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
- Start Here! Webinar: An Introduction to FDA's Regulation of Medical Devices
- Welcome to CDRH Learn
- Device Advice: Comprehensive Regulatory Assistance
- Activities to Support Medical Device Innovators
- Get general help on a variety of device topics:
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
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
- CDRH Learn module: “In Vitro Diagnostics” CLIA Waiver Applications Draft Guidances from 1/9/2019
- Guidance: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Guidance: Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
I am working on a surgical and/or therapeutic device - where can I get started?
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?
- Overview: Digital Health Center of Excellence
- CDRH Learn module: “IT and Software” Digital Health from 2/24/2015
- Guidance: Digital Health Content
Companion Diagnostic Device
I am working on a companion diagnostic device where - can I get started?
- Overview: Companion Diagnostics
- Guidance: In Vitro Companion Diagnostic Devices
- Guidance: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Drug/Device Combination Product
I am working on a drug/device combination product - where can I get started?
- Combination Products Contacts
- Overview: Requests for Designation (RFD) Process to assign jurisdiction to for combination products
- Guidance: Combination Products Guidance Documents
- Guidance: Principles of Premarket Pathways for Combination Products
- Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
Premarket Submission Resources
What is the right premarket submission for my technology?
Investigational Device Exemption (IDE)
- Overview: Investigational Device Exemption (IDE)
- CDRH Learn module: “Clinical Studies/Investigational Device Exemption (IDE)” IDE Basics from 11/4/2014
- CDRH Learn module “Clinical Studies/Investigational Device Exemption (IDE)” Early Feasibility Study (EFS) Program from 8/18/2016
- CDRH Learn module: “Clinical Studies/Investigational Device Exemption (IDE)” Breakthrough Devices Program from 01/17/2019
- Overview: IDE Guidance
- Guidance: FDA Decisions for Investigational Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators
- Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies - Guidance For IRBs, Clinical Investigators, and Sponsors
- Taped presentation from REdI Spring 2018 Conference (May 15, 2018 Device Track) “De Novo Classification Requests”
- FDA De Novo database
- Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)
Premarket Notification 510(k)
- Overview: Premarket Notification 510(k)
- CDRH Learn module: “Premarket Notification (510k)” The 510(k) Program from 11/4/2014
- CDRH Learn module: “Premarket Notification (510k)” Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics from 11/1/2018
- Overview: How to Prepare a Traditional 510(k)
- Overview: How to Prepare an Abbreviated 510(k)
- FDA 510(k) Premarket Notification Database
- Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
- Guidance: Safety and Performance Based Pathway
Premarket Approval (PMA)
- Overview: Premarket Approval (PMA)
- Taped presentation from REdI Spring Conference (May 9, 2017 Device Track) “Introduction to the Premarket, Approval (PMA) Program”
- PMA Database
- Guidance: PMA Guidance Documents
- Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
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?
- Overview: Standards and Conformity Assessment Program
Read an overview of how to use consensus standards
- Standards: Resources and Use in Premarket Submissions
Watch a video on how to use consensus standards in premarket submissions
- Recognized Consensus Standards Database
Search the database to find consensus standards relevant to a particular technology
- Guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
How will I get paid for the technology that I develop?
- Early Payor Feedback Program
Obtain early payor input on your clinical evidence to support positive coverage decisions
- Innovators' Guide to Navigating Medicare
Learn about the Centers for Medicare & Medicaid Services (CMS)