Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.
A new draft guidance document from the US Food and Drug Administration makes recommendations about clinical trials and other research of devices intended to treat benign prostatic hyperplasia (BPH), a common form of age-related prostate enlargement.
The 25-page draft, issued on 14 July, is intended to replace some sections of a 2010 guidance document on BPH...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
