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FDA Device Regulations in 2014: A Year in Review

Over the past two days, Registrar Corp has published year in review blogs about FDA regulations for food and drug companies. Today we’re reviewing FDA’s medical device regulations and guidances established in 2014.

  • August 1:  FDA proposed to exempt over 100 devices from 510(k) requirements.  FDA indicated that it will not enforce 510(k) requirements for the proposed devices as the agency works to finalize the guidance.
  • August 22:  FDA granted a one year extension of the UDI labeling compliance date for most contact and intraocular lens labelers.  Lens labelers now have until September 24, 2015 to comply with the labeling requirements.
  • November 19:  FDA extended the UDI labeling compliance date for implant labelers.  Implant labelers now have until September 24, 2016 to comply with the labeling requirements.  Implant labelers still have to comply with the GUDID requirements by the original compliance date.
  • September 24:  The first UDI compliance date came around for Class III device labelers.
  • October 1: The annual registration period began for medical device companies.
  • October 2:  FDA opened inspection data to the public through its new data dashboard. Users can explore reports and trends in FDA inspections or view inspections by country.
  • December 5:  FDA issued a guidance for labeling products not made with latex.  FDA recommended that manufacturers use the statement “Not made with natural rubber latex.”
  • December 19:  FDA issued a guidance for labeling children’s laser toys.  FDA suggests that laser toy labelers use IEC Class I designation labeling when applicable so that buyers are informed of the minimal risk of the product.
  • December 22:  FDA issued a guidance for the transfer of 510(k) clearances.  If a device is sold to a new owner and the new owner does not significantly change the device, the new owner may use the same 510(k) obtained by the original owner.  The only requirement that FDA upholds for tracking 510(k) holders is for device manufacturers to list 510(k) numbers with their annual listing information.

Registrar Corp will continue to stay up-to-date on FDA news and regulations in 2015.  Sign up to receive Registrar Corp’s email updates or follow Registrar Corp on Twitter (@RegistrarCorp) for updates throughout the year.

For questions regarding U.S. FDA medical device regulations or to learn about Registrar Corp’s services for device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/livehelp.