Medical Innovation Exchange

draft guidance

FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices

FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices     The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of Human Factors Information in Device Marketing Submissions” draft guidance offers a risk-based …

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Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance     The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological …

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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. When finalized, “Computer Software Assurance for …

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