FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.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...Read More
The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”.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 AnswersRead More
