lunes, 30 de septiembre de 2019

Medical Device Webinars for October 2019

The FDA's Center for Devices and Radiological Health (CDRH) hosts webinars to help educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered.

Webinars scheduled for October 2019 include:

October 2: Dental Devices Premarket Submissions
October 16: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Final Guidance
October 21: Humanitarian Device Exemption Program
October 28: Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance
October 29: Collaborative Communities
October 31: The Special 510(k) Program: Final Guidance

Registration is not necessary for these webinars.

Questions? If you have questions about these webinars, contact the Division of Industry and Consumer Education.

Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions

Innovation in medical devices, spurred in many cases by advances in materials sciences, continues to improve the lives of patients. The growing number of available materials used in today’s medical devices ‒ such as metal, plastic, silicone, animal-derived products or some combination of these ‒ reflects continued evolution in this field that the U.S. Food and Drug Administration has routinely worked to evaluate as part of our ongoing commitment to foster safety and innovation to ensure that patients have access to safe and effective medical devices.

As part of our role in protecting patients, our staff regularly evaluates and monitors scientific evidence, as well as adverse event reports, to learn more about risks from devices—including those that may be related to the materials used in devices. In the case of medical device implants where materials may...