labeling Archives

Dec

New FDA Guidance – X-Ray

December 14, 2018Brian PateNews

FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018. A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...

Jan

FDA Draft medical Device product Communications

January 21, 2017Alan KusinitzNews

The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”. The full draft is at the link provided. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Sep

FDA Letter with extension of deadlines UDI

September 7, 2016Alan KusinitzNews

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf

New FDA Guidance – X-Ray

FDA Draft medical Device product Communications

FDA Letter with extension of deadlines UDI

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New FDA Guidance – X-Ray

FDA Draft medical Device product Communications

FDA Letter with extension of deadlines UDI

SoftwareCPR Training Courses:

Subscription Services

Corporate Office