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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