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Over the years there have been ad hoc agreements between the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) concerning the status of products, that is, whether they are regulated as devices or drugs. It has become clear that the two Centers need to reach agreement on generic categories of products and to put these agreements in a form that would be available as a guide to the industry on the proper Center to contact for products subject to the agreement. This document is the agreement which identifies those products subject to regulation as devices and those subject to regulation as drugs and supersedes all previous agreements and decisions except for the Transitional Device Notice published in the Federal Register (42 CFR 63472) in 1977. It also outlines the working relationship between CDER and CDRH for the categories of products subject to this agreement.
Inquiries regarding this Agreement should be addressed to:
Richard Chastonay
Center for Drug Evaluation and Research (HFD�0)
Food and Drug Administration
7520 Standish Place (MPN)
Rockville, Maryland 20850
(301) 295�63
or
Leighton W. Hansel
Center for Devices and Radiological Health (HFZ�0)
Food and Drug Administration
1390 Piccard Drive
Rockville, Maryland 20850
(301) 427�11
I. EFFECTIVE DATE.
This document takes effect October 31, 1991.
II. GENERAL DESCRIPTION.
The Center for Devices and Radiological Health is designated the lead center in FDA for regulating medical devices and radiation璻elated medical devices to ensure their safety and effectiveness. CDRH will generally use the device authorities of the Federal Food, Drug, and Cosmetic Act (Acts) and the Electronic Product Radiation Control requirements of the Act, as appropriate, for devices regulated in that Center. The Center for Drug Evaluation and Research is designated the lead Center in FDA for regulating drugs to ensure their safety and effectiveness and will generally use authorities under the drug provisions of the Act.
Section VII provides details concerning the products covered by this agreement and Section VIII describes the criteria to be applied in making drug/device determinations. Under the provisions of the Safe Medical Devices Act of 1990 and regulations promulgated to implement the combination product provisions of that Act, CDER and CDRH each may use both the drug and device provisions of the Federal Food, Drug, and Cosmetic Act as appropriate to regulate a combination product. (See 21 CFR Part 3).
III. DEVICE PROGRAMS THAT CDRH WILL ADMINISTER.
The Center for Devices and Radiological Health is designated the Center for major policy development and for the promulgation and interpretation of procedural regulations for medical devices under the Act. The Center for Devices and Radiological Health regulates all medical devices inclusive of radiation璻elated devices, that are not assigned categorically or specifically to CDER. In addition, CDRH will independently administer the following activities (references to "Sections" are the provisions of the Act):
IV. DEVICE PROGRAMS THAT CDER AND CBER EACH WILL ADMINISTER.
Both CDER and CDRH will administer and, as appropriate, enforce the following activities for medical devices assigned to their respective Centers (References to "Sections" are the provisions of the Act):
V. COORDINATION.
The Centers will coordinate their activities in order to assure that manufacturers do not have to independently secure authorization to market their product from oath Centers unless this requirement is specified in the Section VII.
VI. SUBMISSIONS.
Submissions should be made to the appropriate Center, as specified herein, at the addresses provided below:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room (Room #2-14)
12420 Parklawn Drive
Rockville, Maryland 20852
or
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center (HFZ�1)
1390 Piccard Drive
Rockville, Maryland 20850
For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the Centers.
VII. CENTER JURISDICTION.
The following subsections provide details concerning status, market approval authority, special label/regulatory considerations, investigational options, and inter璫enter consultations for the categories of products specified. Section VIII provides the general criteria that CDRH and CDER will apply in reaching decisions as to which Center will regulate a product.
A.1(a) Device with primary purpose of delivering or aiding in the delivery of a drug that is distributed without a drug (i.e., unfilled).
EXAMPLES
Status: Device and drug, as separate entities.
Market Approval Authority: CDRH and CDER, respectively, unless the intended use of the two products, through labeling, creates a combination product.
Special Label/Regulatory Considerations: The following specifics procedures will apply depending on the status of the drug delivery device and drugs that will be delivered with the device:
Investigation Options: IDE or IND, as appropriate.
Inter瑿enter Consultation: CDER, when lead Center, will consult with CDRH if CDER determines that a specific device is required as part of the NDA process. CDRH as lead center will consult with CDER if the device is intended for use with a marketed drug and the device creates a significant change in the intended use, mode of delivery (e.g., topical, I.V.), or dose/schedule of the drug.
(b) Device with primary purpose of delivering or aiding in the delivery of a drug and distributed containing a drug (i.e., "pre璮illed delivery system")
EXAMPLES
Status: Combination Product
Market Approval Authority: CDER using drug authorities and device authorities, as necessary.
Special Label/Regulatory Considerations: None
Investigation Options: IND
Inter瑿enter Consultations: Optional
2. Device incorporating a drug component with the combination product having the primary intended purpose of fulfilling a device function.
EXAMPLES
Status: Combination Product
Market Approval Authority: CDRH using device authorities.
Special Label/Regulatory Considerations: These products have a drug component that is present to augment the safety and/or efficacy of the device.
Investigation Options: IDE
Inter瑿enter Consultation: Required if a drug or the chemical form of the drug has not been legally marketed in the United States as a human drug for the intended effect.
3. Drug incorporating a device component with the combination product having the primary intended purpose of fulfilling a drug function.
