Update on National Implementations of IEC 60601-1:2005

leoeisner — Sun, 29 Apr 2012 06:00:47 +0000

This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition. It is the top article on our Featured Articles WebPage. This article is on the National Implementations of IEC 60601-1:2005 for the EU under the MDD & AIMDD, Canada under the purview of Health Canada via the Canadian Medical Device Regulations (CMDR), United States of America under the purview of the Food & Drug Administration (FDA), and Brazil under the purview of the National Health Surveillance Agency (ANVISA).

Enjoy the article!

FDA Extends Comment Period on 510(k) Guidance

leoeisner — Mon, 14 Nov 2011 06:18:23 +0000

On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

Food & Drug Administration – Eisner Safety Consultants

Update on National Implementations of IEC 60601-1:2005

FDA Extends Comment Period on 510(k) Guidance