Medical Device Legal News with Sam Bernstein: Episode 11
On August 7, 2025, the National Association of Insurance Commissioners’ Annuity Suitability (A) Working Group released draft safe harbor regulatory guidance that paints a clearer picture of how insurers should oversee third...more
In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This draft guidance is one of...more
Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug...more
On February 19, 2020, the Information Commissioner’s Office (ICO), the data protection regulator in the United Kingdom, launched a consultation on its draft guidance on the artificial intelligence (AI) auditing framework. ...more
On 4 September 2019 the U.S. State Department issued "Draft 'U.S. Government Guidance for the Export of Hardware, Software and Technology with Surveillance Capabilities and/or parts/know-how'" (draft guidance). ...more