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Healthcare Reform › Regulatory Requirements › Manufacturers

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

Stinson LLP on

This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

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