FDA Structure and Submission Types Overview

FDA Centers

Includes Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and others.

Drug Applications

Various types include IND, NDA, ANDA, BLA, and OTC drug applications with specific requirements.

FDA Offices

Entities like Office of Regulatory Affairs, Office of Women's Health, and others within the FDA.

Medical Device Applications

Types include 510(k), PMA, De Novo, and HDE applications with distinct evaluation criteria.

Combination Products

Products like drug-coated stents, insulin pumps, etc., with regulatory pathways based on primary method of action.

Breakthrough Devices Program

A program expediting approval for devices treating life-threatening conditions with rigorous safety standards.

User Fees

FDA funding mechanism varying by submission type, entity size, and increasing over time.