News & Analysis as of

Data Protection Draft Guidance Food and Drug Administration (FDA)

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

McDermott Will & Emery

FDA Proposes Rule to Update Clinical Trial Data Monitoring

McDermott Will & Emery on

On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Hogan Lovells

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Holland & Knight LLP

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Hogan Lovells

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

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