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U.S. Department of Health and Human Services

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OCD FY2003: Medical Device User Fee and Modernization Act (MDUFMA) Implementation

Medical Device User Fee and Modernization Act

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), amends the Federal Food, Drug, and Cosmetic Act (the Act) to provide FDA important new responsibilities, resources, and challenges. The Act has three particularly significant provisions:

  • User fees and performance goals for premarket reviews of PMAs, PDPs, premarket reports (a new category of premarket application for reprocessed single-use devices), certain supplements, and 510(k)s. These fees, together with additional appropriations, will allow FDA to make significant improvements to review evaluation processes, reducing the time required to make new medical technologies available to health care professionals and patients.
  • Establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions.
  • New regulatory requirements for reprocessed single-use devices, including a new category of premarket submission, the premarket report.

Other important provisions of the new law include:

  • The third-party 510(k) review program is continued through FY 06.
  • The review of combination products will be coordinated by FDA’s new Office of Combination Products.
  • Electronic labeling is authorized for prescription devices used in health care facilities. The law now explicitly provides for modular review of PMAs.
  • New provisions are added concerning devices intended for pediatric use.
  • The manufacturer of a device must be identified on the device itself, with certain exceptions.

FDA met all the MDUFMA statutory start-up dates in FY 03.

Additional background on MDUFMA, including the full text of the law, a plain-language summary, links to MDUFMA guidance documents and Federal Register notices, and other reference materials is available on CDRH’s Internet site (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm).

Implementation of MDUFMA

  • Consultation and communication with stakeholders. - A key feature of FDA’s implementation of MDUFMA has been the degree to which stakeholders have had the opportunity to provide their views on FDA’s implementation of the new law’s complex provision. CDRH established Internet sites to provide MDUFMA information, sent letters to consumer organizations, trade organizations, and manufacturers about MDUFMA (CDRH’s site is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm), gave briefings and presentations at numerous professional meetings (including a nationwide teleconference), and responded to hundreds of phone calls and letters concerning MDUFMA’s new requirements. To help to ensure that the guidance and regulations CDRH issues to implement MDUFMA achieve their objectives without imposing unnecessary burdens, CDRH established an open public docket to receive comments from the stakeholders, and invited comment on specific proposals and actions in numerous Federal Register notices. CDRH will be working to build on and expand these efforts during the coming year.
  • Collaboration with CBER and OCP - CDRH has been working closely with the Center for Biologics Evaluation and Research and FDA’s new Office of Combination Products to ensure a smooth implementation of MDUFMA. CDRH has adopted uniform definitions and uniform performance measures, and has carefully coordinated Internet postings to help ensure stakeholders can find the information they need.

MDUFMA Review Performance Goals in Effect During FY 03

MDUFMA user fees and additional appropriations will allow FDA to add essential resources to device review programs. In conjunction with these new resources, MDUFMA also requires FDA to pursue a comprehensive set of challenging review performance goals. These goals are defined in a letter from DHHS Secretary Thompson to Congress.

  • Measurable Goals - MDUFMA’s review performance goals recognize that FDA will need a two-year implementation period (FY 03 - FY 04) to hire and train new staff and rebuild review program infrastructures before it will be possible to show substantial progress in overall review performance. Consequently, most of MDUFMA’s measurable performance goals do not go into effect until FY 05. Two measurable goals were in effect during FY 03:
    ­ For original premarket approval (PMA), panel-track PMA supplement, and premarket report submissions, 90% of amendments containing a complete response to an approvable letter will be acted on within 30 days.
    ­ For expedited PMAs, 90% of amendments containing a complete response to an approvable letter will be acted on within 30 days.

During FY 03, the first year of the MDUFMA program, there was no opportunity to apply either of these performance goals because the conditions required did not occur before FY 03 ended. That is, there was no instance where:

­ An applicant submitted an application on or after October 1, 2002 (the effective date of MDUFMA’s review performance goals), and
­ FDA issued an “approvable” letter for that application, and
­ The applicant submitted an amendment containing a complete response to FDA’s “approvable” letter, and
­ 30 days passed for FDA to take action on the amendment, and
­ The 30-day period for FDA action closed before the end of FY 03.

