The FDA must certify medical devices prior to market release.
The Food and Drug Administration (FDA) regulates medical devices through the Center for Devices and Radiological Health (CDRH). The Food, Drug and Cosmetic Act provides laws pertaining to the certification of medical devices. Medical devices must comply with these laws enforced by the CDRH to pass certification.
History
The Food and Drugs Act of 1906 defined the first federal controls on interstate trade of food and drugs, such as mandatory use instructions and dosage on drug labels. In 1938, the Food, Drug and Cosmetic Act passed after horrific events resulting from unregulated drugs and cosmetics, and largely replaced the 1906 Act. The new act required, among other things, the FDA certification of medical devices prior to market release.
Products Requiring Certification
All medical devices manufactured in the U.S. and intended for a consumer market require certification. The CDRH also requires certification of any product that emits radiation. The FDA defines a medical device as any machine, apparatus or implant that treats or diagnoses a disease, intends to affect the body and does not act chemically.
Types of Certification
The CDRH has two types of certification: Premarket Notification and Premarket Approval. Premarket Notification certifies Class I and II medical devices. The more stringent Premarket Approval certifies Class III devices. Some Class I and II devices do not need certification. Required certification or not, the manufacturer must register their establishment, list their device with the CDRH and follow labeling and manufacturing requirements.
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