Per Eucomed’s 7 October 2011 newsletter electronic labeling of medical devices (MDD & AIMDD) has been approved as a draft regulation and is in the hands of “the Council and European Parliament who will have 3 months to exercise their
Update on DRAFT NB-MED EN60601 3rd ed. Implementation for EU
16 Jan 2012 Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are: 1) Substantial progress has been made over the last couple months
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
GHTF to morph into Int’l Med Dvc Regulators’ Forum (IMDRF)
The GHTF has been around for almost 20 years and is in the process of disbanding to become a more Regultor focused group called the International Medical Device Regulators’ Forum (IMDRF). In the Eucomed 18 Nov 2011 newsletter article they
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On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October