Medical Devices

Devices Used in Therapeutics

1. Types of devices used for TESTING / MONITORING and At-Home Test Kits discussed in this talk –

a. Blood Glucose monitors

b. Blood pressure monitors

c. Prothrombin Blood Coagulation monitors

d. Pregnancy test kits

e. and others

2. FDA Medical Device Classes

a. Class I = low to moderate risk to patient

i. 47% of devices

ii. 95% exempt

iii. Examples = Enema kits, elastic bandages, manual stethoscopes, and bedpans

b. Class II = moderate or high risk to patient

i. 43% of devices (most devices)

ii. Examples = powered wheelchairs, some pregnancy tests kits

c. Class III = high risk to patients

i. 10% of devices

ii. Examples = Implantable pacemakers, breast implants

d. FDA Regulatory Requirements

i. FDA Registration (21 CFR Part 807)

ii. Medical Device Listing

iii. Premarket Notification 510(k) OR Premarket Approval (PMA)

iv. Investigational Device Exemption (IDE) for clinical studies

1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

v. Quality System (QS) regulation

vi. Labeling requirements

vii. Medical Device Reporting (MDR)

3. Over-the-Counter use Tests

a. Regulation by the FDA in the In Vitro Test Database (IVD) Over-the-Counter Database

b. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

4. QS by FDA approved home and Lab Tests, laboratory validation

a. https://www.fda.gov/industry/regulated-products/medical-device-overview

b. https://www.pharmacytimes.com/publications/issue/2013/september2013/at-home-test-and-monitor-kits

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