Streamlining the Regulatory Path to Market for Low-Risk Med Devices

Determining Whether the Product Is a Device In Chapter 9, Section 201 of the Federal Drug & Cosmetic (FD&C) Act, a device is defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is— RECOGNIZED IN THE OFFICIAL NATIONAL FORMULARY, the United States Pharmacopeia, or any supplement to them INTENDED FOR USE IN THE DIAGNOSIS of disease or other conditions or in the cure, INTRODUCTION Medical devices are life-enhancing and lifesustaining products that encompass a vast spectrum of products, from bandages to pacemakers. USbased companies dominate the roughly $350 billion global medical device industry, and, as a result, America exports more medical devices than it imports.1 The U.S. Food and Drug Administration (FDA) is responsible for regulating firms that design, manufacture, repackage, relabel, or import medical devices sold in the United States. The FDA categorizes medical devices into three classes based on the level of regulatory control needed to provide reasonable assurance of safety and effectiveness. Because Class III devices pose a potential for serious risk to humans, all Class III devices must be evaluated in clinical trials before receiving Premarket Approval from the FDA. As with medical drugs, clinical trials for medical devices take a lot of time and cost a lot of money. In general, the clearance process for Class I and II devices is simpler and commonly does not require novel clinical trial data. Class I and II devices rely mostly on safety and performance data in accordance with quality regulations and consensus standards. Especially when clinical trials are not required, developing Class I and II devices is very feasible for small companies without large capital reserves. Once a device receives clearance for sale in the United States, expanding into global markets can be relatively simple because the FDA is a globally 2 mitigation, treatment, or prevention of disease in man or other animals INTENDED TO AFFECT THE STRUCTURE or any function of the body of man or other accepted health authority that has partnerships with other major markets. Most of the documentation and testing required for the FDA is accepted in the European Union, Canada, and some countries in Latin America as well as the Asia-Pacific region. Although the process of FDA clearance for Class I and II medical devices is simpler than for medical drugs and Class III devices, the various submission standards are not always obvious or intuitive, and failure to properly navigate them can lead to wasted resources at best and federal prosecution at worst. Following is a breakdown of important steps in receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process. ‘‘ US-based companies dominate the roughly $350 billion global medical device industry, and, as a result, America exports more medical devices than it imports.1 animals and does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and is not dependent upon being metabolized for the achievement of its primary intended purposes.2 Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices. However, the results achieved by medical devices may be assisted by these means. Per the FD&C Act, companies cannot sell, transport, distribute, or export Class II or III devices without FDA clearance or approval. In contrast, most Class I devices are exempt from FDA review and can be commercialized after the manufacturer or distributor registers their establishment with the FDA.3 Failure to register as a device establishment or to list a medical device with the FDA can result in advisory actions (warning letters), administrative actions (administrative detention, recalls, and civil penalties), or judicial actions (seizures, injunctions, and criminal prosecutions).4 Figure 1. Important Steps in Receiving FDA Clearance and Strategies for Streamlining the Process STEP 3 STEP 2 Confirming the Classification Understanding the Classes and Corresponding Regulatory Controls STEP 5 Defining the Medical Device STEP 1 Determining Whether the Product is a Device ü STEP 4 Identifying Predicate Devices Already Cleared for Sale STEP 6 Developing a Regulatory and Strategic Pathway

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