The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. It replaced the earlier Pure Food and Drug Act of 1906.

Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires those Medical Device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device in the United States of America. This is also known as Premarket Notification (PMA) which allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

Any device that reaches US market via a 510(k) notification must be "substantially equivalent" to a device legally marketed in United States. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate”. If a device being submitted is significantly different, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA. This does not always happen.

We are consultants helping organization to comply with 21 CFR Part 820 (US FDA GMP for Medical Device manufactures) of US federal law and complete 510(k) applications successfully and fast.

More information about our services, fee, and other related information can be obtained by further reading our web site.

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