Archive for May 2019
FDA Urged to Clarify Voluntary Quality Standards for Combination Products
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Source: Drug GMP Report
Read MoreFDA Scraps Biannual Biologics Inspections for Risk-Based Approach
The FDA is scrapping requirements that biologics be inspected at least every two years, moving instead to a risk-based schedule. Source: Drug GMP Report
Read MoreFDA Issues List of Class 1 Accessories
The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Source: The GMP Letter
Read MoreFDA Clarifies Labeling Identifier Rules for Convenience Kits
The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance. Source: The GMP Letter
Read MoreCombination Products Get Extra Year for Postmarket Safety Compliance
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Source: The GMP Letter
Read MoreFDA Issues Final Guidance on Bench Performance Testing
The FDA issued final guidance recommending what information devicemakers should include in test report summaries, test protocols and complete rest reports for non-clinical bench performance testing for their premarket submissions. Source: The GMP Letter
Read MoreCDRH Flags Ongoing Concerns Over Contaminated Duodenoscopes
CDRH Director Jeff Shuren said the center is considering regulatory actions because of ongoing concerns over contaminated duodenoscopes. Source: The GMP Letter
Read More483 Roundup: FDA Flags Three Firms for Quality, Other Issues
The FDA cited three devicemakers for nonconforming products, documentation failures, inadequate CAPAs and numerous other problems found during agency inspections. Source: The GMP Letter
Read MoreFDA Addresses Safety Concerns for Surgical Staplers and Staples
The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use. Source: The GMP Letter
Read MoreEuropean Commission Releases Details on Eudamed, Nomenclature System
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Source: The GMP Letter
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