United States of America
US FDA Medical Device Registration
The United States is among the world most stringently regulated markets for medical devices. With a regulatory framework dating back to 1976 and continuously refined since, the FDA Centre for Devices and Radiological Health (CDRH) governs the entire product lifecycle from development strategy through post-market compliance.
US FDA Medical Device Registration Overview
The United States of America represents one of the most prominent, stringently regulated medical device markets globally, featuring highly structured registration pathways and compliance prerequisites. The foundational medical device regulations in the U.S. were established in 1976 and have undergone significant evolution over the decades. Oversight and regulation are managed by the Centre for Devices and Radiological Health (CDRH), a specialized branch operating under the broader Food and Drug Administration (FDA). NKB Regovanta has partnered with numerous device manufacturers worldwide, successfully guiding them through the complexities of the US FDA medical device registration lifecycle.
Regulatory Authority
Food and Drug Administration (FDA)
Governing Regulation
Title 21 Code of Federal Regulations (21 CFR) Parts 800-1299
Registration Pathway
Premarket Notification (510k), Premarket Approval (PMA), or De-Novo Classification
Authorized Representative
QMS Requirement
Quality System Regulation (QSR) - 21 CFR Part 820
Technical Assessment Body
Centre for Devices and Radiological Health (CDRH)
License Validity
Unlimited
Labeling Requirements
21 CFR Part 801
Submission Format
Language
English
U.S. FDA Agent Requirement
Foreign device manufacturers that do not maintain an established place of business within the United States are legally required to designate a U.S. FDA Agent prior to initiating any registration or import activities. This agent — whether an individual or an organization — must be physically located within the United States and is responsible for serving as the FDA's primary point of contact with the manufacturer. The scope of the agent's responsibilities is formally defined under applicable CFR regulations and includes receiving regulatory correspondence, facilitating inspections, and supporting submission activities on the manufacturer's behalf.
The U.S. Agent plays a critical role throughout both the registration and post-market phases, and selecting an experienced agent with deep knowledge of FDA processes is strongly recommended for manufacturers new to the U.S. market.
Interactive Pre-Submission Meetings with the FDA
The FDA has established a structured Q-Submission (Q-Sub) program that allows device manufacturers to engage directly with CDRH reviewers at multiple stages of the product development and registration journey. These interactions — which include Pre-Submissions (formerly known as Pre-IDE meetings), Informational Meetings, and Study Risk Determinations — are designed to help manufacturers better understand regulatory expectations before committing to a specific development or submission pathway.
Engaging with the FDA through the Q-Sub process before initiating development activities or filing a formal registration application can provide clarity on classification, acceptable testing standards, clinical data expectations, and likely review timelines. This proactive approach has been shown to meaningfully reduce both the total cost and duration of the device commercialization process in the U.S.
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