Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.
The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...
As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.
In touch with this trend, FDA has formed an Additive Manufacturing Working Group, and in October 2014, the Agency engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, according to ...
Blog Editors
Recent Updates
- DEA Issues Third Extension to Public Health Emergency Telemedicine Prescribing Flexibilities, Through 2025
- CMS Issuing First Risk Adjustment Data Validation Audit Notices for PY2018 Since the RADV Final Rule
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates
- Post-Hurricane Flexibilities Offered by the U.S. Department of Health and Human Services Through the Centers for Medicare & Medicaid Services