Understanding the New Custom Device Exemption Guidance 2015 is a webinar that covers topics such as:
- Definitions
- Background of the new guidance
- Examples
- §520(b) of the Act, what changed
- Annual Report
- Documenting the decision
Understanding the New Custom Device Exemption Guidance 2015 is intended for:
- Project managers
- Regulatory or quality assurance management personnel
- Manufacturing and development management staff
- Staff involved with custom devices
