The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a
FDA Innovation Pathway – Tech that Address Unmet Med. Needs
Below is a copy from the FDA webpage on Innovation Pathway. Innovation Pathway Background on CDRH Innovation On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take
FDA Extends Comment Period on 510(k) Guidance
On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
E-Submissions Coming for Med Dvc & Pharma Mfrs
From AAMI News: July 2011: E-Submissions Coming for Medical Device & Pharmaceutical Manufacturers http://ht.ly/5y1ZQ
EU Interpretative Doc on Placing Med Dev’s on Mrkt
On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this