Pre-submissions allow the FDA to provide initial comments on premarket approvals, humanitarian device exemptions, de novo petitions, and 510(k) submissions.
They are especially useful if there are concerns related to novel technology, testing, or the need for a clinical study, Patrick Antkowiak, a biomedical engineer in CDRH’s Office of Device Evaluation, said during an FDA-sponsored webinar.
One common problem is failing to provide enough information upfront. In particular, a lack of a device description, especially for devices the FDA has not previously reviewed under 510(k), may hinder meaningful discussion. As a result, a pre-submission should contain:
- A cover letter;
- Background information such as a general device description, bench/animal testing protocols, and clinical study protocols; and
- The proposed intended use and key aspects of the device design.
Pre-submissions for de novo devices also should specify the proposed class (Class I or II) and provide a discussion of the relevant regulations, a risk analysis, and proposed special controls. A pre-submission should not contain data, the CDRH official said.