Statement of the Medical Imaging Contrast Agent Association

1. Statement of theMedical Imaging Contrast Agent Association FDA Public Hearing on Combination Products November 25, 2002

2. 1. Scope of Combination Product Regulation

3. Concomitant use products are not necessarily combination products • Definition of combination product: “drug, device, or biological product packaged separately that according to its . . . proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use . . . and where upon approval of the proposed product the labeling of the approved product would need to be changed . . . .” 21 CFR 3.2(e)(3)

4. Concomitant use products  combination products (cont.) • Drug proposing to be used together with approved device marketed by another company (or vice versa) to achieve intended use is not a combination product unless the other product is “individually specified” in proposed labeling. • “Definition of combination product is intended to exclude most concomitant use of drugs, devices, and biological products.” 56 Fed. Reg. 58754, 58755 (Nov. 21, 1991) (preamble)

5. Concomitant use products  combination products (cont.) • Example: contrast agents and radiopharma-ceuticals used with diagnostic imaging devices. • Drug labeling refers to type of procedure or general type of equipment, not “individually specified” device. • Imaging devices and drugs have historically been regulated independently rather than as combination products • No safety or efficacy issues due to independent regulatory paths. Therefore, no reason for change. • True medical imaging combination products are possible

6. 2. “Timely and Effective” Premarket Review

7. “Timely and Effective” Review • Section 204 of the Medical Device User Fee and Modernization Act of 2002 reflects Congress’s clear intent that combination products be reviewed in a “timely and effective” manner.

8. “Timely and Effective” Review (cont.) • Most combination medical imaging products will involve a drug. Therefore, “timely and effective premarket review” of combination products will require timely review of the safety and efficacy of the drug component. • MDUFMA § 204 makes it more important for FDA to ensure timely review by: • Reducing times to approval for new medical imaging drugs and new indications of approved drugs • Issuing a medical imaging drug guidance