SMO India Clinical Research Pvt. Ltd. (SMO India) has been formally recognised by the U.S. Food and Drug Administration (FDA), Centre for Devices and Radiological Health (CDRH), as a Third-Party Review Organisation authorised to conduct independent reviews of eligible Class I and Class II medical devices under the 510(k) pathway. The recognition, granted on February 11, 2026, followed a formal assessment of SMO India’s technical competence, reviewer qualifications, and compliance systems under the FDA’s Third-Party Review Program.
With this recognition, SMO India becomes one of a select group of organisations globally authorised under the FDA’s Third-Party Review Program, operating as part of a trusted network of independent evaluators within the FDA framework.
For eligible devices, manufacturers may submit their 510(k) applications to SMO India for independent review. SMO India conducts FDA-aligned evaluations and forwards its review and recommendation to the FDA, which retains final clearance authority. This enables manufacturers to access a more efficient and structured review pathway without compromising regulatory rigour or patient safety.
Core Capabilities: Regulatory Readiness and Independent 510(k) Review
SMO India’s capabilities are centred on regulatory readiness audits and independent evaluation, supporting medical device manufacturers in preparing for global regulatory submissions.
These include:
Independent Third-Party 510(k) Review for eligible Class I and Class II devices under the FDA’s Third-Party Review Program
Regulatory Readiness Audits aligned to:
U.S. FDA requirements
CDSCO (India) regulatory framework
MHRA (United Kingdom) requirements
SMO India operates strictly as an independent evaluator within defined regulatory frameworks, focusing on assessing the completeness, alignment, and robustness of quality systems and technical documentation against applicable regulatory expectations.
Strengthening India’s Role in Regulatory Science
The presence of an FDA-recognised Third-Party Review Organisation in India represents a significant advancement for the country’s medical device ecosystem. It enhances India’s role in global regulatory science by enabling access to independent evaluation capabilities aligned with international standards.
