Pro Pharma Talks23 Tammi 2020

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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