By Marco Theobald, Registrar Corp. The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA […]
FDA removed 10% of medtech establishments from its registration database: Here’s why
David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database. As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Get the full story on our sister site Medical Design & […]
FDA publishes final guidance for UDI direct marking requirements
David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. […]
FDA issues UDI compliance extension for certain Class II devices
By David Lennarz, Vice President and Co-Founder of Registrar Corp On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the […]
Last day to renew FDA medical device registrations for FY 2016
By David Lennarz, Vice President and Co-Founder of Registrar Corp In early February, the U.S. Food and Drug Administration (FDA) sent e-mails to medical device establishments that had not yet renewed their FDA registrations for fiscal year (FY) 2016. The e-mails state that “Failure to complete your annual registration by February 22nd, 2016, will result […]
2015 Year in review: FDA drug and device regulations
In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted electronically, including pharmaceutical product applications and adverse event reports for devices. FDA also opened an online database for the public to obtain information about devices. Read […]
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