Benjamin Wolf

Alston & Bird

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Latest Posts › Regulatory Requirements

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more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

What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices?

Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more

5/13/2024 / CLIA , Clinical Laboratories , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Regulatory Requirements

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more

1/25/2022 / Dietary Supplements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Labeling , Manufacturers , Marketing , Product Labels , Regulatory Requirements

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