Choose and process materials as part of a device design and biological evaluation.

Output: Device Developers Outputs.

Applies to: Device Developers.

Feeds into: Device Developers Outputs.

Devices and evidence for patients, clinicians and reviewers.

Polymer materials for device and formulation developers.

FDA guidance describes biological evaluation in the context of a device risk assessment.

Describes resorbable polymers, development support and scale-up.

Explains risk-based biological evaluation of device materials; material data alone do not approve a device.