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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

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

Thank You