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Device sponsors who want to supply real-world data to the FDA to support a product application need to consider how it can answer a specific regulatory question, advised Kristin Zielinski Duggan, partner at the law firm Hogan Lovells, in an FDAnews webinar. Read More
Outset Medical has received the first-ever approval under new Medicare rules that allow the federal program to pay for innovations in dialysis. Read More
After mulling mountains of data on Endologix’s AFX2 endovascular graft, an expert panel of the FDA’s Medical Devices Advisory Committee came to an unofficial conclusion: The stent — which has had a troubling propensity to fail — may be a good option in some small niche populations, but it’s not suitable for use in broad populations. Read More
Sponsors of some types of device software should file “enhanced documentation” as part of premarket submissions, the FDA says in a draft guidance released yesterday. Read More
The European Commission aims to increase the availability of notified bodies and designate EU reference laboratories as “essential actions” needed to ensure that the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) can take effect as planned on May 26, 2022. Read More
CellEra has received a warning letter from the FDA for not keeping written records of oral complaints about its drug-treated sterile wound dressings and not establishing a procedure to handle either oral or email complaints. Read More
The European Commission has ordered U.S. companies Illumina and Grail to keep their organizations separate and look into alternatives to Illumina’s planned $8 billion acquisition. Read More
Australia’s Therapeutic Goods Administration (TGA) is suing a medical device importer and its executive officers for the alleged unlawful importation of surgical face masks. Read More
The Advanced Medical Technology Association (AdvaMed) has developed a special code of ethics to govern dealings with healthcare professionals in India. Read More
Regeneron has persuaded the U.S. Patent Trial and Appeal Board (PTAB) to revisit a Novartis patent covering a syringe used in eye injections. Read More