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FY 2002 ODE Annual Report - Part 5 - Other Program Activities

Guidance for Industry and Reviewers
Least Burdensome
Bioterrorism Preparedness
Study Determination Inquiries
Significant Jurisdictional Issues
CLIA Activities
Advisory Panel Activities
ODE Integrity Program

 Guidance for Industry and Reviewers

In FY 02, ODE published 15 final guidance documents and published 9 draft guidance documents for comment. See INDUSTRY INFORMATION for a complete listing of all ODE guidance documents published in FY 02.

 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. During the last few years, CDRH has been working with its stakeholders to develop an interpretation of the least burdensome provisions. In the May 3, 2001, Federal Register, the draft guidance document entitled, “The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles” was released for comment. While the agency received very few comments on the draft, almost all of them strongly supported the guidance and encouraged full implementation of it as soon as possible. Several comments recommended that FDA develop a training program for its staff as well as ways to assess both the Agency’s success in implementing the principles and the stakeholders’ satisfaction with FDA’s incorporation of them into its daily activities. The agency agreed with these recommendations and has incorporated them into the final guidance. 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.

 Bioterrorism Preparedness

ODE continues to be involved in several resource-intense initiatives related to national bioterrorism preparedness and response. ODE established liaison and continues collaboration with other government agencies and the military to prepare for and assume regulatory responsibilities applicable to in vitro diagnostic products and other 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.

During this year, the Division of Clinical Laboratory Devices (DCLD) convened a classification panel to recommend classification of IVD products for the identification/detection of B. anthracis and Y. pestis. As a result of this panel, DCLD is developing notices of proposed rulemaking (NPRM) describing the proposed classification of these devices, and guidance containing the types of information needed to assess premarket submissions of the devices FDA is proposing to classify. DCLD is also working on the NPRM that proposes an amendment to the exception from general requirements for informed consent to apply in certain circumstances when investigational IVDs are used to identify agents potentially associated with terrorism threats.

In addition, DCLD continues interacting with manufacturers involved in the development and data gathering on devices for the identification of bioterrorism threat agents. This year DCLD has met or communicated by phone with several companies to clarify the premarket review requirements and routes available to obtain clearance or approval for medical uses, including investigational uses. Our scientists have participated in discussions with industry, the CDC and the military in determining options for making new in vitro diagnostic devices available and in clarifying requirements for testing during the investigational phase of the products.

The Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (DAGID) evaluated a modification of a device intended for use by the military to remove chemical agents from clothing and skin. It also began discussions with another applicant on a device intended for the same use but employing a different formulation. DAGID evaluated submissions during the fiscal year on liquid chemical agents, ultraviolet light air purifiers, and sterilizers that could be used to decontaminate surfaces and products.

The Division of Cardiovascular Devices (DCD) has been involved in the Ad Hoc Committee on Device Shortage for Bioterrorism Preparedness and Response. The Committee considered a list of devices that would be needed in the event of a chemical or biological attack.

The Program Operations Staff (POS) is also involved in bioterrorism preparedness and response by providing support to the ODE Divisions that are directly involved. In particular, the IDE staff has been very helpful by providing guidance on difficult regulatory issues, such as the NPRM discussed above.

 Study Determination Inquiries

Every year, the Office of Device Evaluation (ODE) handles 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 02 ODE received 76 inquires. Of the 76 inquires, there were 19 SR determinations, 33 NSR determinations, 19 exempt determinations, and 5 inquires still under review.

 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 the Chief Mediator and Ombudsman. These formal submissions contain the material describing the requester's product and/or products and their proposal regarding which Center should be give lead designation over their product and whose authorities (Biological, Device or Drug) should apply.

In FY 2002 CDRH participated in the review of 33 out of 37 (four were assigned wholly to CDER and CBER only) RFD's received by the FDA's Ombudsman's Office, in addition to completing the review of 5 RFDs received in FY 2000. The reviews of the 33 new requests were assigned to the ODE Divisions as follows: DGRND was assigned 9 (nine); DAGID was assigned 8 (eight) to review and shared in the review of 2 others; DCD was assigned to review 5 (five); DRARD was assigned 4 (four) and shared in the review of one other; DOED was assigned 3 (three); and, DCLD was assigned 1 (one) and shared review in an one other. One RFD was not assigned to a division, rather it was handled by the Jurisdiction Coordinator.

Of the 33 FY 2002 RFDs in which CDRH was involved: CDRH was assigned the lead center in 13 (thirteen) of those requests; CDER was assigned lead center in 9 (nine); CBER was designated lead in 4 (four) RFDs; 2 (two) were withdrawn before their review could be completed; and, 5 (five) were not due for completion until FY2003.

 CLIA Activities

Congress passed the Clinical Laboratory Improvement Amendments in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The categorization of commercially marketed in vitro diagnostic tests under CLIA has been the responsibility of the FDA since February 2000. DCLD performs the CLIA complexity categorization that includes the assignment of these test systems to one of three CLIA regulatory categories (high, moderate and waived) based on their potential risk to public health. During FY02 DCLD performed categorizations on 231 High, 1564 Moderate, and 315 Waived tests. FDA, CDC, and CMS are working together to publish a final rule on CLIA standards. More information on the CLIA program can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ IVDRegulatoryAssistance/ucm124105.html.

 Advisory Panel Activities

The Office of Device Evaluation’s Medical Devices Advisory Committee (MDAC) with its 18 panels provides clinical and scientific advice to FDA in several areas of activity fundamental to the regulation of medical devices. The most significant of these areas of activity are: (1) classification and reclassification of medical devices into one of three classes based on risk, (2) review and make recommendations on premarket submissions such as Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Premarket Notification submissions (510ks), (3) provide advice on guidance documents which convey to industry and the agency staff FDA’s expectations for studies and data for premarket review, and (4) provide input on issues or problems concerning the safety and effectiveness of medical devices.

In FY 02, ODE held 14 panel meetings. The panels reviewed and made recommendations on: 11 PMAs, 2 PMA supplements, 1 510(k), 1 reclassification petition, and 4 general issues. The panels reviewed significant medical device breakthrough technologies such as a spinal fusion cage with a growth factor soaked in a collagen sponge intended for use to treat lumbar degenerative disease, an implantable pacemaker/defibrillator used for treatment of both congestive heart failure and life threatening dysrhythmias, and a contact lens for corneal refractive therapy with overnight wear for the temporary reduction of myopia.

CDRH conducts training sessions for new panel members and consultants prior to their participation on a panel. In FY02, there were 13 training sessions for new members.

Announcements of panel meetings are publicized in several ways: voice information via the FDA Advisory Committee Information Line (1-800-741-8138), printed information in the Federal Register, and on the Internet (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/default.htm). This website also includes summaries of the most recent advisory panel meetings.

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

The MDAC advisory panels are key to ensuring that the agency has access to the nation’s most esteemed medical 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 medical device review program.

 ODE Integrity Program

During this fiscal year, ODE considered about 47 cases concerning the integrity of data submitted to the agency in premarket applications. Under the Application Integrity Program (AIP), two firms were placed on the AIP list and AIP restrictions applied against this firm. An Integrity Hold was placed on one firm’s application and removed from another firm’s application during the fiscal year.

ODE handled 25 instances related to questions arising under the standards of conduct for employees. During FY 02, as in years past, the ODE 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
http://www.usoge.gov/ethics_docs/publications/reference_publications/rfsoc_02.pdf.