SUD Petition: Add Electrosurgical Cutting, Coagulation Devices To List II
This article was originally published in The Gray Sheet
Executive Summary
Reprocessors of single-use electrosurgical cutting & coagulation devices will need to submit additional validation data if FDA grants a recent petition filed by law firm Hyman, Phelps, & McNamara
You may also be interested in...
Biopsy Forceps Review Request Prompts Category Change For Nine SUDs
Reprocessed single-use non-electric biopsy forceps will no longer be considered 510(k)-exempt devices, meaning that reprocessors will need to file premarket notification and validation data with FDA by July 30, 2004
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.