A guide to the steps companies can take to evaluate their device developer’s HFE process.
The device should be carefully matched to end users, rather than be an afterthought.
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
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.
Some key factors that companies should not overlook when developing drug-device products.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.
The process gives sponsors the ability to interact more with FDA.
Start-up Ariste Medical has developed technology to reduce surgical site infections and transform implants into combination products.
The agency is creating a virtual center of excellence to expedite the development of combination products.