FDA Letter On X-ray Servicing Software Should Be Retracted - Petition
This article was originally published in The Gray Sheet
Executive Summary
FDA's letter on servicing software, sent to manufacturers of diagnostic x-ray components Dec. 24, violates the agency's Good Guidance Practices and therefore should be retracted, the Washington, D.C. law firm of Hyman, Phelps & McNamara states in a Feb. 5 letter to FDA.