This does not indicate a problem with either the PMA or expedited PMA review processes. CDRH often approves a PMA without first issuing an “approvable” letter; for example, during FY 03, CDRH approved seven original PMAs without issuing an “approvable” letter, and found four additional original PMAs approvable subject to GMP inspection (this action is defined as an FDA decision by the performance goals agreed to for MDUFMA).

Additional Actions to Meet MDUFMA’s Review Performance Goals

  • Use of formal and informal meetings - CDRH encourages meetings as a particularly effective way to ensure that both FDA and applicants understand the clinical, scientific, and technical issues both parties are seeking to resolve. During FY 03, CDRH tracked four types of meetings: pre-IDE meetings, determination meetings, agreement meetings, and 100-day meetings. The pre-IDE meetings have proven to be the most useful to applicants; during FY 03, FDA participated in 99 pre-IDE meetings. The other types of meetings have proven to be of less interest to applicants.
  • Maintenance of current performance in review areas where specific performance goals have not been identified - Final results for FY 03 are not yet available for all types of submissions (the FY 03 receipt cohort remains open for many types of submissions), but the available data indicate the timeliness of medical device reviews not covered by a specific performance goal was comparable to, or better than, results for FY 02.
  • Application of user fee revenues to support reviewer training and hiring and use of contract expertise. During FY 03, CDRH filled 75 new positions for MDUFMA implementation, including scientists, engineers, project managers, statisticians, medical officers, review supervisors, and administrative support. CDRH also expanded use of contractors to provide additional flexibility to meet nonrecurring workloads and to supplement staff expertise in highly-specialized areas. FY 03 hiring efforts were delayed because CDRH could not hire new staff until FDA’s appropriation for FY 03 was enacted; this did not occur until February 20, 2003. Prior to that time, FDA did not have funds available to hire new staff and CDRH had to rely on existing staff to implement MDUFMA. CDRH implementation of MDUFMA accelerated during the second half of FY 03, as it was able to begin hiring and training new staff.
  • Modular PMA Reviews - FDA issued initial guidance on modular PMA reviews in “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products”, issued on February 25, 2003. The guidance explains that the fee for a modular PMA submission is due upon submission of the first module (not just the “shell” that describes the overall plan for the modular submission). If an applicant submitted the first module (again, not just the shell) prior to the October 1, 2002 effective date of MDUFMA, no fee will be required. (Note: On November 3, 2003, CDRH issued the final guidance, “Premarket Approval Application Modular Review”.) During FY 04, CDRH will consult with stakeholders to develop performance goals for modular PMAs.
  • Bundling Policy. - After consulting with stakeholders, FDA determined that bundling is appropriate in the right circumstances. CDRH issued initial guidance on bundling of multiple related submissions in the guidance document, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products”, issued on February 25, 2003. This guidance explains that bundling may involve multiple devices or multiple indications for use. After issuing this preliminary guidance, CDRH continued to consult with stakeholders, and as a result it was able to provide more comprehensive guidance on bundling early in FY 04 (on November 26, 2003, FDA issued the final guidance, “Bundling Multiple Devices or Multiple Indications in a Single Submission”).
  • Electronic Review of Applications - CDRH worked with applicants to expand the use of electronic submissions during FY 03; 29 sponsors sent 101 submissions entirely in electronic form (compared with 14 sponsors and 73 submissions during FY 02). CDRH will continue to expand use of electronic submissions as resources permit.
  • Preapproval Inspections - During FY 03, FDA began an examination of the factors affecting the timeliness of preapproval inspections to determine how the process can be improved and what resources would be required to make those improvements. During FY 04, FDA expects to commit to specific performance goals for preapproval inspections, and CDRH will begin making the process improvements necessary to achieve those goals.
  • Third-Party Establishment Inspections - Pursuant to the new section 704(g) of the FD&C Act, establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions. CDRH determined and published the criteria it will use to accredit third-parties, and invited interested persons to apply. During FY 04, CDRH will train auditors for the first 15 accredited persons (it accredited these persons on October 24, 2003), and third-party inspections will begin.
  • New Safeguards for Reprocessed Single-Use Devices – The new section 502(v) of the FD&C Act establishes new regulatory requirements for reprocessed single-use devices, including provisions requiring the submission of additional validation data concerning the safety and effectiveness of devices now being reprocessed. MDUFMA also creates a new category of premarket submission, the premarket report (essentially, a PMA for a reprocessed single-use device). CDRH published a Federal Register notice on April 30, 2003 that provides a list of reprocessed single-use devices for which validation data is now required and a list of critical devices whose exemption from premarket notification is revoked and for which validation is now required. It will take similar action concerning semi-critical devices during FY 04.

