Medical Devices

We offer the following assistance to medical device manufacturers:
 
- Quality auditing and mock up inspection.
- Regulatory submissions.
- Medical Device Reporting Regulations (MDR).
- Pre-market Notification under 510(k) and Approval (PMA).
- Post Market surveillance.
- Quality System Regulations (QSR).
- Product Recall and Complaint Handling requirements.
- Form 483 and Regulatory Letter responses.
- Process and Sterilization Validations.
- FDA Registration and Listings.
- On-site training in FDA regulations.
- Assist with import issues.
- Act as your U.S. Agent.
  
Medical Device User Fees
 
Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), fees must be submitted to FDA before sending the 510(k) PMN or PMA submission to FDA. This fee is in addition to the fee charged by AP Consulting for 510(k) and PMA submissions. For fiscal year 2007 (October 1, 2006 through September 30, 2007), the fee for 510(k) review is $4,158 (or $3,326 for Small Business) and the fee for PMA is $281,600 (or $107,008 for Small Business). The Small Business fee does not apply to foreign firms. For more information, go to www.fda.gov/cdrh/mdufma

AP Consulting can act as the U.S. Agent for any non-U.S. medical device manufacturer. By law, a foreign company must have a U.S. Agent in the United States in order to import their products into the U.S. The responsibilities of the United States agent are:
 
- Assisting FDA in communications with the foreign establishments,
- Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States, and
- Assisting FDA in scheduling inspections of the foreign establishment.