Placing on the Market of Medical Devices – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Mon, 14 Nov 2011 06:18:23 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Placing on the Market of Medical Devices – Eisner Safety Consultants https://eisnersafety.com 32 32 FDA Extends Comment Period on 510(k) Guidance https://eisnersafety.com/2011/11/14/fda-extends-comment-period-on-510k-guidance/?utm_source=rss&utm_medium=rss&utm_campaign=fda-extends-comment-period-on-510k-guidance Mon, 14 Nov 2011 06:18:23 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2261 On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011.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Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’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.”

]]> EU Interpretative Doc on Placing Med Dev’s on Mrkt https://eisnersafety.com/2010/12/01/eu-interpretative-doc-on-placing-med-devs-on-mrkt/?utm_source=rss&utm_medium=rss&utm_campaign=eu-interpretative-doc-on-placing-med-devs-on-mrkt Wed, 01 Dec 2010 19:43:29 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=1940 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 applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic Medical Devices 98/76/EC.  Additionally, the biocidal products directive 98/8/EC is also referenced in this document.

This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008.  EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.

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