The steps to FDA approval for a medical device

Medical devices play a huge role in the health-care industry. They are there to resuscitate patients, monitor vital signs, diagnose disease and give medical support when needed. Because they are responsible for maintaining, preserving and improving the lives of patients, it is vital that these medical devices perform properly. The U.S. Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective for use. It is no surprise that such a large government agency with such an important job has a strict set of rules and guidelines to follow when it comes to approving effective devices for medical use.

When working to approve a new medical device, many steps need to be followed precisely. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating the firms that manufacture, repackage, re-label and import medical devices that are sold in the United States. The device requirements follow a rigid set of guidelines in order to ensure quality and safety. While the class of a device will determine how strenuous the process is, gaining the FDA’s approval is not an easy task at any level. Be extra cautious when purchasing medical equipment from China that is not FDA Approved. Items that are sold on eBay and other websites could cause more trouble than the bargain is worth.

According to the FDA’s Device Regulation and Guidance Overview, the basic regulatory requirements for manufacturers of medical devices include:

  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 510(k) or Premarket Approval (PMA)
  • When FDA review is needed prior to marketing a medical device, the FDA will either:
    1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA or,
    2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) regulation
  • Labeling requirements
  • Medical Device Reporting (MDR)

Once a device has the approval of the FDA, then they can move forward with putting the device into practice. Medical Device Depot only sells FDA Approved medical equipment, so you can rest assured that you will have the best quality when your browse our selection of devices.

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