FDA

According to Federal Food, Drug, and Cosmetic Act, each person must submit a premarket notification submission to the Food and Drug Administration (FDA) at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution 01 a device, unless the submission type of the device is Premarket Approval (PMA) or 510(k) exempt.

In addition, all the related firms, including but not limited to manufacture， contract manufacturer, contract sterilizer, importer and exporter and etc, are required to complete Establishment Registration and Medical Device Listing per 21 CFR part 807. AII foreign firms shall appoint a U.S. Agent during the establishment registration.

Services

 Pre-submission strategy consulting

 Determine appropriate predicate device per your product features

 Establish submission plan based on our experience

 Establish test plan, provide testing service, or recommend test laboratories

 Assist you in preparing the information required by 510(k)

 Complete the 51 O(k) submission documents

 Communicate with the designated review party

 Complete Establishment Registration and Medical Device Listing

 Act as your U.S. Agent

Furthermore, we have capabilities to assist you in establishing clinical protocol, software validation protocol, usability/human factor testing plan according to the FDA requirements , and provide targeted training based on your product and business situation.

Service for FDA