Abiy Desta and Ken Skodacek serve as CDRH’s Ombudsman and Deputy Ombudsman. CDRH thanks them for all they do …read more
Product News Update
Providence Enterprise Limited
Category: FDA Press
Abiy Desta and Ken Skodacek serve as CDRH’s Ombudsman and Deputy Ombudsman. CDRH thanks them for all they do for CDRH and the @US_FDA. Happy #OmbudsDay!pic.twitter.com/LVlHGdL3tt
Posted in FDA Press
Its #OmbudsDay! But what’s an Ombudsman? An ombudsman is one who assists individuals and groups in the resolution of conflicts or concerns. Ombuds work in all types of organizations, including government agencies.
Its #OmbudsDay! But what’s an Ombudsman? An ombudsman is one who assists individuals and groups in …read more
Posted in FDA Press
Ombuds: Unusual name. Important service. The CDRH Ombudsmen investigate complaints from outside @US_FDA and facilitates the resolution of disputes between CDRH and the industry it regulates.
Ombuds: Unusual name. Important service. The CDRH Ombudsmen investigate complaints from outside @US_FDA and facilitates …read more
Posted in FDA Press
#DYK today is #WorldHealthDay? A global health awareness day led by @WHO , and other related organizations. Check out how CDRH works with countries from around the world to ensure citizens have access to safe and effective medical devices here in the U.S. https://go.usa.gov/xQ4K7 pic.twitter.com/0HehLVpwxz
#DYK today is #WorldHealthDay? A global health awareness day led by <a class="colorbox" …read more
Posted in FDA Press
Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M
Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M …read more
Posted in FDA Press
#Recall – Penumbra Inc. 3D Revascularization Device: Wire Material May Break or Separate During Use https://go.usa.gov/xRDsu #fda
#Recall – Penumbra Inc. 3D Revascularization Device: Wire Material May Break or Separate During Use …read more
Posted in FDA Press
Federal Register: Electronic Submission of Labeling for Certain Home-Use Medical Devices
The FDA is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require …read more
Posted in FDA Press
Federal Register: Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
The FDA is classifying the apical closure device into class II (special controls). The special controls that will apply to …read more
Posted in FDA Press
Webinar – Draft Guidance: 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions' – July 11, 2016
This draft guidance released on June 15, 2015, focuses on the factors the FDA may consider when making decisions related …read more
Posted in FDA Press
Class I Medical Device Recall: Customed Inc., Surgical Convenience Packs – Damaged Packaging
Surgical pack sterility may be compromised due to individual packs adhering to one another inside the shipping case. In some …read more
Posted in FDA Press