This document describes a method for collecting information regarding reportable events and filing the required reports for marketed medical devices. This procedure is specific for reporting to the FDA. This SOP adheres to 21CFR, Part 803. See 09-0178-SOP-1.0 for European reporting procedure.
Document identifier
DOXPUB 09-0179-SOP-1.0
Title
Medical Device Reporting: USA
DOXPUB Category
Regulatory Affairs
Publication date
2004-11-01
International Relationship
Latest version
DOXPUB 09-0179-SOP
History of version
DOXPUB 09-0179-SOP*DOXPUB 09-0179-SOP-1.0 * DOXPUB 09-0179-SOP * DOXPUB 09-0179-SOP-1.0
| Price |
100 vnd |
DOXPUB 09-0179-SOP-1.0
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