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FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE

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Welcome to The CRO Group, Inc., a global consulting organization for medical, biotechnology, and in vitro diagnostic device companies seeking ISO 13485 and CMDCAS registrations, CE Marking,  Part 11 assessments, validation, and remediation for Quality System  software,  EU Authorised Representative, FDA U.S. Agent,  software, 510(k) and international registrations services.

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MDR (21 CFR 803)

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RECENT STORIES:

FDA POSTPONES 2008 ESTABLISHMENT REGISTRATION

HEALTH CANADA REVISES GD-210 ISO 13485 GUIDE

GHTF RELEASES PROPOSED GUIDANCE ON STEDs

FDA PROPOSES REINSPECTION FEES

HEALTH CANADA RELEASES PRIVATE LABEL MEDICAL DEVICE GUIDANCE

EU MEDICAL DEVICE DIRECTIVE REVISION PROPOSAL

FDA REVISES 510(k) SOFTWARE PREMARKET SUBMISSION GUIDANCE