IMPORTANT INFORMATION ABOUT 510(K) PREMARKET NOTIFICATIONS 

The Following Documents are required:  
(1) Descriptive information:  theory of operation, schematic and construction diagrams, photographs, packaging, service manuals.  Proprietary information should be marked "CONFIDENTIAL."

(2) If there is an FDA guidance document for the device, all information required by that guidance. 

(3) Testing information:  biocompatibility, safety, performance, clinical, electromagnetic compatibility, compliance with applicable standards.  Any testing required by Guidance Document.

(4) Software information (if applicable)  Link to software guidance.

(5) Sterilization information (if applicable)

(6) Labeling, including brochures, users manuals, and labels on the device.  Drafts are OK.

(7) Status of CE, regulatory approval, free sale certificates and other quality system certificates, e.g. ISO9000 or ISO 13485

(8)Comparison to similar devices.  We can assist with this.

(9) Risk analysis.  We can assist with this.

Documents in electronic format such as Word or Acrobat pdf are preferred.

Medical Device User Fees payable to  FDA .    

Fees must be submitted to FDA before sending the 510(k) or PMA submission to FDA. This is in addition to the fee charged by Achevé Technology, Inc. to produce your 510(k) or PMA. Link to information on Medical Device User Fees .      The regular 510(k) fee will be  $3,502 as of 1 October 2004 . The fee for small business will be $2,802.  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 $30 million.   The reduced fee program does not apply to foreign, non USA firms.  There are some exemptions from fees.  Call for details.
Link to Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification