CDRH: What is the right premarket submission for my technology?

Investigational Device Exemption (IDE) Resources

FDA webpage giving IDE overview

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

CDRH Learn module “Clinical Studies/Investigational Device Exemption (IDE)” Breakthrough Devices Program from 01/17/2019

FDA webpage with list of guidances related to IDEs

Download FDA Decisions for Investigational Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff – August 2014

Download Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies – January 2006

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De Novo Resources

CDRH Learn module “De Novo” De Novo Classification Process (Evaluation of Automatic Class III Designation) from 11/21/2017

Taped presentation from REdI Spring 2018 Conference (May 15, 2018 Device Track) “De Novo Classification Requests”

FDA De Novo database

Download De Novo Classification Process (Evaluation of Automatic Class III Designation) Guidance for Industry and Food and Drug Administration Staff – October 2017

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Premarket Notification 510(k)Resources

FDA webpage giving 510(k) overview

CDRH Learn module on “Premarket Notification (510k)” The 510(k) Program from 11/4/2014

CDRH Learn module on “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

FDA webpage on preparing a traditional 510(k)

FDA webpage on preparing an abbreviated 510(k)

FDA 510(k) database

Download The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff – July 2014

Download Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration – February 2019

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Premarket Approval (PMA) Resources

FDA webpage giving PMA overview

Taped presentation from REdI Spring Conference (May 9, 2017 Device Track) “Introduction to the Premarket , Approval (PMA) Program”

FDA PMA database

FDA webpage with list of guidances related to PMAs

Download Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance for Industry and Food and Drug Administration Staff from 02/2019

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

CDRH Learn module “Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)” Humanitarian Use Device (HUD): Program Overview

CDRH Learn module “Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)” Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities

FDA HDE database

Download Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designation– January 2013

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Updated Date:

October 5, 2020