FDA Approval

510k. PMA. IDE.

Product approval of medical devices by the FDA is dependent on the FDA’s classification and product code for the device. A 510k application (premarket notification) is sufficient for class ll products. For class III (and some unclassified) products a PMA application (premarket approval) is required. In both processes, the manufacturer must demonstrate:

  • The products were developed and manufactured in compliance with GMP regulations (21 CFR 820)
  • The products meet the performance requirements defined by the FDA
  • Analyses of the efficacy and safety (validation) were performed. (For most class III submissions these data must be provided from clinical trials.)

 Our services include:

  • Advising on document preparation and requirements
  • Support in the creation or adaptation of documentation
  • Building an FDA compliant quality system
  • Creation of the 510(k) or PMA submission (on paper and eCopy format)
  • Submission to the FDA and support with FDA questions

 The Capamed Advantage:

  • Timely and competent completion of the approval process
  • Efficient preparation of your application and product documentation