May 30, 2014 by MassDevice
US medical device market regulators are putting the burgeoning practice of 3-D printing for medical devices under the microscope, having announced a public workshop on the issue in October 2014 at the Food and Drug Administration’s headquarters.
The use of 3-D printing, also known as additive manufacturing, allows production of medical devices via computerized modeling rather than typical building materials. Read more
May 28, 2014 by MassDevice
The US Food and Drug Administration has published new online information explaining allowable exceptions and compliance deadline extensions medical device manufacturers may request regarding the agency’s new Unique Device Identification (UDI) requirements.
Manufacturers whose devices are registered with the FDA for sale in the US may submit requests for either exceptions or alternatives to UDI labeling or other requirements if the FDA determines that the rules are either technically unfeasible for particular devices, or if alternative labeling would allow more accurate device identification. In cases where exceptions or alternatives to UDI labeling are granted, however, the regulator may also prescribe additional safeguards or other conditions in order to ensure proper identification of devices in question. Read more
May 29, 2014 by MassDevice
By Charles Preston, M.D., MPH
Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH).
I had the privilege of representing the FDA at a recent steering committee meeting, and I am happy to report that this network, which includes countries from all over the Western Hemisphere, is ready to adapt to new challenges like globalization, and improve its effectiveness. Read more
May 28, 2014 by Brad Perriello
FzioMed said today that a dispute resolution panel slated for next month for its Oxiplex spinal surgery gel has been postponed so the FDA can review more clinical data.
The dispute resolution panel is on hold until the watchdog agency’s Center for Devices & Radiological Health deems the submission sufficient to support approval, according to a press release. If the CDRH, which agreed to review the new data within 90 days of receipt, deems the data insufficient FzioMed plans to renew the dispute resolution process during the 4th quarter, according to the release. Read more
June 2, 2014 by MassDevice
By Bakul Patel
Last month I blogged about a report outlining our proposed strategy and recommendations on an appropriate risk-based regulatory framework for health information technology (health IT). Issued by the Food and Drug Administration (FDA), the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), the report was followed by a three-day public workshop with consumer, patient, health care and industry stakeholders.
Our goals: to promote innovation, protect patients and avoid regulatory duplication. We just posted video of the workshop discussions online so that interested parties can view (or revisit) the events; a written transcript will follow. And public comments on the strategy and recommendations are open until July 7, 2014. Read more