On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
Health Canada Final Guidance – Reprocessing & Sterilization:Reusable Med Dvcs
On June 1, 2011 Health Canada issued a notice releasing the final guidance on ‘Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.’ The following text has been taken straight from the Health Canada