(Post updated on 24 Jan 2013 for those that couldn’t access the LinkedIn Group, refer to 3rd paragraph below) Robert Packard, who is one of the managers of the LinkedIn Group “Medical Devices: QA/RA”, wrote recently on a subject that
FDA on Quest to Standardize Mandatory MedDvc Labeling
On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”. FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be
Joint Australia & New Zealand Therapeutic Products Regulatory Website
Information for this posting has been provided by a 29 November 2012 communique titled “Trans Tasman Ministerial Council progresses joint therapeutic products scheme” from the Australian Government – Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and
SFDA (China) Announces 17 New Device Classifications
The RAPS Regulatory Focus on 21 December 2012 posted an article in regard to the SFDA announcing 17 new device classifications. Click here to read the complete article.
FDA Issues Draft Guidance on MedDvcs Intended for Home Use
On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home