Skip to content Skip to footer

USFDA 510k for In-Vitro Diagnostic Devices

USFDA 510k for IVDR

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. Here are the primary pathways for obtaining FDA approval for IVDs:

1. 510(k) Clearance:
  • Applicability: Most IVD devices are eligible for the 510(k) clearance pathway.
  • Process: Manufacturers must demonstrate that the new IVD device is substantially equivalent to a legally marketed predicate device. The FDA reviews the submission to assess safety and effectiveness.
  • Submission: The manufacturer submits a 510(k) premarket notification to the FDA.
2. De Novo Classification Request:
  • Applicability: IVD devices with low to moderate risk that do not have a suitable predicate for a 510(k) clearance may be eligible for De Novo classification.
  • Process: Manufacturers submit a request for the FDA to classify their device into Class I or II as appropriate, along with supporting data.
  • Submission: A De Novo request is submitted to the FDA.
3. Premarket Approval (PMA):
  • Applicability: High-risk IVD devices or those that are not eligible for 510(k) clearance may require a PMA.
  • Process: Manufacturers must provide extensive scientific and clinical evidence to demonstrate the safety and effectiveness of the device.
  • Submission: A PMA application is submitted to the FDA.
4. Emergency Use Authorization (EUA):
  • Applicability: In emergency situations, the FDA may grant EUA for IVDs for diagnosing, treating, or preventing serious or life-threatening diseases.
  • Process: The manufacturer must request an EUA from the FDA and provide data demonstrating the device’s performance and safety.
  • Submission: An EUA request is submitted to the FDA during public health emergencies.
5. Laboratory Developed Tests (LDTs): 

LDTs historically have been regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). However, the FDA has proposed a framework to regulate certain LDTs as IVD devices.

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. 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.
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.
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.

How can MAVEN, consultancy for USFDA 510(k) approvals be of assistance?

MAVEN, a consultancy for USFDA 510(k) approvals, specializing in regulatory affairs and quality management can play a crucial role in assisting manufacturers with the 510(k) approval process for In-Vitro Diagnostic (IVD) devices. Here are ways in which MAVEN can provide valuable support:

1. Regulatory Strategy Development:
  • Our USFDA 510(k) consultancy shall assist in developing a comprehensive regulatory strategy tailored to the specific characteristics of the IVD device.
  • Identify the most appropriate regulatory pathway (510(k), De Novo, etc.) based on device classification and intended use.
2. Pre-Submission Planning:
  • Conduct a thorough assessment of the IVD device and its regulatory history.
  • Assist in identifying suitable predicate devices for the 510(k) submission.
  • Provide guidance on data requirements, testing protocols, and documentation needed for the submission.
3. 510(k) Submission Preparation:
  • Prepare and compile the 510(k) submission package in accordance with USFDA requirements.
  • Review and refine technical documentation, including device descriptions, performance testing data, clinical studies, labeling, and instructions for use.
4. Pre-submission Interactions with the USFDA:
  • Facilitate pre-submission meetings with the USFDA to discuss the regulatory strategy, address questions, and seek guidance on potential issues.
  • Help establish a proactive and collaborative relationship with FDA reviewers.
5. Interactive Review Process:
  • Engage with FDA reviewers during the review process, addressing questions and providing additional information as needed.
  • Act as a liaison between the manufacturer and the FDA to ensure effective communication.
6. Quality Management System (QMS) Support:
  • Provide guidance on establishing and maintaining a robust QMS that complies with FDA Quality System Regulation (QSR) requirements.
  • Conduct internal audits to identify and address potential compliance issues.
7. Labeling and Instructions for Use:
  • Assist in developing clear and compliant labeling, including instructions for use.
  • Ensure that all necessary information is included to meet FDA expectations.
8. Post-Market Surveillance Planning:
  • Support the development of a post-market surveillance plan to monitor the performance of the IVD device after market entry.
  • Advise on adverse event reporting and compliance with post-market requirements.
9. Training and Education:
  • Provide training and education to the manufacturer’s personnel involved in regulatory affairs to enhance their understanding of compliance requirements.
10. Risk Management:
  • MAVEN shall assist in the identification, assessment, and management of risks associated with the IVD device throughout its lifecycle.
11. Compliance with Latest Regulations:
  • Stay informed about the latest FDA regulations, guidance documents, and changes in requirements, ensuring that the manufacturer is always aligned with current standards.
12. Preparation for FDA Inspections:
  • Prepare the manufacturer for potential FDA inspections by ensuring that all aspects of the quality system are in compliance.
13. Customized Solutions:
  • Provide customized solutions based on the unique characteristics and challenges of the IVD device and the manufacturer’s goals.

By leveraging the expertise of a USFDA regulatory consultancy, manufacturers can enhance their chances of a successful 510(k) approval for IVD devices, streamline the regulatory process, and ensure compliance with FDA requirements. It’s essential to choose a consultancy with experience in the specific regulatory landscape of IVD devices.