FDA Quality System Requirements (Good Manufacturing Procedures)
Once the FDA has approved or allowed the use of a medical device in the US market, they have established a comprehensive set of standards that manufacturers must adhere to. These requirements or procedures are mandatory and enforceable by the FDA. This is an ever evolving set of instructions that all manufacturers must understand, implement and live by. The FDA can audit any manufacturer at any time and determine how well these rules are being followed. The FDA has the right to require corrective action on the part of a device manufacturer to ensure that these standards are adhered to. The FDA can enforce recalls, effect changes and in extreme cases demand the seizure of product or revoke the manufacturer's ability to sell. IHT is constantly striving to maintain, expand and perfect these on-going standards.