Secure USFDA approval for In-Vitro Diagnostic Devices effortlessly. Your pathway to compliance and market success starts here! In the United States, In-Vitro Diagnostic devices require regulatory approval or clearance from the U.S. Food and Drug Administration before they can be legally marketed and sold. The specific regulatory pathway depends on the classification of the IVD device. https://mavenprofserv.us/usfda-510k-for-in-vitro-diagnostic-devices/

1. USFDA 510k for In-Vitro
Diagnostic Devices
www.mavenprofserv.us

2. The primary pathways for obtaining FDA approval for IVDs
Classification of In-Vitro Diagnostic (IVD) devices as per
USFDA
How can MAVEN, consultancy for USFDA 510(k) approvals be
of assistance?
Overview

3. In the United States, In-Vitro Diagnostic (IVD) devices require
regulatory approval or clearance from the U.S. Food and
Drug Administration (FDA) before they can be legally
marketed and sold. The specific regulatory pathway depends
on the classification of the IVD device.

4. The primary pathways for obtaining FDA
approval for IVDs
1.510(k) Clearance
2. De Novo Classification Request
3. Premarket Approval (PMA)
4. Emergency Use Authorization (EUA)
5. Laboratory Developed Tests (LDTs)

5. Classification of In-Vitro Diagnostic (IVD)
devices as per USFDA
The classification of In-Vitro Diagnostic (IVD) devices in the United
States is based on the level of risk associated with the device. The
U.S. Food and Drug Administration (FDA) classifies medical devices
into three main classes: Class I, Class II, and Class III. The
classification system is outlined in the Code of Federal Regulations
(CFR), specifically in 21 CFR Part 862-892 for IVD devices.

6. Here’s a general overview of the classification criteria:
Class I IVD Devices:
Low to moderate risk.
General controls are usually sufficient to ensure safety
and effectiveness.
Examples include certain general laboratory equipment,
general-purpose reagents, and simple testing kits.

7. Class II IVD Devices:
Moderate risk.
Special controls, in addition to general controls, are
necessary to provide reasonable assurance of safety and
effectiveness.
Examples include enzyme-linked immunosorbent assay
(ELISA) test kits, certain blood glucose monitoring devices,
and home pregnancy test kits.

8. Class III IVD Devices:
High risk.
Require premarket approval (PMA) to ensure safety and
effectiveness.
Examples include certain high-complexity tests, companion
diagnostics, and devices for assessing the risk of specific
medical conditions.

9. 1.Regulatory Strategy Development
2.Pre-Submission Planning
3.510(k) Submission Preparation
4.Pre-submission Interactions with the USFDA
5.Interactive Review Process
How can MAVEN, consultancy for USFDA
510(k) approvals be of assistance?

10. 6. Quality Management System (QMS) Support
7.Labeling and Instructions for Use
8.Post-Market Surveillance Planning
9.Training and Education
10.Risk Management
11.Compliance with Latest Regulations
12.Preparation for FDA Inspections
13.Customized Solutions

11. Contact Us
https://mavenprofserv.us/usfda-510k-for-in-
vitro-diagnostic-devices/
md@mavenprofserv.us