Device labeling symbols on EU-marketed devices need to be accompanied by explanation, exec advises.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE LABELING SYMBOLS ON EU-MARKETED DEVICES need to be accompanied by explanatory text, Howard Dobbs, director of international regulatory affairs for Smith & Nephew North America, advised attendees at a June 4 session of the Medical Design and Manufacturing East conference in New York City. Dobbs said that symbols must be explained because the European Commission has not yet harmonized a European Standard for symbols. The issue is particularly problematic in light of the June 14, 1998 implementation date for the EU's Medical Devices Directive (MDD). Compliance with the directive has been optional since January 1995 ("The Gray Sheet" July 17, 1995, p. 20).
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.