The Center for Devices and Radiological Health has been actively engaging both industry and clinicians to solicit their feedback on important labeling changes and safety requirements surrounding many of the up-and-coming products in the ophthalmic space (eg, devices for microinvasive glaucoma surgery, premium IOLs). Clinicians and industry members face unique challenges as they design product development programs and adapt to the FDA’s refined expectations.
The purpose of the new “Clinical Trials” column is to highlight the various aspects of the clinical trial process in the context of a changing landscape of US and international regulation. Topics will include the importance of ambulatory surgical centers, the evolution of safety endpoints, and protocol deviations. This article focuses on the product development pathways for devices in the United States.
Typically, the FDA considers anything that is not a drug or a biologic product to be a medical device. If a product’s primary intended use is achieved through chemical action or metabolism, it is usually a drug.
Medical devices are divided into three classes according to their degree of risk: the higher the class, the greater the risk and degree of regulation. Classification is also based on the device’s indications for use and will determine the type of premarketing strategy required for FDA clearance/approval.
Class I devices require the least regulatory control, because they are low risk and tend to be simpler in design than both other classes.
Most class II and III devices enter the market through one of two pathways: a 510(k) notification by demonstrating substantial equivalence to a previously cleared or legally marketed “predicate” device or a PMA by demonstrating safety and effectiveness.
Some devices, including most class I devices and some class II devices, are exempt from both the PMA and 510(k) processes, and others may achieve marketing authorization through the de novo process. To be cleared through the 510(k) process, a device must be considered to be as safe and effective as (ie, substantially equivalent to) a predicate device.
The de novo classification process is for medical devices that carry a low to moderate risk but have been labeled class III because no predicate exists.
PMA, as opposed to 510(k) clearance, is reserved for class III devices. These applications almost always involve clinical data to support claims made about the device. To conduct a clinical study with an investigational device, an investigational device exemption must be submitted. An investigational device exemption allows a product to become part of an FDA-approved clinical study, much like an investigational new drug application for drugs. Typically, one study is sufficient to support a PMA application, as opposed to pharmaceutical approvals, which generally require two confirmatory clinical trials.
From a clinical trials perspective, the biggest changes in the device space are occurring in the 510(k) process. Domestically, the Center for Devices and Radiological Health has been requesting significantly more performance data. Future articles in this column will discuss some of the best strategies for success in the ever-changing regulatory landscape.