Introduction to USFDA Regulation of Medical Devices |L-1| What is USFDA Regulation of Medical Device

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Introduction to USFDA Regulation of Medical Devices |L-1| What is USFDA Regulation of Medical Device@ivdmanufacturing7208

Part 1: What is the FDA’s Role in Medical Device Regulation?
Part 2: FDA Classification of Medical Devices
Class I (Low Risk)
"Class I devices are considered low-risk and include things like bandages, manual wheelchairs, and tongue depressors. These devices are subject to general controls but typically don’t require premarket approval from the FDA."
Class II (Moderate Risk)
"Class II devices carry a higher risk and may require 510(k) premarket notification to show they’re as safe and effective as a similar device already on the market. Examples include infusion pumps and diagnostic imaging equipment."
Class III (High Risk)
"Class III devices are the highest risk and require premarket approval (PMA). These devices must undergo the most rigorous testing before being approved. Examples include pacemakers, heart valves, and some cancer treatments."
Part 3: FDA Approval Process for Medical Devices
Premarket Notification (510(k)) for Class II Devices
"For many Class II devices, manufacturers need to submit a 510(k) submission. This is a premarket notification to show that the new device is substantially equivalent to a device that is already legally marketed. It’s a faster process than full premarket approval, but it still requires rigorous testing and documentation."
Part 4: Post-Market Surveillance and Monitoring
Part 5: Medical Device Reporting (MDR)


Premarket Approval (PMA) for Class III Devices
"Class III devices, like pacemakers and prosthetics, require Premarket Approval (PMA), which is much more detailed and requires clinical trials to prove the device is safe and effective. The PMA process is often lengthy and involves extensive data on the device’s design, manufacturing, and clinical performance."



Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices."

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
Quality System (QS) regulation,
Labeling requirements, and
Medical Device Reporting (MDRHow to Register Your Device with the USFDA?
Establishment Registeration
Device Listing
510K
PMA
Pre Market Notification
Classify Your Medical


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