Text Version of PowerPoint Presentation by Alan Kirschenbaum, Esq.
Slide 1 - Statement of the Medical Imaging Contrast Agent Association
FDA Public Hearing on Combination Products
November 25, 2002
Slide 2 -
1. Scope of Combination Product Regulation
Slide 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)
Slide 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)
Slide 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
Slide 6 -
2. "Timely and Effective" Premarket Review
Slide 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.
Slide 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