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FDA Fact Sheet: Humanitarian Device Exemption (HDE)
FDA Fact Sheet: Premarket Approval Application (PMA)
FDA Fact Sheet: Premarket Notification (510(k))
FDA Fact Sheet: Medical Device Classification
FDA Fact Sheet: Investigational Device Exemption (IDE)
FDA Fact Sheet: Advisory Committees
Guiding Principles for Clinical Research in Chronic Wound Healing
Identification and Content Validation of Wound Therapy Clinical Endpoints Relevant to Clinical Practice and Patient Values for FDA Approval
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