Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Registration Number: EAPE -62

Accepted - Volume 3

Registration for FDA Regulation of Combination Products
Name Mr. Alan Kirschenbaum
Organization Hyman, Phelps & McNamara, P.C.

1. Brief statement of the general nature of the views you wish to present. I. Section 204 of Medical Device User Fee and Modernization Act of 2002 shows Congressional intent to improve timeliness and efficiency of premarket reviews of combination products. II. Where a device is intended to be used with a drug, FDA currently requires the drug and device to have mutually conforming labeling. This applies not only to combination products but also other concomitant use products. Where the products are manufactured by two different companies, this requirement can unnecessarily delay, or entirely prevent, a sponsor from introducing new technological advances in an approved product. A. Example: magnetic resonance imaging (MRI) used with contrast for imaging blood flow 1. MRI devices are cleared as whole body imaging systems. MR contrast agents are currently approved for use with MRI for imaging of lesions of abnormal vascularity in the brain and spine, head and neck, and other body areas (excluding the heart). 2. MRI device manufacturers have developed post-processing analysis software that allows for improved clinical interpretation of blood flow imaging. The software requires the use of MR contrast during the MRI procedure. FDA currently will not clear these devices because the contrast agents are not approved for this specific use. 3. Under FDAs cross labeling requirement, device companies cannot bring these new advances to market unless and until a contrast manufacturer obtains approval of a new label indication for imaging of blood flow. a. If no drug company commits the resources necessary to undertake studies and submit an SNDA, the technology will never become available. b. Even if a drug company immediately decides to pursue a label change, the studies and SNDA review will take two years or more, instead of the 90 days required for 510(k) review. III. Where a device is proposed for use with a drug in a combination product or in other concomitant use, cross-labeling should not be required in certain instances. A. Criteria: 1. The two products are both approved for use together for other indications, 2. The dose and route of administration of the drug are consistent with the approved product labeling, so there is no safety issue, and 3. The mechanism of action of the drug and device together to achieve the new indication will not change. C. In these cases, device companies should be permitted to demonstrate the functionality of the device in combination or concomitant use with the drug through the device clearance process, without a change in the drug labeling.
2. The names and address of all persons who will participate in the presentation. Alan Kirschenbaum Hyman, Phelps & McNamara, P.C. 700 13th Street, N.W, Suite 1200 Washington, D.C. 20005
3. Approximate time that you request to make your presentation. 10 minutes.

EAPE -62