A premarket submission made to the FDA demonstrating that the device is at least as safe and effective, Substantially Equivalent (SE), as a legally marketed device that is not subject to PMA. It is a key pathway that any medical device manufacturer planning to market in the U.S. must understand. Predicate Device Predicate devices are…
Manufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get 510k?” is one of the most frequent inquiries that businesses ask. However, the answer would have depended on various factors, but learning the process will help you skip unnecessarily long waits and…
If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application. If submitted too early, it can add to delays, more costs, or even recalls; submitted too late, it cannot be included in subsequent batches. At…
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.