Changes to an Existing Device – 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 Changes to an Existing Device – 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On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011.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Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’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.”

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