Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in s…
Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for the Drug Supply Chain Security Act (DSCSA) traceability requirements to ensure continuity of the supp…
The U.S. Food and Drug Administration (FDA) continues to work through the redesign of its organizational structure into one unified Human Foods Program (HFP) and recently highlighted its dietary supplements program as a critical priority. In an upd…
The risk of product recalls across five key industries remains prevalent in the U.S. according to data from Sedgwick’s latest Recall Index report. Despite recall activity falling less than one percent in Q2 2023 compared to the previous quarter, at o…
European product recalls increased 7.8% in the second quarter of 2023, marking a fourth consecutive quarter of aggregate growth across the automotive, food and beverage, pharmaceutical, medical device and consumer product sectors. According to Sedgwi…
In early August, the government of the United Kingdom released 13 proposals to change product safety. While stakeholders have been expecting these proposals for a while now, a few of the changes came as a surprise to regulatory experts because they c…
The U.S. National Highway Traffic Safety Administration (NHTSA) indicated that it plans to publish a notice of proposed rulemaking on automated driving systems (ADS) this fall. Simultaneously, several members of the U.S. House of Representatives are …
Last month, the European Academy of Paediatrics and 22 other medical associations wrote a letter to the EU Health Commissioner, urging the correction of the new EU Medical Devices Regulation (MDR). They warned that the regulation has led to a shortag…
As technology rapidly evolves, cybersecurity has become indispensable in many industries. As the risk of cyberattacks infiltrates the healthcare industry, U.S. Congress is pressured to take action. As a range of medical devices — IV pumps, MRI …
On July 6, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that will be a priority for the …
Fixed recoverable costs (FRC) may cause ripples in litigation matters beginning in October 2023. An extension of the FRC regime will result in coverage of a wider range of investigations in the UK. In this podcast, we are joined by Paul Squires, part…
Artificial intelligence (AI) is everywhere, but it has largely been unregulated to this point. The European Union is looking to change that with its proposed EU AI Act. The European Parliament took a major step forward in AI regulation at the beginni…
The U.S. Consumer Product Safety Commission (CPSC) has long prioritized protecting children’s safety as it relates to the use of consumer products, and that commitment is clear with the agency’s recent activity around secondary markets. Latest devel…
Data from the first quarter of 2023 shows that product recalls across the U.S. automotive, consumer product, food and beverage, medical device, and pharmaceutical industries increased 14.2% from the previous quarter. As reported in Sedgwick brand pro…
European product recalls increased 6.1% in the first quarter of 2023, according to Sedgwick brand protection’s latest European recall index report. In total, the European automotive, consumer product, food and beverage, pharmaceutical, and medical de…