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Summary of MDUFMA FY 04 Notices and Reports

• For the year of 2004; four reports are due to Congress:
• Annual report to Congress on the “timeliness and effectiveness” of device reviews by centers other than CDRH.  Completed August, 2003
• Annual report to Congress on the Office created to coordinate and monitor the review of combination products. Completed October, 2003
• Annual Financial Report to Congress
  Completed March 10, 2004
• Annual Performance Report to Congress
  Completed April 23, 2004
• One public meeting was held on December 3, 2003.
• One notice is due to the Federal Register on April 26, 2004 reviewing the types of semi-critical reprocessed single-use devices currently 510(k) exempt, and determine which exemptions will be terminated.
• 510(k)s are required by July 30, 2004 for critical reprocessed single use devices whose exemption from 510(k) has been revoked.
• Fees for FY 2005 are to be published in the Federal Register by August 2, 2004.
  

FY04 Increase in Fees

• In FY 2003, the statutory revenue target for MDUFMA fees was $25,125,000. This increased by $2,130,000 to $27,255,000 in FY 2004
• An Inflation Adjustment of $1,163,789 (Federal pay raise for employees in the Washington DC area was 4.27% the most recent year.)
• A Compensating Adjustment (estimated in July 2003) to compensate for an unforeseen revenue shortfall in FY 2003 of $5,478,000 below the MDUFMA revenue target of $25,125,000 for FY 2003.
• This adjustment was revised after October 1, 2003, when actual revenue for FY 2003 was somewhat higher than the June estimate, so that the actual compensating adjustment was lowered to $3,235,418.
  

Revised FY 2004 Revenue Target

Fees for Large and Small Businesses

Total Fees Collected in the Second Quarter of FY 04

MDUFMA Authorized New Hires in CDRH and CBER for FY 03 and 04

*CBER data presented as FTEs

CDRH Authorized 65 Additional MDUFMA Hires in FY 04

• 65 CDRH Authorized MDUFMA FY 04 Hires
• 23 Completed MDUFMA Hires 4/17/04

CDRH MDUFMA Hiring by Category FY 03 and the First Six Months of FY 04

CDRH Hiring and Losses FY 2003 - 04

[Link for Accessibility]

CDRH MDUFMA Device Review Process FTEs

CDRH MDUFMA Device Review Process FTE's

CBER/CDRH Collaborations are Productive and Increasing

• Joint CDRH-CBER Training Courses
• CDRH-CBER review collaborations
  -Bi-directional
• Orthopedic Working Group
• Policy (in addition to previously mentioned)
  - Genomics
  - Xenotransplantation
  - IVD total product life cycle labeling
  - Software
• MATES, other tissue engineering efforts

Effort and Expertise in the Reinvention of CBER Device Management and MDUFMA

• CBER has substantially (~ 25%) increased device related effort in the last year
• In addition to increased device effort from employees, new hiring has allowed recruitment of individuals with specialized experience/expertise and diverse backgrounds - examples
  - reviewers with specific device/device related software experience (1 from industry, 1 IT)
  - RPMs with industry manufacturing experience
  - reviewers with clinical/academic experience in blood banking, transfusion medicine, apheresis

CDRH Medical Device Fellowship Program

• What do participating clinicians do?
  - Work as part of a team
  - Evaluate and consult on clinical trial design
  - Provide clinical consults (formal and informal)
  - Participate in meetings and conferences
  - Represent CDRH at industry meetings
  - Assist in developing guidance documents

CDRH Medical Device Fellowship Program FY 04 2nd quarter

• Physicians - 8 currently; 3 new in 2nd qtr
  - Visiting Scholar – senior level clinicians, surgeons
  - Fellow - physician during fellowship training
  - Resident – physician during residency training

• Engineers 15 currently; 6 new in 2nd qtr
  - Visiting Scholar – senior level engineer
  - Co-op students
  - Interns

• Others 3 currently; 0 new in 2nd qtr
  

Contact information:
Susan A. Homire, D.V.M.
301-827-2890
sah@cdrh.fda.gov

Small Buisness Decisions

Income Distribution of 365 Device Firms Requesting Small Busniess Determinations from FDA

Through Second Quarter of FY 04 (Oct. 1, 2003 - March 31, 2004)

What do the Goals Mean?

