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FDA Center for Devices and Radiological Health (CDRH)

The US Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness, and develops and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.

Getting Started with CDRH

Is my technology considered a class I, II, III device?

Medical Device Classification Overview
Understand how to determine your device’s classification

FDA Product Classification Database
Search the classification database to learn how similar devices were classified

Resources by Technology Category

The resources below are to connect entrepreneurs with a set of curated links available from the United States Food and Drug Administration (FDA) and contain links to resources that are relevant for early-stage companies developing oncology-related technologies.

In Vitro Diagnostic

I am working on an in vitro diagnostic - where can I get started?

Clinical Laboratory Improvement Amendments (CLIA) Waiver resources

Surgical/Therapeutic Device

I am working on a surgical and/or therapeutic device - where can I get started?

Imaging Device

I am working on an imaging device - where can I get started?

Digital Health Technology

I am working on a digital health technology - where can I get started?

Companion Diagnostic Device

I am working on a companion diagnostic device where - can I get started?

Drug/Device Combination Product

I am working on a drug/device combination product - where can I get started?

Premarket Submission Resources

What is the right premarket submission for my technology?

Investigational Device Exemption (IDE)

De Novo

Premarket Notification 510(k)

Premarket Approval (PMA)

Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE)

Frequently Asked Questions (FAQs) about CDRH

Does my technology qualify for an expedited regulatory program?

Overview: Breakthrough Devices Program
Read an overview of the breakthrough device program to determine if your technology is eligible for expedited review

What standards should I consider when testing my technology?

How will I get paid for the technology that I develop?

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