21 CFR Part 807- Establishment Registration
Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
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ISO 13485 Internal Auditor Checklist
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Modular PMA agreement with the FDA-Organizing each Module-Manufacturing Module-Class Audit of Manufacturing Facility up to 17 days
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IVD Validation & Clearance-What procedures are required-How to validate new systems-How to validate existing systems
510(k) Applications Made Simple
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510(k) Summary – Executive Summary-Financial Disclosure –Intended Use Statement-SE-Label Requirements