• Some goals are simply a reflection of statutory requirements
• Some goals are for pieces of the process that when added together should result in a better whole
• Some goals reflect significant changes which will bring new products to market faster
  

MDUFMA Decision Goals

Performance Updates for MDUFMA Decision Goals with CDRH and CBER Data FY 03 Receipt Cohort
(as of 3/31/04)

Expedited PMAs with Decisions within 300 total FDA days

Performance Updates for MDUFMA Decision Goals with CDRH and CBER Data FY 03 Receipt Cohort
(as of 3/31/04)

Original PMAs and PMA Panel Track Supplements with decisions within 320 total FDA days

Performance Updates for MDUFMA Decision Goals with CDRH and CBER Data FY 03 Receipt Cohort
(as of 3/31/04)

180 Day PMA Supplements with decisions within 180 total FDA days

Performance Updates for MDUFMA Decision Goals with CDRH and CBER Data FY 03 Receipt Cohort
(as of 3/31/04)

510(k) Applications with final action within 90 total FDA days

Performance Updates for Selected MDUFMA Cycle Goals with CDRH and CBER Data FY 03 Receipt Cohorts (as of 3/31/04)

Performance Updates for MDUFMA BLA Efficacy Supplements

Goal: First action within 10 months total FDA time

Performance Updates for MDUFMA BLA Prior Approval Manufacturing Supplements

Goal: First action within 4 months total FDA time

CDRH has 23 Standard and Expedited PMA Originals and Panel Track Supplements Under Review in its FY 04 Receipt Cohorts (as of 4/13/04)

[Link for Accessibility]

6 Month Summary of FY 04 MDUFMA Receipt Cohorts in CDRH (as of 3/31/2004)

FDA is not reporting performance on MDUFMA decisions for the FY 04 receipt cohorts in the second quarter report
because not enough time has unfolded for meaningful performance to report.
FDA will report on the data in this chart in the third quarter.

MDFMA Guidances Issued in First Six Months of FY 04

• PMA Performance Assessment guidance:10/08/2003

• PMA Modular review- Guidance for Industry and FDA:11/03/2003

• Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications: 11/24/2003
  
• Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices :11/26/2003

• Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission: 11/26/2003

15 Total MDUFMA Guidances Issued Since MDUFMA Passed.

MDUFMA Requirements
Section 510(o)

• New provision amended FD&C Act to ensure that certain reprocessed SUDs to be determined by FDA must include validation data

• Validation data includes cleaning, sterilization & functional performance data demonstrating substantial equivalence

What FDA Has Done So Far …

• 4/30/2003: FR Notice – Reprocessed SUDs: Termination of exemptions from premarket notifications: requirements for submission of validation data
  • List 1: Critical reprocessed SUDs previously exempted from 510(k) that will require 510(k) validation data (total:15 categories)
  • List 2: Reprocessed SUDs that will now require submission of validation data (total:51 categories)

What is the Purpose of Third Party Inspection?

• FDA will have greater flexibility to use its limited inspectional resources
• Industry will have ability to schedule AP and other conformity assessment body (CAB) inspections simultaneously
• 14 Third Party Inspectors are accredited (15 accredited, and one withdrew)
• List of 14 Third Party Inspectors http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html#list

Primary Features of Program

• Eligible Establishment:
  • Selects AP from list
  • Negotiates fee (not funded by FDA)
  • Makes request to FDA to use AP
• Very strict conflict of interest provisions
• No effect on US/EC MRA or other agreements
• Assess the Quality System (Q.S.) of eligible Class II and Class III manufacturers
• Determine compliance with other requirements, e.g. MDR
• Pre-approval, BiMo and “For Cause” inspections conducted exclusively by FDA
• Prepare and submit reports to FDA
  

Updated June 7, 2004

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