How do I submit a Request for Designation for a combination or non-combination product?
The Request For Designation (RFD) process is outlined in 21 CFR Part 3, and the specific information to be included in the RFD is described in detail in 21 CFR 21 CFR 3.7, both of which can be accessed at http://www.fda.gov/oc/ombudsman/part3&5.htm#request. FDA also has issued a guidance document “How to Write a Request for Designation” to provide guidance to sponsors on the kind of information FDA needs in an RFD in order to make its jurisdictional determination. The guidance is available at http://www.fda.gov/oc/combination/Guidance-How to Write an RFD.pdf. The RFD is limited to 15 pages and should include all information required by 21 CFR 3.7. On receipt of the RFD, OCP conducts a review to ensure the submission has all the information required by 21 CFR 3.7 in sufficient detail for FDA to make a determination. OCP has found that the most frequent sections of an RFD that are incomplete leading to non-filing are the following, so submitters are encouraged to pay close attention to t
The Request For Designation (RFD) process is outlined in 21 CFR Part 3, and the specific information to be included in the RFD is described in detail in 21 CFR 3.7. FDA also has issued a guidance document “How to Write a Request for Designation” to provide guidance to sponsors on the kind of information FDA needs in an RFD in order to make its jurisdictional determination. The guidance is available on the Combination Products section of the FDA website. The RFD is limited to 15 pages and should include all information required by 21 CFR 3.7. On receipt of the RFD, OCP conducts a review to ensure the submission has all the information required by 21 CFR 3.7 in sufficient detail for FDA to make a determination. OCP has found that the most frequent sections of an RFD that are incomplete leading to non-filing are the following, so submitters are encouraged to pay close attention to these sections: the intended use of the product (what the product does), its modes of action (how the product
