FDA-Recognized Third Party 510(k) Review Unit
Independent review of eligible Class II medical devices under the U.S. FDA Third Party 510(k) Review Program
Recognition granted under Section 523 of the U.S. Federal Food, Drug, and Cosmetic Act
Who We Are
SMO India Clinical Research Pvt. Ltd. is formally recognized by the U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) as a Third Party Review Organization under the FDA's Third Party 510(k) Review Program.
This recognition authorizes our Third Party Review Unit to conduct independent reviews of eligible Class I & II medical device 510(k) submissions, in accordance with FDA regulatory requirements.
What Is FDA Third Party 510(k) Review?
The FDA Third Party 510(k) Review Program allows FDA-accredited organizations to perform primary reviews of eligible Class II medical device submissions.
Key Program Elements:
- FDA remains the final authority for all 510(k) clearance decisions
- Third Party reviewers operate under defined FDA-recognized scopes
- Reviews follow the same regulatory standards applied by FDA
- The role is evaluation-only, not advocacy
Scope Limitations
Our Third Party Review Unit operates strictly as an independent regulatory evaluator and does not:
- •Author or prepare 510(k) submissions
- •Act as regulatory advocates
- •Interact with FDA on behalf of sponsors
- •Provide or imply guaranteed clearance outcomes
This independence is a core requirement of FDA recognition and is maintained across all Third Party engagements.
Services
FDA Third Party 510(k) Review Services
- Independent Third Party 510(k) reviews for eligible Class II devices
- Technical and regulatory evaluation aligned with FDA review expectations
- Structured review outputs suitable for FDA submission under the Third Party pathway
Note: Eligibility depends on FDA-defined product codes and scope.
Additional Regulatory Services
In addition to FDA Third Party reviews, SMO India provides regulatory readiness audits across multiple jurisdictions. These services are not part of the FDA Third Party program and are offered under our independent regulatory services.
- US FDA – 510(k) readiness audits
- CDSCO (India) – Regulatory submission readiness
- MHRA (UK) – UKCA readiness and regulatory gap assessments
Academic Partnerships
Our Third Party Review Unit actively engages with India's medical device innovation ecosystem to promote early regulatory clarity, including collaborations with leading academic institutions.
BETiC – IIT Bombay
Biomedical Engineering & Technology Incubation Centre
HTIC – IIT Madras
Healthcare Technology Innovation Centre
Note: These engagements are educational and readiness-focused and do not involve submission, authorship or regulatory advocacy.
Contact Information
For inquiries related to FDA Third Party 510(k) eligibility, Third Party review engagements, or regulatory readiness audits (US FDA, CDSCO, MHRA):
Inquiry Types
- • FDA Third Party 510(k) eligibility
- • Third Party review engagements
- • Regulatory readiness audits