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draft guidance

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices     On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Per the FDA’s announcement, the draft guidance …

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What You Need To Know About FDA Remote Medical Device Inspections

What You Need To Know About FDA Remote Medical Device Inspections     Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …

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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 The “Content of Human Factors Information in Device Marketing Submissions” draft guidance offers a risk-based …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Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance     The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children.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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device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