004 for the Effective Date of the Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/polymer Semi-constrained, Resurfacing Cemented Prosthesis; Opportunity to request a change in classification.
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) will provide a written response to such a request.
During this fiscal year, ODE received 240 513(g) requests for information. ODE has responded to 187 of these requests, while reviews of the remaining 53 requests are ongoing.