Medical Device GMP
The US Food and Drug Administration (FDA) requires Medical Device manufacturers in the USA and foreign manufacturers who distribute their Medical devices in the USA are compliant with a quality system regulation called Medical Device GMP (Good Manufacturing Practice). These are regulatory requirements specified in 21 CFR Part 820.
These are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices. These guidelines provide the minimum requirements that a manufacturer must meet to assure that their products are consistently high quality, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent any harm from occurring to the end-user. Additional tenets include ensuring the product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase.
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.