Full article reprinted from "The Gray Sheet" - October 6, 2008
Find out why imaging device makers may be able to expand their labeling to incorporate new contrast agents without having to seek a change in the imaging drug's label, according to new guidance.
Full article reprinted from "The Gray Sheet" - October 6, 2008
Imaging device makers may be able to expand their labeling to incorporate new contrast agents without having to seek a change in the imaging drug's label, according to new guidance.
The 1draft document, prepared by FDA's Office of Combination Products in conjunction with FDA's device center and Center for Drug Evaluation and Research, was released Sept. 30 and posted on OCP's Web site.
The document fulfills a mandate in the 2007 Medical Device User Fee Amendments 2commitment letter to develop guidance by the end of fiscal year 2008 "to ensure timely and effective review" of imaging devices used with contrast agents or radiopharmaceuticals (3"The Gray Sheet" Feb. 18, 2008, p. 3).
Imaging devices and accompanying software evolve more rapidly than related imaging drugs, FDA acknowledges, making it difficult to modify drug and device labeling simultaneously. Therefore, in certain circumstances, it will not be required, the guidance states.
"Under the appropriate circumstances, the labeling of the imaging device can provide sufficient information about a new contrast indication using an approved imaging drug," the draft says.
For example, a single device marketing application will suffice when the product is developed or modified for use with an already approved imaging agent where the formulation, dose rate and administration method of the drug is unchanged.
Usually, the required device submission will be a pre-market approval (PMA) application, since "new indications for devices using imaging drugs are likely to raise new types of safety and effectiveness questions," the draft guidance states.
Drug applications will still be required under other scenarios. For example, a drug application alone will suffice when an imaging agent is modified for use with an approved or cleared imaging device that is not modified. If a new indication requires changes to both an imaging system and a drug, both device and drug applications are required.
In all cases, however, the safety and effectiveness of new contrast imaging indications must be established using device and drug data from clinical trials, FDA stresses. Applications should include preclinical and clinical data and, when appropriate, device software or technology validation studies.
The agency also recommends collecting data on a class of drugs rather than a specific drug; otherwise, the device's indication will be drug-specific.
Firms pursuing new contrast imaging indications should continue to consult existing guidance on pre-market submissions for ultrasound, magnetic resonance imaging, computed tomography and positron emission tomography devices, as well as imaging drug guidance documents, FDA notes.
To develop the new draft guidance, the agency consulted with imaging device makers, drug and biologics developers, and trade groups such as AdvaMed, the Medical Imaging and Technology Alliance, the Medical Imaging Contrast Agent Association and the Council on Radionuclides and Radiopharmaceuticals.
Developing An Inter-FDA Imaging Team
FDA says it expects to establish an "internal, inter-center" process for contrast imaging indications to promote consistent development and review of clinical trials.
The anticipated inter-center contrast imaging team would review clinical trial protocols, labeling, application trends and other practices to ensure consistency across the different centers. Potential topics to tackle would include risk-benefit comparisons, labeling, and scientific, technical and drug-device interaction issues.
Cross-center procedures "will promote consistency in labeling and acceptability of new indications requested," the FDA guidance explains.
OCP notes that it will provide formal and informal advice on jurisdictional, developmental, pre-market, post-market and cross-labeling issues. It will also assist in developing "focused procedures" for the imaging review divisions and branches within the agency to facilitate the work of the inter-center imaging team.
- Jessica Bylander
No one covers FDA/CDRH regulation of medical devices like "The Gray Sheet" - Sign up for your 30-day, risk-free trial today. Or call 1-800-332-2181.
