What you can do
- See a complete history of a registration (timeline + milestones).
- Track correspondence and required post-market commitments.
- Keep metadata up to date (type, class, jurisdiction).
Activity timeline
The timeline provides an audit trail of key milestones (submission, requests, determinations, renewals).Registration metadata
- Registration Type: Defines the nature of the submission (e.g., Initial Registration).
- Device Classification: Specifies the regulatory class assigned to the product (e.g., Class II).
- Country/Region: Identifies the geographic jurisdiction governing the registration (e.g., United States).
Commitments and correspondence
- Correspondence Management: Records all incoming and outgoing official communications, including Deficiency Letters, Submission Letters, and Approval Letters. Each entry identifies the status (e.g., Sent, Received) and the direction of the communication.
- Regulatory Commitments: Tracks mandatory post-market obligations such as Annual Post-Market Clinical Study Reports, Software Update Validations, and Labeling Revisions.
- Compliance Alerts: Dynamic status tags highlight urgent items (e.g., Overdue or Response Required) and prioritize tasks based on their impact level (High/Medium).
Actions
- Update Status: Manually modify the high-level standing of the registration based on new developments.
- Edit: Update technical metadata or registration identifiers (e.g., FDA K-numbers).
- Portal Access: Direct linkage to the official regulatory body’s submission portal for external verification or data retrieval.
- Add Commitment/Correspondence: Manually append new records to the registry to ensure the dossier remains comprehensive and current.