https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc?utm_campaign=2020-06-19%20Updated%20Guidance%20Section%20506J&utm_medium=email&utm_source=Eloqua

Updated Guidance: Notifying CDRH Under Section 506J During the COVID-19 Public Health Emergency

The U.S Food and Drug Administration (FDA) updated the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, to facilitate notification regarding device manufacturing interruptions or discontinuance. The FDA updated this guidance to announce availability of a list of device types that FDA recommends manufacturers consider in determining whether a notification under Section 506J of the FD&C Act is required during the COVID-19 pandemic. The guidance, along with additional web resources, is intended to provide recommendations and help medical device manufacturers understand: When the FDA must be notified pursuant to Section 506J of an interruption or discontinuance in manufacturing What device types and corresponding products codes the FDA recommends manufacturers consider in determining whether they are required to notify the FDA under Section 506J How to notify the FDA of an interruption or permanent discontinuance in manufacturing

Read More Questions? If you have questions about this guidance, email CDRHManufacturerShortage@fda.hhs.gov and please begin the email subject line with the word "Question" to expedite our response.