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FY 2004 ODE Annual Report - Part 5 - Other Program Activities

 ODE Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

During FY 2004, ODE continued efforts to implement the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250.

ODE hired 15 MDUFMA employees in FY 2004: 7 engineers, 5 medical officers, 1 nurse, 1 physicist and 1 microbiologist; and expanded the use of contractors to allow FDA to meet review workloads, strengthen expertise, and improve IT infrastructure. ODE accelerated training of new and existing staff of the new guidance required to implement MDUFMA, and developed training plans to increase clinical and technical training. ODE issued 8 MDUFMA guidances, 6 were level one and 2 were level two-- the 2 level two's were modular and expedited. ODE met all the MDUFMA statutory deadlines for FY 2004 and maintained or improved device review performance in areas not covered by official performance goals. ODE also continued outreach efforts to stakeholders explaining the new requirements and provisions of MDUFMA. This was accomplished through Internet sites to provide MDUFMA information, letters to consumer and trade organizations and manufacturers, a Public Docket, briefings, presentations, and direct responses to phone calls and letters.

The CDRH annual report and the MDUFMA web site (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm) provide more information on performance goals, presentations and reports, guidance documents, and useful reference materials.

 Bioterrorism Preparedness

ODE continues to be involved in several resource-intense initiatives related to national bioterrorism preparedness and response. ODE established liaisons and continues to collaborate with other government agencies and the military to prepare for and assume regulatory responsibilities applicable to medical devices that are critical to bioterrorism preparedness efforts. ODE is currently developing guidance and procedures for timely premarket review and approval of these devices.

 Least Burdensome

The two sections of the Food, Drug, and Cosmetic Act (the act) commonly referred to as the “least burdensome provisions” were enacted by Congress in 1997 to ensure the timely availability of safe and effective new products that will benefit the public and ensure that our Nation continues to lead the world in new product innovation and development. The final document was released on the internet on September 30, 2002 and in the

October 4, 2002 Federal Register (67 FR62252). The guidance may be found on the Center’s website at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htm.

 Study Determination Inquiries

Every year, the Office of Device Evaluation (ODE) receives numerous inquiries regarding the need to submit an IDE application for research involving medical devices. These inquiries are received through a variety of means - in meetings, by telephone, e-mail, fax or letter. Such inquiries are initiated by a wide variety of entities, including device manufacturers, clinical investigators, and IRB members. In order to respond to these inquiries, we may refer to the IDE regulation (21 CFR 812), particularly sections 812.1 (Scope), 812.2 (Applicability), and 812.3 (Definitions), and the FDA Information Sheet entitled, "Significant Risk and Nonsignificant Risk Medical Device Studies" (hereafter referred to as SR/NSR guidance).

Often, the inquiries we receive can be easily answered by referring to the sources identified above. Occasionally, inquiries will present new situations not clearly identified in the regulation or the SR/NSR guidance. A few inquiries involve the scope of the IDE regulation and/or jurisdictional issues that may require consultation with the other FDA centers. An IDE Memorandum (#D01-1) dated, October 26, 2001 was issued to establish written procedures for handling inquiries regarding the need for an IDE application for research involving medical device.

When responding to these inquiries, there are three possible responses: the research is exempt from the IDE regulation; the abbreviated IDE requirements must be met (nonsignificant risk [NSR] study); or the full requirements of the IDE regulation must be met, that is, an IDE application must be submitted to FDA (significant risk [SR] study). In FY 04 ODE received 65 inquires. Of the 65 inquires, there were 11 SR determinations, 30 NSR determinations, 18 exempt determinations, and 3 inquires still under review. One was determined to have CDER jurisdiction, and two others were not pursued after we requested additional information.

 Significant Jurisdictional Issues

 Title 21 of the Code of Federal Regulations Part 3 PRODUCT JURISDICTION describes the procedure the agency uses to assign Center jurisdiction over medical products whose jurisdiction is not clear or is in dispute. Requests for Designations (RFDs) over such products are made in writing to the Office of Combination Products. These formal submissions contain the material describing the requester's product and/or products; a proposal regarding which Center should be given lead designation over their product, and whose authorities (Biological, Device or Drug) should apply.

