Benjamin Wolf

Alston & Bird

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Latest Posts › Compliance

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Addressing Data Integrity Challenges in Medical Device Submissions

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

4/16/2025 / Audits , Compliance , Data Integrity , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Regulatory Requirements , Risk Management , Third-Party

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

1/14/2025 / Compliance , Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Notification Requirements , Public Health Emergency , Regulatory Requirements , Reporting Requirements

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

1/13/2025 / Compliance , Food and Drug Administration (FDA) , Manufacturers , New Guidance , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements , Risk Assessment

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