FDA Looks To New Program To Ease Inspection Burdens For All – But Will Manufacturers Get On Board? / A new voluntary FDA program aims to relieve the inspectional load on manufacturers and the agency. Under the program, firms would submit to FDA a recent ISO 13485 audit report, along with other data, to gain a one-year reprieve from agency inspections. / “The Silver Sheet” April 2012

‘Regulators Forum’ Picks Up Where GHTF Left Off; Plans Include Creation Of Single-Audit Program / The International Medical Device Regulators Forum has identified a single-audit program as a top work item for the new organization. IMDRF is slowly taking over initiatives started by the Global Harmonization Task Force, which will close at the end of the year. / “The Silver Sheet” April 2012

FDA Warning Letters / H&H Wholesale Services cited for QS and MDR reg violations in relation to OneTouch and One Step Test Strips. / “The Silver Sheet” April 2012

FDA Close-Out Letters / Close-out letters posted on the agency’s website from March 13 through April 9. / “The Silver Sheet” April 2012

News In Brief / FDA will specify the types of devices subject to human factors data requirements in an upcoming guidance; researcher calls on FDA to create adverse event system for device interoperability. / “The Silver Sheet” April 2012