Medical Device Legal News with Sam Bernstein: Episode 11
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more
The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more
Polsinelli is pleased to share the Health Care Reimbursement and Payor Dispute Update. This newsletter is a designated source of news, information and guidance on the constantly evolving reimbursement industry. ...more
Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more
The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the...more
On 22 November 2018, HM Treasury published Explanatory Information on the draft Financial Services and Markets Act 2000 (Amendment) (EU Exit) Regulations 2019 (the “Draft FSMA Regulations“)....more
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more
On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more
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
The State of New York recently issued draft guidance for employers regarding the anti-sexual harassment legislation passed earlier this year....more
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced...more
The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more