EXAMPLES
Status: Combination Product
Market Approval Authority: CDER using drug authorities and, as necessary, device authorities.
Special Label/Regulatory Considerations: Marketing of such a device requires a submission of an NDA with safety and efficacy data on the drug component or it meets monograph specifications as generally recognized as safe (GRAS) and generally recognized as effective (GRAE). Drug requirements, e.g., CGMPs, registration and listing, experience reporting apply to products.
Investigation Options: IND
Inter瑿enter Consultation: Optional
4(a)Device used in the production of a drug either to deliver directly to a patient or for use in the producing medical facility (excluding use in a registered drug manufacturing facility).
EXAMPLES
Status: Device
Market Approval Authority: CDER, applying both drug and device authorities
Special Label/Regulatory Consideration: May also require an NDA if the drug produced is a new drug. Device requirements, e.g., CGMPs, registration and listing, experience reporting will apply to products.
Investigation Options: IDA: or NDA, as appropriate.
Inter瑿enter Consultation: Optional
4(b) Drug/Device combination product intended to process a drug into a finished package form.
EXAMPLES
Status: Combination product
Market Approval Authority: CDER, applying both drug a and device authorities.
Special Label/Regulatory Considerations: Respective drug and device requirements, e.g., CGMPs, registration and listing, experience reporting will apply.
Investigation Options: IDE or NDA, as appropriate.
Inter瑿enter Consultation: Optional, but will be routinely obtained.
B. Device used concomitantly with a drug to directly activate or to augment drug effectiveness.
EXAMPLES
Status: Device and drug, as separate entities
Market Approval Authority: CDRH and CDER, respectively
Special Label/Regulatory Considerations: The device and drug labeling must be mutually conforming with respect to indications, general mode of delivery (e.g., topical, I.V.), and drug dosage/schedule equivalence. A lead center will be designated to be the contact point with the manufacturer. If a drug has been developed and approved for another use and the development and studying of device technology predominates, then CDER would have lead. If a device has been developed and marketed for another use and the development and studying of drug action predominates, then CDER would have lead. If neither the drug nor the device is on the market, the lead center will be determined on a case璪y璫ase basis. If the labeling of the drug and device create a combination product, as defined in the combination product regulations, then the designation, of the lead Center for both applications will be based upon a determination of the product's primary mode of action.
Investigation Options: lDE or IND, as appropriate.
Inter瑿enter Consultations: Required.
2. Device kits labeled for use with drugs that includes both device(s) and drug(s) as separate entities in one package with the overall primary intended purpose of the kit fulfilling a device function.
EXAMPLES
Status: Combination Product
Market Approval Authority: CDRH, using device authorities is responsible for the kit if the manufacturer is repackaging a marketed drug. Responsibility for overall packaging resides with CDRH. CDER will be consulted as necessary on the use of drug authorities for the repackaged drug component.
Special Label/Regulatory Considerations: Device requirements, e.g., CGMPs, registration and listing, experience reporting apply to kits. Device manufacturers must assure that manufacturing steps do not adversely affect drug components of the kit.
If the manufacturing steps do affect the marketed drug (e.g., the kit is sterilized by irradiation), an ANDA or NDA would also be required with CDRH as lead center.
Investigation Options: IDA or IND, as appropriate.
Inter瑿enter Consultation: Optional if ANDA or NDA not required.
C. Liquids, gases, or solids intended for use as devices (e.g., implanted, or components, parts, or accessories to devices).
EXAMPLES
Status: Device
Market Approval Authority: CDRH
Special Label/Regulatory Considerations: None
Investigation Options: IDE
Inter瑿enter Consultation: Required if the device has direct contact with the body and the drug or the chemical form of the drug has not been legally marketed as a human drug.
D. Products regulated as drugs.
EXAMPLES
Status: Drug
Market Approval Authority: CDER
Special Label/Regulatory Considerations: None
Investigation Options: IND
Inter瑿enter Consultations: Optional
E. Ad Hoc Jurisdictional Decisions.
motility marker constructed of radiopaque plastic | CDRH | |
brachytherapy capsules, needles, etc., that are radioactive and may be removed from the body after radiation therapy has been administered | CDRH | |
skin markers | CDRH |
Status: Device or drug
Market approval authority: CDRH or CDER as indicated.
Special label/regulatory considerations: None
Investigational options: IDE or IND, as appropriate
Inter-center consultation: Required to assure agreement on drug/device status.
VIII. GENERAL CRITERIA AFFECTING DRUG/DEVICE DETERMINATIONS.
The following represent the general criteria that will apply in making device/drug determinations:
A. Device Criteria:
B. Drug Criteria:
IX. INTERCENTER JURISDICTIONAL COMMITTEE.
An intercenter jurisdictional committee is now formed. The committee members will meet on an ad hoc basis, will discuss all jurisdictional questions, and will be expected to handle the majority of requests for jurisdictional assignments. Where this committee cannot agree upon the jurisdictional assignment, or where the sponsor requests review of assignment at the Agency level, the product jurisdiction procedures will be used.
Signed:
Carl C. Peck, M.D., Director
Center for Drug Evaluation and Research
Dated: 10/31/91
Signed:
James S. Benson, Director
Center for Devices and Radiological Health
Dated: 10/31/91
Concur:
Signed:
David A. Kessler, M.D.
Commissioner of Food and Drugs