All medical devices, like medications, are required to comply with the regulations of the country in which it is sold. Countries may borrow or emulate the regulatory requirements of another; therefore, we see regulatory similarities throughout the world. Most regions use a device classification to determine the process by which the device manufacturer must take to legally sell and market a device in a country. A detailed explanation is provided below for the U.S.
United States – The WellnessPro is FDA Cleared as a Class II medical device.
The U.S requires medical device manufacturers implement a quality system under 21 CFR Part 820 and submit a 510(k) Premarket Notification. The U.S. FDA 510(k) Premarket Notification submission requires medical device manufacturers to demonstrate that their device is safe and effective by providing substantial equivalence to an already legally marketed device. The U.S. classification system differs from Europe in that the manufacturer does not use a rules based system, but rather a substantial equivalent device to determine classification. If no equivalent device exists, a classification decision is made by the FDA. Device manufacturers are required to address and submit testing results, clinical data, validation, etc. as part of this 510(k) submission. If the FDA approves the device submission, the device is issued a 510(k) clearance letter and the medical device manufacturer is able to legally market and sell the device in the U.S. The U.S. FDA quality system requirements (21 CFR Part 820) were created many years before ISO 13485. Furthermore, unlike ISO 13485, there is no quality system certification program and no quality system compliance certificate is issued by the FDA. Instead, the FDA conducts random inspections to determine compliance with the quality system requirements (21 CFR Part 820).