FDA 510(k) Clearance & Premarket Approval

If you are planning to introduce a new device to the US market, we can support you in 510(k) clearance. We are FDA 510(k) submission consultants. We ensure the early acceptance of the 510(k) submission without RTA or AI and the successful clearance of the 510(k) submission. We provide expert advice, predictive device analysis, product code along with regulation number identification, preparation, Identification of testing requirement and standard, US Agent service, Q-Submission and FDA review response. We carefully plan and strategize 510(k) submission to ensure early acceptance of the 510(k) submission

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Our services includes:

• Register SBU (Small Business Unit), if applicable

• Device classifications

• Identification of relevant guidelines

• Identification and evaluation of predicate device

• Identification of device code and regulation number

• Applicable tests like performance test/bench test, sterilization and shelf-life tests, software tests, EMC (Electromagnetic compatibility) Tests

• Biocompatibility tests

• Performance test in animals

• Clinical trials

• Device labeling

• Create the technical dossier

• Pre 510(k) submission

• US Agent Appointment

• FDA 510(k) Submission in Hard copy and eCopy

• Post submission support in Resolving the queries and to get US FDA 510(k) approval

 

We also assist with the establishment registration and device listings.