News & Analysis as of

Risk Management › Draft Guidance › Comment Period

Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Sheppard Mullin Richter & Hampton LLP on

Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

Fenwick & West LLP on

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on

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

Seyfarth Shaw LLP

New York State Releases The Draft Model Anti-Sexual Harassment Policy, Training, and Complaint Form

Seyfarth Shaw LLP on

Seyfarth Synopsis: In compliance with the New York State Anti-Sexual Harassment legislation passed earlier this year, the Office of Governor Andrew M. Cuomo has released drafts of the model sexual harassment policy, training...more

BakerHostetler

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

BakerHostetler on

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

Morgan Lewis

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

Morgan Lewis on

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

Mintz - Health Care Viewpoints

FDA Releases Draft Guidance for Medical Device Cybersecurity

Mintz - Health Care Viewpoints on

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

King & Spalding

FDA Issues Draft Guidance Governing Postmarket Cybersecurity Risk Management Standards

King & Spalding on

On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide