- Must comply with the quality system regulation to help ensure that products consistently meet applicable requirements and specifications.
- Must develop requirements for their products that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute their devices.
- Must comply with adverse event reporting requirements.
- Must correct problems voluntarily or at the request of the FDA.
The FDA is accepting comments on the 30-page proposed guidelines for 90 days.
Margaret Dick Tocknell is a reporter/editor with HealthLeaders Media.