Issued: 05-01-2006 Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical

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Specifications	Issued: 05-01-2006 Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and \ Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use\ Devices Casper Uldriks
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Contains Nonbinding Recommendations Guidance for Industry and FDA Staff Compliance with Section 301 of the Medical Device Use

Specifications	Issued: 05-01-2006 Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and \ Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use\ Devices Casper Uldriks
Outline	I. Introduction The Least Burdensome Approach II. Consultation with Stakeholders III. Definitions
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Content	Contains Nonbinding Recommendations Guidance for Industry and FDA Staff Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices Document issued on: May 1, 2006 The draft of this document was issued on October 11, 2005. The information collection provisions in this guidance have been approved under OMB control number 0910-0577. This approval expires 3/31/2012. See additional PRA statement in Section IX of this guidance. For questions regarding this document contact Casper Uldriks at the Center for Devices and Radiological Health (CDRH) at 240-276-0106, or at casper.uldriks@fda.hhs.gov. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Compliance
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Issued: 05-01-2006 Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and \ Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use\ Devices Casper Uldriks

Issued: 05-01-2006 Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and \ Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use\ Devices Casper Uldriks

I. Introduction The Least Burdensome Approach II. Consultation with Stakeholders III. Definitions