IMPORTANT INFORMATION ABOUT 510(K) PREMARKET NOTIFICATIONS

Documents required for a 510(k) submission:

1. Descriptive information: Theory of operation, schematic and construction diagrams, photographs, packaging, service manuals. Proprietary information should be marked "Confidential and Proprietary."

2. Testing information: Sterilization information (if applicable), biocompatibility, safety, performance, clinical, electromagnetic compatibility, compliance with applicable standards.

3. Any testing or information required by Guidance Document or FDA Recognized Standards.

4. Software information (if applicable)

5. Wirless information (if applicable)

6. Comparison to similar devices legally marketed in the USA (i.e. predicate devices). We can assist with this.

7. Risk analysis. We can assist with this.

8. Labeling, including brochures, users manuals, and labels on the device.

Documents in electronic format such as Word or Acrobat pdf are preferred. Certain image formats are acceptable.

Medical Device User Fees payable to FDA.

Fees must be submitted to FDA before sending the 510(k) or PMA submission to FDA. Medical Device User Fees Reduced fees (except for annual registration) are available for certain small businesses. To qualify for the small business rate, the company must submit Federal income tax forms (for itself, and all affiliates, partners, and parent firms), showing that its annual sales and receipts do not exceed $100 million. Foreign businesses can now qualify as a small business. There are some exemptions from fees, for example devices used solely for pediatric use. Call or email for details and an application form.