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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
sulfate contrast agents, as drugs allowed us to regulate them consistently under the same authority in the Center for Drug Evaluation and Research CDER
and was intended to be consistent with a previous court decision, Bracco Diagnostics, Inc. v. Shalala, 963 F.
Supp. 20 D.D.C. 1997.
In the Genus litigation, both the District Court and the Court of Appeals, as a matter of statutory interpretation, disagreed with FDAs view that the Agency had discretion to regulate products meeting the device definition as drugs. The Court of Appeals determined that FDA cannot classify as a drug any product that meets the definition of device, stating excepting combination products, . . . devices must be regulated as devices and drugsif they do not also satisfy the device definitionmust be regulated as drugs.
II. Discussion
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A. Product Classification Decisions Going Forward FDA has issued guidance on its approach to classification decisions for drugs and devices. See FDAs guidance for industry and FDA staff Classification of Products as Drugs and Devices & Additional Product Classification Issues September 2017, available at https www.fda.gov/media/
80384/download. That guidance reviews the definitions of the terms drug and device found in section 201g and h of the FD&C Act, respectively. Both definitions include similar intended use clauses, with drugs including articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals . . . and articles other than food intended to affect the structure or any function of the body of man or other animals and devices including certain articles intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . . or articles intended to affect the structure or any function of the body of man or other animals. A
medical product meets the device definition if it 1 is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, and 2 does not achieve its primary intended purposes through chemical action within or on the body, and 3 is not dependent upon being metabolized for the achievement of its primary intended purposes.

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Going forward, in accordance with Genus, FDA intends to regulate products that meet both the device and drug definition as devices, except where the statute indicates that Congress intended a different classification, and we further intend to bring previously classified products into line with the Genus decision. Accordingly, FDA will examine product classifications, paying particular attention to those products that have been regulated as drugs even though they may satisfy the device definition. We expect the determining factor in many cases to be whether the product achieves its primary intended purposes through chemical action within or on the body or is dependent upon being metabolized for the achievement of its primary intended purposes. Historically, FDA has not always examined these factors in determining how to regulate certain types of medical productse.g., imaging agents, which are discussed further belowbecause the Agency believed it had discretion to regulate such products as drugs even if they met the device definition. In determining product classification in the future, FDA will consider these factors. FDA will also examine whether other statutory provisionsbeyond the drug and device definitionsindicate Congress intended a type of product to be regulated under either the drug or device authorities.
B. Imaging Agents Some medical imaging techniques can depend solely on an imaging device to produce and display images. These techniques include ultrasound, computerized tomography CT, magnetic resonance imaging MRI, and traditional radiology. However, imaging agents are sometimes used in conjunction with these imaging devices to provide image enhancement. For example, with CT and MRI, the addition of an imaging agent may improve the visualization of tissues, organs, and physiologic processes in part by increasing the relative difference of imaging signal intensities in adjacent regions of the body. In other cases, such as radiopharmaceutical imaging, including single photon emission computerized tomography and positron emission computerized tomography, the device alone cannot produce a usable image, and it is necessary to administer an imaging agent to the patient before using the imaging device.
For the past two decades, FDA has generally regulated the imaging agents used in these procedures as drugs without consideration of whether they appear to achieve their primary intended purposes through chemical
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action within or on the body or whether they are dependent upon metabolization for the achievement of their primary intended purposes. Following the Genus decision, we intend to reexamine whether individual imaging agents meet the device definition, including whether they achieve their primary intended purposes through chemical action within or on the body or are dependent upon being metabolized for the achievement of their primary intended purposes. As noted above, we intend to reexamine other product categories as well, as appropriate.
C. Product Transition Issues Implementation of the Genus decision will require FDA to transition some approved products from drug status to device status. FDA will aim to effect necessary product transitions in a way that does not disrupt the supply of these important medical products or place undue burden on manufacturers or on the healthcare delivery system. Some operational issues raised by product transitions necessitated by Genus are discussed briefly below.
1. Categories of Products Implicated by Genus Stakeholders are invited to submit comments regarding categories of products currently regulated as drugs that may be required to transition to device status under Genus. Comments are also welcome regarding statutory provisions other than the drug and device definitions that may indicate Congressional intention regarding the appropriate regulatory pathway i.e., drug or device for certain types of products.
2. Transition Process FDA currently anticipates that it will publish in a future Federal Register notice a list of approved drug products that we tentatively determine should transition to device status under Genus.
Stakeholders would then have an opportunity to comment on those tentative determinations before classification determinations are made.
3. Transition Timing We recognize that there are differences between the drug regulatory requirements and the device regulatory requirements and that sponsors of transitioning marketed products will need time to transition from compliance with one to the other. For example, sponsors of transitioning products may need to update labeling, bring facilities into compliance with quality system regulations, prepare for device inspections, and come into compliance
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