Manufacturers, Pharmaceutical Industry, Safety Standards

Medical Device Cybersecurity Survey Report Released

Knobbe Martens on 4/26/2022

Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their...more

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

Hogan Lovells on 9/30/2019

On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

Troutman Pepper on 11/9/2017

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Product Liability Update: October 2017

Foley Hoag LLP on 10/19/2017

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

Robinson+Cole Health Law Diagnosis on 9/11/2017

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

International Product Liability Review - Issue 65

Hogan Lovells on 2/15/2017

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more