Applicants shall submit complete PMA dossiers to FDA with core contents as follows:
Technical sections: detailed device description, working principle and manufacturing information.
Non-clinical laboratory study data: biocompatibility, bench performance tests, animal trials and others.
Clinical study data: pivotal clinical trial results proving safety and effectiveness.
Draft labeling: instructions for use, contraindications, warnings, etc.
Risk management documentation.
Financial disclosure information (to avoid conflicts of interest among clinical investigators).
Acceptance review: FDA confirms whether the application is complete enough to initiate substantive review.
Substantive review: It is stringent with rigorous clinical trial assessments, resulting in an overall lengthy review cycle.
Interaction and supplemental information: FDA may issue information requests, requiring timely responses from applicants.
Inspection (as applicable): FDA may conduct on-site inspections at clinical trial sites and/or manufacturing facilities.
