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FDA GUIDANCE ON MEDICAL - GUIDANCE ON MEDICAL DEVICE PATIENT LABELING; FINAL GUIDANCE FOR INDUSTRY AND FDA REVIEWERS
HHS
A description is not available for this item.
FDA OFF-THE-SHELF SW - GUIDANCE FOR INDUSTRY, FDA REVIEWERS AND COMPLIANCE ON OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES
HHS
A description is not available for this item.
FDA PRE MARKET SUBMISSION - GUIDANCE FOR INDUSTRY AND FDA STAFF GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES
HHS
A description is not available for this item.
FDA FINAL REPORT - FDA FINAL REPORT OF THE COMMITTEE FOR CLINICAL REVIEW
HHS
A description is not available for this item.
FDA 95-4158 - PREMARKET NOTIFICATION 510(K) REGULATORY REQUIREMENTS FOR MEDICAL DEVICES
HHS
A description is not available for this item.
FDA MDQSM - MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE
NPFC
A description is not available for this item.
MEDICAL DEVICE QUALITY - MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE
NPFC
A description is not available for this item.
FDA 2/83 - GUIDE TO INSPECTION OF COMPUTERIZED SYSTEMS IN DRUG PROCESSING
HHS
A description is not available for this item.
FDA PREPARING NOTICES - PREPARING NOTICES OF AVAILABLITY OF INVESTIGATIONAL MEDICAL DEVICES AND FOR RECRUITING STUDY SUBJECTS
HHS
A description is not available for this item.
FDA FORM 3500A - MANDATORY MEDWATCH REPORTING FORM
HHS
A description is not available for this item.
FDA FORM 3417 - MEDICAL DEVICE REPORTING BASELINE REPORT
HHS
A description is not available for this item.
FDA 90-4236 - PREPRODUCTION QUALITY ASSURANCE PLANNING: RECOMMENDATIONS FOR MEDICAL DEVICE MANUFACTURERS
HHS
A description is not available for this item.
FDA G95-1 - USE OF INTERNATIONAL STANDARD ISO-10993, "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1: EVALUATION AND TESTING"
NPFC
A description is not available for this item.
FDA 97-4179 - MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE
NTIS
A description is not available for this item.
FDA GUIDANCE FOR INDUSTRY - GUIDELINE ON VALIDATION OF THE LIMULUS AMEBOCYTE LYSATE TEST AS ANEND-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES
HHS
A description is not available for this item.
FDA 88-4226 - MEDICAL DEVICE REPORTING QUESTIONS AND ANSWERS
HHS
A description is not available for this item.
FDA QS INSPECTION - GUIDE TO INSPECTIONS OF QUALITY SYSTEMS
HHS
A description is not available for this item.
FDA 7382.845 - INSPECTION OF MEDICAL DEVICE MANUFACTURERS
HHS
A description is not available for this item.
FDA 89-4203 - LABELING - REGULATORY REQUIREMENTS FOR MEDICAL DEVICES
HHS
A description is not available for this item.
