We’ve had recent questions regarding the Food and Drug Administration (FDA) approval process for new medical devices, so we felt it was time to revisit the topic. We realize that as both physicians and providers, the pressure can be great when both patients and clients come to you wanting information about the latest device reported on the news or Internet. The following is designed to give you an overview of the process to better inform those inevitable discussions.
The level of regulation for medical devices is governed by the class to which a particular device is assigned by the FDA. Device classification is risk based, meaning that the user risk is a major factor in determining the class to which it is assigned. In addition, the device classification depends on the intended use (the exact use for which the product is intended) of the device as well as the indications for use (the precise reasons and situations as to why the product would be used).
Devices are assigned to the following classes:
- Class I includes devices with the lowest risk. Class I devices must meet “General Control” requirements that include:
- Suitability for intended use
- Manufacture under a quality assurance program
- Adequate packaging and labeling
- Registration of the manufacturing site/establishment
- Device listing
- Good Manufacturing Practices (GMP)
- Class II includes devices of moderate risk. Devices in this class are not implantable. In addition to the General Control requirements from class I, class II devices must also meet “Performance Standards” (http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RegulatedProducts/default.htm).
- Class III includes devices with the greatest risk. Devices in this class must meet all of the requirements in classes I and II. In addition, class III devices cannot be marketed until they receive Premarket Approval (PMA) or until a Premarket Notification (PMN) 510(k) submission is judged by the FDA to demonstrate “substantial equivalence” to a legally marketed device.
So what is the difference between a PMA and a 510(k)? The approval process for PMA devices is similar to that for prescription drugs, meaning that the FDA requires the manufacturers of PMA devices to prove efficacy and safety by providing data showing the device’s performance in humans. The FDA also has the authority to regulate the promotion of PMA devices. As with prescription products, the manufacturers of PMA devices cannot make false or misleading claims about their devices; they also must include warnings and contraindications in any advertisement.
“The manufacturers of 510(k) devices must demonstrate only that these devices have the same intended use and are substantially equivalent to similar legally marketed devices.”
The regulation of 510(k) devices is quite different. The FDA does not require human trials to prove efficacy and safety since these devices are considered to be at least as safe and effective as similar devices already on the market. Instead, the manufacturers of 510(k) devices must demonstrate only that these devices have the same intended use and are substantially equivalent to similar legally marketed devices. In 2015, the FDA approved 3,006 510(k) devices compared with 47 PMA devices (Source: www.fda.gov).
That’s an alarming statistic, particularly when you consider that the Archives of Internal Medicine showed higher recall rates for devices cleared through the 510(k) process compared with those approved via the PMA process. From 2005 through 2009, a total of 113 devices were recalled. Of these, more than 70% were cleared through the 510(k) process. Another 7% of these devices were exempt from FDA regulation.
Hayes Prognosis follows health technologies (see our blog, “Peanut Allergy Drug Therapies Make National Headlines”) as they move through the regulatory process. In addition, our News Service keeps you abreast of the latest FDA developments. Our Health Technology Briefs provide health technology assessments for devices newer-to-market for which there is a limited body of peer-reviewed, published evidence.
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