In FY 04 CDRH participated in the review of 39 out of 51 RFD's received by the FDA's Ombudsman's Office, in addition to completing the reviews of six (6) RFDs received in FY 03. Two (2) RFDs did not require CDRH involvement, two (2) were withdrawn before we started or completed the review of those RFDs and eight (8) RFD’s were never filed and sent to the Centers by OCP. The reviews of the new requests were assigned to the ODE Divisions as follows: DGRND was assigned thirteen (13); DAGID was assigned twelve (12); DRARD was assigned eight (8); DCD was assigned four (4); DOED reviewed three (3) and the remaining RFD was assigned to OIVD to review. The number of Division RFD reviews exceeded the total number of RFDs as several required multiple Division review.

Of the 45 RFD’s [39 assigned in FY 04 and the 6 carry over from FY 03] which CDRH completed reviews during FY 04:

- CDRH was assigned the lead center in 25 of those requests
- CDER was assigned lead center in 9

- CBER was designated lead in 4 RFDs
- Two (2) were assigned to Dual (CDRH and CDER) Center Leads

Five (5) RFDs were not due for completion until FY 05.

  Transmissible Spongiform Encephalopathy (TSE)

ODE continues to be actively involved in agency and CDRH TSE activities. ODE in coordination with other CDRH offices, CBER, CDER and CFSAN has worked to develop regulations to add further safeguards in the selection of bovine materials used in medical products. Along with CDRH and these other centers, ODE has participated in the Center for Biologics February and July 2004 FDA CBER TSE Advisory Committee (TSEAC) meetings. The ODE presentation for CDRH at the February 2004 TSEAC meeting provided an update that there were no medical devices that have been cleared or approved that claim the ability to remove or detect TSE contamination.

ODE has held been active in the monthly CDRH TSE Working Group meetings where CDRH meetings, issues and concerns are discussed to maintain communication among the center experts.

 Advisory Panel Activities

The Center’s Medical Devices Advisory Committee (MDAC) with its 18 panels provides clinical and scientific advice to FDA in a number of areas fundamental to the regulation of medical devices. The primary areas of activity are: (1) review and recommendations on premarket submissions, primarily Premarket Approval Applications (PMAs), and 510(k)s, (2) classification and reclassification of medical devices based on risk to patients, (3) advice on guidance documents that provide industry and FDA staff with expectations for studies and data for premarket reviews, and (4) input on new issues or questions concerning the determination of the safety or effectiveness of medical devices.

In FY04, ODE held twenty-one panel meetings. These panels reviewed and made recommendations on twenty PMAs, one 510(k), two reclassification petitions, and three general issues. In FY04 there were 20 training sessions for new panel members and consultants. The panels reviewed PMAs for significant device breakthrough technologies such as a computed tomography (CT) computer aided detector (CAD) device for detecting solid pulmonary nodules, a magnetic resonance imaging (MRI) guided uterine fibroid focused ultrasound ablation system and a total artificial heart for use as a bridge to transplant for patients in imminent risk of death.

CDRH continuously recruits and selects highly qualified experts to serve as members and consultants on these panels. Potential candidates are asked to provide detailed information concerning financial holdings, employment as well as research grants and contracts to identify any potential or imputed conflicts of interest. Interested individuals should send their curriculum vitae to njp@cdrh.fda.gov.

The MDAC panels are key to ensuring that the agency has access to the nation’s esteemed medical and scientific experts and to making the FDA medical device review process transparent to stakeholders. The Office of Device Evaluation greatly appreciates the significant contributions that the advisory panel members and consultants make to the ongoing medical device review process.

 ODE Integrity Program

During this fiscal year, ODE/OIVD considered about 58 cases concerning the integrity of data submitted to the agency in premarket applications. Under the Application Integrity Program (AIP), three firms were placed on the AIP list and AIP restrictions applied against these firms. An Integrity Hold was placed on three firms’ applications during FY 04, and we removed one application from Integrity Hold.

ODE handled 25 instances related to questions arising under the standards of conduct for employees. During FY 04, as in years past, the ODE/OIVD staff received several unsolicited gifts from the regulated industry. Both the offering of gifts and their acceptance in general, are prohibited under applicable laws and regulations. The regulated industry, their agents and representatives should not send gifts to staff members. See Standards of Ethical Conduct for Employees of the Executive Branch on the internet at