The FDA has added new information on our webpages about adverse event reporting requirements. The Electronic Medical Device Reporting (eMDR) System webpages help manufacturers, importers and health care facilities understand eMDR requirements…
On March 16, 2016, the FDA posted an updated version of the Sterility Final Guidance, originally published as final on January 21, 2016. The guidance was updated to correct an inadvertent…
Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” . Its recommendations seek to…
Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance…
Today, the FDA issued draft guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices to provide clarity on how the agency evaluates medical devices that electronically connect and interact with…
Today the FDA released a draft guidance document, “Unique Device Identification: Convenience Kits – Draft Guidance for Industry and Food and Drug Administration Staff ”. This document is intended to outline…
On December 3, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document, “eCopy Program for Medical Device Submissions,” that clarifies certain…
I am pleased to tell you about the exciting new developments at A Wright Path®, a reliable name in global regulatory compliance and strategy. We recently launched a new website…