The FDA (U.S. Food and Drug Administration) is an agency within the U.S. Department of Health and Human Services (HHS) that oversees the manufacturing and distribution of food, pharmaceuticals, medical devices, tobacco and other consumer products and veterinary medicine.
The FDA also oversees the development of biological products such as vaccines, products that treat allergies and cosmetics. FDA regulations govern medical devices, food safety, dietary supplements and cosmetics with the intent of ensuring those products are accurately labeled and safe to use. The FDA issues recalls for food and other products that are potentially unsafe.
Guides to the FDA approval processes and guidelines for medical and radiological devices are available on the agency's website.
History of the FDA
The FDA defines itself as the country's oldest consumer protection agency. It traces its origins to the U.S. Patent and Trademark Office in 1848 and the creation of the U.S. Department of Agriculture in 1862, which carried on the Patent Office's duties during chemical analyses of agricultural products. The FDA's regulatory functions started with the 1906 passing of the Pure Food and Drug Act.
What the FDA regulates
As it relates to the healthcare industry, one of the FDA's main goals is to protect the American public from radiation produced by electronic medical and consumer devices. All products that give off radiation, such as lasers, X-ray systems and ultrasound equipment, must be preapproved by the FDA's Center for Devices and Radiological Health (CDRH) before they can go to market. After the CDRH recognizes that a product was safely manufactured, state agencies supervise the use of that product within their jurisdictions.
The FDA sorts medical devices into three categories according to the stringency of regulation and risk associated with it. Class I is comprised of low-risk devices, such as many health and wellness wearables, manual wheelchairs and toothbrushes. The FDA approval process is not applied to 95% of Class I products.
The CDRH has labeled wearable wellness devices used for general health purposes -- such as losing weight, maintaining physical fitness and measuring sleep -- that present minimal risk to users' safety as Class I. The CDRH does not plan to impose sanctions on the misuse of any of these products, as they are not intended to treat a specific condition or disease.
Wellness devices include products primarily for fitness tracking, such as Fitbit and Samsung Gear. The Pebble Smartwatch, Apple Watch, Withings Activité and other smartwatches also fall under the wellness device category. The CDRH has also said it generally does not regulate mobile health, or mHealth, apps, but has reserved the discretion to do so if it deems it necessary.
Class II devices are defined as moderate- to high-risk items. In healthcare, these devices include cardiac output monitors, wearable body monitoring devices that quantify physical movement for medical purposes, anesthesia kits and infusion pumps that have increasingly become connected to hospital computer networks. FDA regulations require most Class II devices to go through a 510(k) premarket notification approval process in which the manufacturer demonstrates how the device is at least as safe and effective as a legally marketed device.
Manufacturers of Class III devices are required to submit a premarket approval application for the device. Devices in this class are products or medical equipment that preserve or improve patients' health. Only 10% of all medical devices fall into this category, including replacement heart valves, breast implants and pacemakers.
The FDA and health IT
The FDA has often weighed in on health IT matters, such as wearable wellness devices, by publishing nonbinding, but influential, guidance. For example, a February 2016 report, "Postmarked Management of Cybersecurity in Medical Devices," urges manufacturers to improve the cybersecurity of their devices and recommends that vendors work with a voluntary cybersecurity framework developed by the National Institute for Standards and Technology (NIST).
Thus far, the FDA has mostly stayed away from regulating the use of health IT products. In 2014, two years after downgrading medical device data systems from Class III to Class I, the agency released a draft report that freed mobile health application vendors from registering their apps with the FDA and reporting product malfunctions. The FDA proposed this regulation reduction in the hopes that vendors would have more time to focus on improving the interoperability of their products with different healthcare systems, such as electronic health records or clinical decision support systems.