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FDA Regulations for Medical Device Approval in USA

  1. Establishment registration,
  2. Medical Device Listing,
  3. Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
  4. Investigational Device Exemption (IDE) for clinical studies
  5. Quality System (QS) regulation,
  6. Labeling requirements, and
  7. Medical Device Reporting (MDR)
  1. Manufacturers,
  2. Contract manufacturers,
  3. Contract sterilizers,
  4. Re-packagers and Re-labelers,
  5. Specification developers,
  6. Re-processors single-use devices,
  7. Remanufacturer
  8. Manufacturers of accessories and components sold directly to the end user
  9. U.S. manufacturers of “export only” devices
  10. Medical Device Listing

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of non-significant risk must be approved by the IRB only before the study can begin.

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.