Medical Devices

  • BP meters, blood glucose monitors

  • The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

  • Establishment registration,

  • Medical Device Listing,

  • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),

  • Investigational Device Exemption (IDE) for clinical studies.

  • MEDICAL Devices

  • Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines.

  • Home Use Devices

  • Safety & Efficacy

  • Medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled, such as:

  • Adhesive bandages

  • Crutches

  • Eyeglass frames

  • Otoscopes

  • Personal Sound Amplification Products (PSAPs)

  • Sharps containers

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