Washington Wrap-Up
Apr 01, 2014
By Jim Dickinson FDA says it plans to maintain its current overarching policy framework for determining when a 510(k) should be submitted for a modification to...
Apr 01, 2014
By Jim Dickinson On March 12, FDA published a guidance document, "Administrative Procedures for CLIA Categorization," to update an earlier document...
Apr 01, 2014
By Jim Dickinson                          FDA should include product codes in notices and...
Apr 01, 2014
By Jim Dickinson                               Several groups filed suit against FDA...
Apr 01, 2014
By Jim Dickinson                     On March 11, 2014, FDA granted de novo clearance to Cephaly Technology...
Apr 01, 2014
By Jim Dickinson                      When FDA’s current regulatory scheme for medical devices was...
Mar 10, 2014
By Jim Dickinson It has long irritated many in the medical device industry that the government agency that holds them to such stringent—even nit-picky...
Feb 26, 2014
By Jim Dickinson An FDA inspection at Amgen in Thousand Oaks, CA, last June found Quality System Regulation violations in the firm’s manufacturing of...
Feb 26, 2014
By Jim Dickinson                               A joint CDRH/CBER guidance issued...
Feb 21, 2014
By Jim Dickinson           Princeton, NJ-based attorney Michelle Yeary (Dechert LLP) says a California state court decision regarding...