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U.S. PMA / De Novo Classification In the U.S., high-risk Class III medical devices require Premarket Approval (PMA), or medical devices whose marketing authorization cannot be obtained through 510(k) substantial equivalence with existing Class I or Class II medical devices. Our Services： Application strategy consulting
Establish a quality system conforming to 21 CFR Part 820
On-site support for FDA’s factory inspections
Submit applications for investigational device exemption (IDE)
Submit a pre-submission to the FDA
Prepare PMA application documents
Communicate with FDA scientific review staff on your behalf The U.S.FDA has established a special application pathway for low- and intermediate-risk products that cannot be marketed through the 510 (k) pathway due to a lack of comparator devices, known as De Novo Classification. Our Services: Application strategy consulting
Determine if the product is suitable for De Novo Classification
Submit a pre-submission to the FDA
Prepare De Novo Classification request
Communicate with FDA scientific review staff on your behalf |