Diagnostics

SOMA Diagnostic Consulting: Navigating FDA Regulations for In Vitro Diagnostic Devices

In the United States, the development and marketing of commercial tests are regulated by the U.S. Food and Drug Administration (FDA). These tests are classified as "medical devices," specifically as "in vitro diagnostic devices (IVDs)." Consequently, they must undergo evaluation and approval by the FDA.

An in vitro diagnostic medical device (IVD) can include reagents, calibrators, control materials, kits, specimen receptacles, software, instruments, apparatus, equipment, or systems, whether used alone or in conjunction with other diagnostic tools for in vitro use. According to the FDA, IVD products are intended for diagnosing disease or other conditions, assessing health status, and facilitating the treatment or prevention of disease and its complications. These products are designed for use in the collection, preparation, and examination of pecimens taken from the human body [21 CFR 809.3].

IVDs fall under the definition of devices as outlined in section 201(h) of the Federal Food, Drug, and Cosmetic Act and may also be considered biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to both premarket and post-market controls, as well as categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.

SOMA Diagnostic Consulting offers comprehensive FDA regulatory support for companies of all sizes, from small startups to large, multi-divisional corporations. Our team of experts provides fully tailored solutions to address your specific needs. With a focus on delivering services on time and within budget, our FDA consulting and project management teams ensure constant accessibility and support both on-site and off-site throughout the duration of your project.

• 510(k) Submissions: Assistance in obtaining FDA clearance for medical devices.
• Investigational Device Exemption (IDE) Submissions: Support for U.S. clinical studies involving IVDs.
• Requests for Classification and Determination: Guidance in navigating regulatory pathways.
• Pre-Submission (Pre-sub) Meetings: Facilitation of meetings with the FDA to discuss your device prior to submission.
• QSR Consulting: Quality System Regulation (21 CFR Part 820) consulting for medical device and IVD manufacturers.
• U.S. Agent Representation: Serving as a U.S. agent for manufacturers based outside the U.S.
• QSR Training: Training programs for medical device companies on quality system requirements.
• QSR Audits: Conducting audits for medical device companies and their suppliers to ensure compliance.
• Form 483 Warning Letter Support: Analysis, response, and recovery strategies for FDA 483s.
• General Regulatory and Quality System Assistance: Ongoing support and training in regulatory compliance.

At SOMA Diagnostic Consulting, we understand the complexities of navigating FDA regulations for IVDs. Our dedicated team is committed to helping you achieve compliance and bring your innovative diagnostic products to market efficiently.

Contact us today to learn more about how we can support your regulatory journey and ensure the success of your IVD products.