The FDA has announced a proposed update to its information collection process, now under review by the Office of Management and Budget (OMB) as part of the Paperwork Reduction Act of 1995. Importers, exporters, or manufacturers working with FDA-regulated goods should take note:
- Small Business Designation: To qualify for reduced or waived fees, your company must report $100 million or less in gross receipts or sales on your most recent federal tax return.
- First-Time Waivers: If your firm reports $30 million or less, you may be eligible to waive the fee on your first FDA premarket submission (including BLAs, PMAs, PDPs, and premarket reports).
- Form Updates: The FDA plans to consolidate multiple forms into a single webform and revise requirements for companies based in regions without a National Taxing Authority.
- Comment Deadline: Submit written feedback by July 9, 2025 here.
These updates aim to streamline the submission process and provide greater clarity around eligibility—but they also mean it’s time to review your documentation if you’re planning a submission.
