Todd J. Banks1 and Gurpreet S. Ahluwalia2
1Regulatory Affairs Manager, The Procter & Gamble Company, Cincinnati, OH 45241, USA 2The Gillette Company, a wholly owned subsidiary of The P&G Company,
Needham, MA, USA
Before a medical device can be introduced into commerce, the manufacturer or the distributor must receive clearance or approval from the Food & Drug Administration (FDA). The FDA provides a clear definition for determining if the device is a ‘medical device’, which is similar in principle to determining if a chemical agent is a drug or a cosmetic. Generally, if the device is intended for the treatment, prevention, or diagnosis of a disease, or achieves its intended purpose by affecting the structure or any function of the body, it falls under the medical device definition. Medical devices are further classified by the FDA into three classes (I-III) based on their intended use, which also determines the risks and the level of controls needed to ensure safe and effective use of the device. Depending on the device classification, the clearance for marketing is obtained either via premarket notification—510(k), or a premarket approval process (PMA). A simpler and faster 510(k) process is reserved for those devices that can be demonstrated to be substantially equivalent to a legally marketed Class-I or a Class-II medical device. The PMA process is generally followed for the Class-III medical devices.
In the United States, laser and light-based systems used in dermatology, including those indicated for cosmetic application, are regulated as medical devices. The rapid rate of technological advancements and market introduction of these devices has been made possible by the regulatory pathway of 510(k) notification. The process is based on demonstrating to the FDA that the new or modified device is substantially equivalent to a marketed device (predicate) in terms of its intended use, indication for use, and the technology specifications. Depending on the similarities and differences between the predicate and the new device, the FDA may require performance data as a further proof of efficacy and a reasonable assurance of safety. A clinical test is required when the bench tests and in-vitro data cannot adequately demonstrate the
equivalence to a predicate device. However, before a clinical test can begin an Investigational Device Exemption (IDE), an application must be submitted to evaluating a developmental medical device the FDA which should include an IRB approval on the clinical protocol.
This chapter provides a historical overview of the evolution of FDA medical device regulations and the regulatory approval pathways FDA permits based on the classification of the device. The 510(k) process as it relates to the laser and light-based devices is described in greater detail. In addition, the contents and format of an IDE, a clinical protocol and a 510(k) application are presented.