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The FDA has granted RevMedx’s request to move nonabsorbable expandable hemostatic sponges to Class II, but is requiring special controls to ensure the device is effective when used. Read More
CDRH is expecting a large number of devicemakers to take advantage of the Expedited Access PMA program proposed in draft guidance in April, center Director Jeffrey Shuren said during a Thursday webinar hosted by the Pew Charitable Trusts.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
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
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
Manufacturers will get more guidance on how to communicate off-label uses by the end of the year, the FDA said in a June 6 response to two citizen petitions. Read More
Results from Team-NB’s third member survey show the number of ISO 13485 certificates issued to devicemakers last year declined by 10 percent. Read More
The FDA’s recent approval of a gene-based diagnostic to improve blood matching before transfusions is just the first step for a technology that could vastly improve patient care, a panel of experts said recently. Read More
An audit of the FDA’s device review process recommends that the agency analyze the root cause of withdrawn submissions and create mechanisms to reduce their occurrence — good news for devicemakers fed up with inefficient reviews. Read More
The FDA has provided devicemakers with nitty-gritty details on how to set up and use the Global Unique Device Identification Database, a key component of the universal tracking system set to take effect for Class III implantable devices on Sept. 24. Read More