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US FDA is a highly organized Regulatory Agency with various divisions and demarcated Regulatory responsibilities. The CDER, CBER, and CDRH are the centers that oversee the regulations of Drugs, Biologics, and Medical Devices. The products which are a combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, a device, and a biological product are commonly called combination products, and they have a defined Regulatory purview for each of these divisions. However, despite having set such clear boundaries, certain borderline products still create confusion on which the center would be in charge of reviewing the application. The FDA’s Office of Combination Products (OCP) aids the manufacturers in identifying the applicable center and addresses any queries related to the product.
The sponsor can approach the FDA Office of Combination Products (OCP) to clarify on the classification of a product as a drug/device/biological or combination product and on which medicinal product center the application needs to be filed. The manufacturers may opt for any of the following two ways:
Sponsors can submit the Request for Designation before filing any investigational/marketing application and with all the sufficient information available for the FDA to decide on the classification or assignment. A Pre-RFD may be submitted at any point during medical product development.
The timeline for OCP’s decision on the submitted RFD and Pre-RFD is Sixty (60) calendar days.
Information to be included in the RFD and Pre-RFD is as follows:
Information |
Request for Designation |
Pre- Request for Designation |
Product Details |
Yes |
Yes |
Proposed Use/Indication of Use |
Yes |
Yes |
Manufacturing Details |
Yes |
Optional |
Supportive Data/Studies |
Yes |
Optional |
Description of How a Product Achieves its Intended Therapeutic/Diagnostic Effects |
Yes |
Yes |
Analysis of Classification, Primary Mode of Action (PMOA), if it is a Combination Product and Jurisdictional Assignment. |
Yes |
Optional |
Description of Related Products |
Yes |
Optional |
Sponsor Recommendation |
Yes |
Optional |
Page Limit |
Yes |
No |
*US FDA guidance
With expertise in handling RFD and Pre-RFD submissions, Freyr can identify and compile the information and assist in preparing and reviewing the application.
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