Assignment and Request for Agency Component Designation for Premarket Applications (21CFR Part 3.1-3.10)
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The main purpose of 21 CFR Part 3 is to support the efficiency of agency management and operations by providing guidelines for determining the agency component that will have primary jurisdiction for any drug, device, or biological product or providing the guidelines for the agency component determination where such jurisdiction is unclear. Out of 10 sections of the 21CFR Part 3 (Product Jurisdiction), the blog has the main emphasis on Sec 3.5 and 3.7 that relates to the guidance documents for agency designations as well as the requirements for request of agency designation in case the designation is unclear as per the guidance.
As per Sec 3.5, The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have developed guidance documents clarifying product jurisdictional issues. The guidance documents entitled "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;" "Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research;" "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research." are available in the Division of Dockets Management (HFA-305), Food and Drug Administration. These guidance documents describe the responsibility for categories of products or specific products.
The sponsor of a premarket application filing for a combination or other product covered by these guidance documents may contact the designated agency component identified in the intercenter agreement before submitting an application of premarket review or to confirm coverage and to discuss the application process.
For a combination product not covered by the guidance document or for a product where the agency component with primary jurisdiction is unclear or in dispute, the sponsor of an application for premarket review should follow the procedures described in Sec 3.7 to request a designation of the agency component with primary jurisdiction before submitting the premarket application.
For filing the designation request, an original and two copies of the request for designation are required with a page limit of 15 pages, including attachments, and must have the detailed identity of the sponsor and the product. If any component of the product has already received the premarket approval the Identification of such a component must be included in the designation request letter.
In the request for designation, the sponsor's are encouraged to provide with the recommendation as to which agency should have primary jurisdiction based on the mode of action that provides the most important therapeutic action of the combination product. If the sponsor is unable to determine, then the recommendation must be based on the assignment algorithm provided in section 3.4(b).
For further details about the Product Jurisdiction follow the link. Rest will follow….
The main purpose of 21 CFR Part 3 is to support the efficiency of agency management and operations by providing guidelines for determining the agency component that will have primary jurisdiction for any drug, device, or biological product or providing the guidelines for the agency component determination where such jurisdiction is unclear. Out of 10 sections of the 21CFR Part 3 (Product Jurisdiction), the blog has the main emphasis on Sec 3.5 and 3.7 that relates to the guidance documents for agency designations as well as the requirements for request of agency designation in case the designation is unclear as per the guidance.
As per Sec 3.5, The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have developed guidance documents clarifying product jurisdictional issues. The guidance documents entitled "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;" "Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research;" "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research." are available in the Division of Dockets Management (HFA-305), Food and Drug Administration. These guidance documents describe the responsibility for categories of products or specific products.
The sponsor of a premarket application filing for a combination or other product covered by these guidance documents may contact the designated agency component identified in the intercenter agreement before submitting an application of premarket review or to confirm coverage and to discuss the application process.
For a combination product not covered by the guidance document or for a product where the agency component with primary jurisdiction is unclear or in dispute, the sponsor of an application for premarket review should follow the procedures described in Sec 3.7 to request a designation of the agency component with primary jurisdiction before submitting the premarket application.
For filing the designation request, an original and two copies of the request for designation are required with a page limit of 15 pages, including attachments, and must have the detailed identity of the sponsor and the product. If any component of the product has already received the premarket approval the Identification of such a component must be included in the designation request letter.
In the request for designation, the sponsor's are encouraged to provide with the recommendation as to which agency should have primary jurisdiction based on the mode of action that provides the most important therapeutic action of the combination product. If the sponsor is unable to determine, then the recommendation must be based on the assignment algorithm provided in section 3.4(b).
For further details about the Product Jurisdiction follow the link. Rest will follow….
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