The shift away from paper filings is expected to streamline the review process by making an electronic version of a medical device premarket application immediately available for review. The rule also reduces the number of copies required in electronic format, simplifying requirements and lowering expenses for submitters.
The final rule applies to:
- 510(k) premarket notifications
- Confidentiality of information certifications
- Investigational device exemption (IDE) applications
- Premarket approval applications (PMAs)
- PMA supplements
- Humanitarian device exemption (HDE) applications
FDA / Regulatory News
