Here are some helpful links with time-saving online resources.
FDA Registration and Fees
- Registration & Listing Information
- Sec. 807.90 (Code of Federal Regulations Title 21)
- Electronic Registration & Listing System (FURLS)
- Establishment Registration and Medical Device Listing Files for Download
- Who must register and pay
- Medical Device User Fee Rates
- Medical Device User Fee Cover Sheet (Example)
FDA Database Search Pages
510(k) Submissions
- Device Advice
- How to Prepare a Traditional 510(k)
- Content and Format of a 510(k)
- Screening Checklist
- Submission Cover Sheet
- Financial Certification and Disclosure
- Guidance Financial Disclosure by Clinical Investigators
- 510(k) Review Template
- Is a new 510(k) required for a modification to the device?
- Refuse to Accept Policy for 510(k)s
HCPCS Level II Codes