FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.
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 device”. 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 assisting 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.