Month: April 2019

US FSA – Surgical staples – Guidance and proposed rules

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Draft Guidance for Industry […]

Commission Regulation (EU) 2019/319 of 6 February 2019 amending previous regulations as regards health certification at import into the Union concerning transmissible spongiform encephalopathies

Commission Regulation (EU) 2019/319 of 6 February 2019 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annex XV to Commission Regulation (EU) No 142/2011 as regards health certification at import into the Union concerning transmissible spongiform encephalopathies 

ISO 13485:2016 under systematic review

As can be seen in the ISO 13485:2016 page on the ISO website – the standard is under systematic review. Systematic review is required for each standard and deliverable from ISO. It helps in keeping the documents up-to-date. Usually, the systematic review is performed every 5 years, but due to some concerns, the systematic review […]