Our regulatory team will provide the highest quality FDA submissions. Element has experience with some of the most complex submissions and will ensure you are receiving the best support throughout the regulatory submission process. Our submission support includes but is not limited to:

• 510(k)s
• Pre-Submissions / Q-submissions
• Investigational Device Exemption (IDE)
• Humanitarian Device Exemption (HDE)
• Emergency Use Authorization (EUA)
• Breakthrough device designation
• Safer Technologies Program (STeP)
• De Novos