Innovation Medical Device Special Review Dossier

Source: Innovation special review program / Notice 2018-127 related guide.
Chinese: 创新特别审查.

This package supports qualification for the innovation pathway. Approval does not replace registration/filing. After admission, still prepare the applicable initial registration or Class I filing dossier.

Typical contents: application form, enterprise qualifications, IP evidence, R&D summary, technical file, innovation/clinical-value evidence.