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CDRH is expecting a large number of devicemakers to take advantage of the Expedited Access PMA program proposed in draft guidance in April, center Director Jeffrey Shuren said during a Thursday webinar hosted by the Pew Charitable Trusts. Read More
Prices for medical technologies grew on average just 1 percent per year over the past two decades, noticeably slower than other U.S. costs, new AdvaMed research shows. Read More
Medtech companies are under no obligation to correct misleading third-party statements or claims about their products made on social media, websites and online forums — even if the website is owned by the manufacturer. Read More
Devicemakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitation that Twitter imposes on messages, the FDA says. Read More
Stryker will use ongoing inquiries to continually assess its supplies for conflict minerals, according to a new supply chain policy outlined in the company’s first conflict minerals disclosure report to the SEC. Read More
During an FDA inspection, an employee of Precision Needle Manufacturing placed a bin of needle protectors on the ground and then later stacked the same bin on top of another container with exposed needle protectors, according to a Form 483. Read More
CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. While the company will need to improve staff training, the letter should not hurt operations or approvals, an analyst says. Read More