HIPAA Compliance and US FDA HIPAA – The Health Insurance Portability and Accountability Act 1996. It is a set of standards introduced by the U.S. Congress consists of rules governing protected health information (PHI) including Security, Privacy, Identifiers, and Transactions and Code Sets. It promotes the protection and privacy of sensitive PHI used within the…
Premarket Approval(PMA) is one of the FDA processes of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Medical Device Labelling is the means to communicate information related to the safety and the performance of the device to the users which includes the proper identification of the device or group of devices too. It helps the end user to use the device as intended by the manufacturer.
US FDA does not issue any type of Certificates to any organization stating registration or Listing successful.