Get the Latest Regulatory Educational Materials from CDRH

Get the Latest Regulatory Educational Materials from CDRH The Division of Industry and Consumer Education (DICE) at the FDA’s Center for Devices and Radiological Health (CDRH) recently developed or updated the resources below to provide you the latest and most accurate educational information about medical devices and radiation-emitting electronic products. Device Advice CDRH recently posted these pages in Device Advice: A History of Medical Device Regulation & Oversight in the United States (8/27/2018) 510(k) Pilots (10/22/18) Reduced Medical Device Program Update (10/25/2018) Standards and Conformity Section (10/29/2018) PMA User Fee Refunds (12/12/2018) PMA Supplements and Amendments (12/14/2018) Accreditation Scheme for Conformity Assessment (12/14/2018) CDRH Learn

CDRH recently released the following learn modules in these categories: The Basics How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States (10/25/2018) Postmarket Activities Overview of the Quality System (11/19/2018) Production and Process Controls (11/19/2018) Documents, Change Control, and Records (11/19/2018) Radiation-Emitting Products How to Get Your Electronic Product on the U.S. Market (10/16/2018) 510(k) Third Party Program (for Third Party Review Organizations) 510(k) Third Party Review Program: Overview (10/16/2018) X-Ray Systems (10/16/2018)

View CDRH Learn List of Modules

Medical Device Webinars and Stakeholder Calls CDRH also hosts regulatory webinars and stakeholder calls for the medical device industry.View past recordings and upcoming listings.   Industry Basics Workshop Series On November 6, 2018, CDRH hosted an Industry Basics workshop on the Quality System covering these topics:   Production and Process Controls Documents, Change Control, and Records

View Workshop Video

Questions? If you have questions about regulatory educational materials or questions about medical devices or radiation-emitting electronic products, contact the Division of Industry and Consumer Education .