Pre-market Submission

A pre-market submission is a formal process where a medical device manufacturer provides the FDA with detailed information about a new or modified device before it is sold. This allows the agency to review the device’s safety, effectiveness, and quality. Depending on the device type, the submission might be a Premarket Notification (510(k)) or Premarket Approval (PMA). The goal is to ensure that new medical devices are safe for patients and healthcare providers before entering the market. This process helps protect public health while allowing innovative medical technologies to reach consumers responsibly.