Life Sciences

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FDA To Address Remaining Pre-Amendments Class III Devices

April 10, 2009

On April 8, the FDA issued an Order implementing recommendations made by the U.S. Government Accountability Office (GAO) in its January 2009 report to Congress regarding treatment of certain Class III medical devices. Under the Order, manufacturers of 25 types of Class III devices have 120 days to submit safety and efficacy information to the FDA so that it may evaluate the risk level for each device type. Each of these types of devices was marketed prior to 1976, and therefore fell into an exception under which the FDA has allowed clearance under the 510k process, rather than the pre market approval process required for Class III devices. The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit pre-market approval applications or will re-classify the devices into Class I or Class II.

According to a statement from Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, the FDA is “…taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency....” “New pre-market notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.”

Reclassification

If a manufacturer believes that its device should be reclassified as a Class I (general controls) or Class II (special controls) device, it may either submit a formal reclassification petition or submit the following information:

• A brief narrative identification of the device that is specific enough to distinguish a particular device from a generic type of device. This identification may include a listing of the materials, and the component parts, and a description of the intended use of the device.
• An identification of the risks to health that summarizes all adverse safety and effectiveness information that has not been submitted under section 519 of the act, particularly the most significant information. The mechanisms or procedures that will control the risk also should be described.
• A list of the general hazards associated with the device and a bibliography with copies of the referenced material.
• A statement that the manufacturer believes the device should be reclassified into Class I or class II, and a summary of reasons for recommendation, as well as a description of the special controls that the manufacturer believes would be sufficient to provide reasonable assurance of the safety and effectiveness of its device if it believes the device should be reclassified into Class II.
• A summary of valid scientific evidence on which the recommendation for reclassification is based.

Continued Class III Classification

If a manufacturer is not aware of adequate and valid scientific information that would support the reclassification of its device into Class I or Class II, or the manufacturer is aware of adequate and valid scientific information that would support leaving the device as a Class III device, it must provide the following:

• A general description of the disease or condition to be diagnosed, treated, cured, mitigated, or prevented, including a description of the patient population for which the device is intended.
• A description of the device, including an explanation of how the device functions, significant physical and performance characteristics of the device, and basic scientific concepts that form the basis for the device.
• Other device labeling, such as contraindications, warnings and precautions, and/or promotional materials.
• A summary of all adverse safety and effectiveness information and identification of the risks presented by the device as well as any mechanisms or procedures which will control the risk.
• A description of alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended.
• A summary of preclinical and clinical data, including the conclusions drawn from the studies that support the safety and effectiveness of the device, and that address the adverse effects of the device on health. The summary should include a brief description of the objective of the studies, the experimental design, how the data were collected and analyzed, and a brief description of the results of the studies, whether positive, negative, or inconclusive. The summary of the clinical study should also include a discussion of the subject inclusion and exclusion criteria, the study population, reasons for patient discontinuations, and results of statistical analyses.
• A copy of each key reference, a brief summary of the salient features of each key reference, and a brief discussion of why the reference is relevant to an evaluation of the safety and effectiveness of the device.

The April 8, 2009, Order applies to all manufacturers of the device types listed below.

If you have questions about the application of the Order to your products, please contact Bob Klepinski at (612) 492–7336 or anyone in Fredrikson & Byron’s Life Sciences Group.