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Medical Devices › Regulatory Requirements › Data Integrity

Hogan Lovells

2025 NMPA Inspection points for clinical trials of medical devices

Hogan Lovells on

Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

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

Akin Gump Strauss Hauer & Feld LLP

FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns

Akin Gump Strauss Hauer & Feld LLP on

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and...more

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