Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Comment Number: EC -9

Accepted - Volume 4

Comment Record
Commentor Mr. Ronald Citron Date/Time 2002-12-02 16:23:07
Organization SFC/Solvent Free Corporation
Category Company

Comments for FDA General
Questions
1. General Comments Gentlemen: I attended the Public Hearing on November 25, 2002, and was one of the three audience members who offered further comments. My comment involved a drug delivery/unitary device - a combination product that is regulated as a drug. The delivery device, however, is a complex mechanical system with many pre-Amendment predicates that is best regulated under CDRH. Currently, CDER does not automatically call CDRH in on the approval process and a special request had to made. In any event, I propose that such devices be regulated as a 510(K) or, if necessary, as a PMA. This does NOT give marketing approval to the device, just independent approval of the device as a component of the combination product. This approval would be for the device to be used in conjunction with a drug. My reasoning is that the device component will be used for many drugs, but will have to be approved as a DRUG every time. CDRH can review the safety and effectiveness of the device component where a drug analog has been used to prove delivery capabilities. The specific drug must still be approved, but the issues will be completely drug delivery, effectiveness and stability and NOT the mechanical action along with these considerations. In this way, CDRH can have full control of the device component, leaving approval of the drug component completely to CDER. The Office of Combination Products would make the designation decision as to what office of CDRH and of CDER would have reviewing responsibilities. The Office of Combination Products would also, as specified in its charter, enable the flow of information between the two bodies.




EC -9