New MDUFMA Provisions

  • Pediatric expertise on FDA advisory panels - MDUFMA amended section 515© of the FD&C Act to require, where appropriate, that an FDA advisory panel shall include, or consult with, one or more pediatric experts. On June 3, 2003, CDRH issued the guidance, “Pediatric Expertise for Advisory Panels”. This guidance defines pediatric populations, discusses the circumstances that indicate pediatric expertise should be employed by a panel, and explains the responsibilities of review team leaders and panel executive secretaries in identifying the need for pediatric expertise and making such expertise available.
  • Protection of children who participate in clinical trials or who use, or are treated with, medical device. Section 213 of MDUFMA requires FDA to issue guidance, within 270 days of enactment, on:
    - Information necessary to assure the safety and effectiveness of devices used in the pediatric population.
    ­ Protection of children who participate in clinical trials of devices.

    On July 24, 2003, FDA issued a draft guidance, “Premarket Assessment of Pediatric Medical Devices”. The draft guidance defines pediatric population subgroups and pediatric use for medical devices and device clinical trials, discusses the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in the pediatric population, and discusses the protections sponsors should consider for pediatric subjects in device clinical trials.

  • Electronic labeling - New section 502(f) of the FD&C Act authorizes electronic labeling for prescription devices intended to be used in health care facilities. The objective is to provide health care professionals with current labeling more rapidly, and at a lower cost, than would otherwise be possible. If a health care facility wants traditional paper labeling, it must be provided at no additional cost. CDRH will publish guidance on electronic labeling during FY 04.
  • Identification of manufacturer - New section 502(u) of the FD&C Act requires identification of the manufacturer of a device in the device itself, with certain exceptions. This requirement goes into effect April 26, 2004 (18 months after enactment of MDUFMA). FDA received many comments that this time frame presents insurmountable difficulties to many manufacturers, and after careful consideration FDA issued draft guidance advising that CDRH would exercise enforcement discretion and does not intend to object if a manufacturer has not yet fully implemented the requirements of section 301 for up to 18 months after FDA issues final guidance.
  • Identification of reprocessor - New section 502(v) of the FD&C Act requires reprocessed single-use device to “prominently and conspicuously” bear the statement:

     

    Reprocessed device for single use. Reprocessed by
    [name of manufacturer that reprocessed the device].

    This requirement goes into effect January 26, 2004 (15 months after enactment of MDUFMA).

Technical Corrections to MDUFMA

The Medical Devices Technical Corrections Act (MDTCA), P.L. 108-214 amends and expands upon the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The President signed MDTCA into law on April 1, 2004.
The purposes of MDTCA essentially parallel those of MDUFMA. MDTCA clarifies some potentially confusing language in MDUFMA, modifies important features of the provisions providing for third-party inspections, expands the provision for electronic labeling, delays the effective date of section 502(o) of the FD&C Act (section 301of MDUFMA, requiring a device to “prominently and conspicuously” bear the name of its manufacturer), and requires FDA to prepare and submit to Congress a report on barriers to the availability of devices intended for children.

  • Key Provisions. - MDTCA makes important changes to MDUFMA in three areas:
    ­ Changes to the third-party inspection program.
    ­ Expansion of the provision for electronic labeling.
    ­ Delays the effective date of new section 502(o) of the FD&C Act until October 26, 2005 (36 months after enactment of MDUFMA, and 18 months beyond the original effective date set by MDUFMA).
  • Additional Changes -MDTCA makes many other technical corrections and clarifications, mostly minor. For additional information on MDTCA, see the MDUFMA website, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.