The rise in cancer cases has led device companies to form partnerships to distribute their products in the region.
Companies should not underestimate the importance of investing in user experience design.
Healthcare providers are being warned about an increased rate of adverse cardiac events, as the agency conducts additional analyses.
The president’s selection is drawing criticism due to reported ties with the pharmaceutical industry.
Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
Fewer resources and more requirements are hindering the process.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
Several provisions are aimed at accelerating device innovation and access to medical products.
FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.