Product Approval
Registration and listing

Before marketing a medical device or health product in the US, or reintroducing a device that has been modified affecting safety or effectiveness, manufacturers or parties of interest need to submit to the Food and Drug Administration FDA a pre market notification 510(k) and demonstrate by performance data and product documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced. In case there is no equivalente product cleared for marketing in the US, a premarket approval PMA submission might need to be followed. In those cases clinical or animal test data might need to be submitted.

Sigma Biomedical provides complete regulatory consulting services for Food and Drug Administration (FDA) 510(k) submissions, as well as for other medical regulatory affairs needs, such as FDA Quality System Regulations QSR compliance. Sigma's regulatory, engineering and scientific team can efficiently help you achieve FDA Substantially Equivalent notices.

Pre-Submission Services

Sigma Biomedical initially evaluates your product documentation to determine compliance with regulations. This will help prepare a complete 510(k) document thus optimizing the 510(k) review process. Services include:

  • Product analysis
  • Predicate finding
  • Product classification
  • GAP Analysis
  • Submission strategy definition

510(k) Submission Preparation

During this stage performance data is obtained for the 510(k) submission The FDA guidance for the specific product submission is followed to ensure compliance with regulations. Activities include:

  • Performance data is obtained
  • Predicate comparison
  • Product description writing
  • Labeling validation and optimization
  • 510(k) document preparation

510(k) Submission and Follow-up

Once the 510(k) document is compiled and thoroughly reviewed for completeness. the document is submitted to the FDA for review and approval process. Activities include:

  • Filing fee form registration
  • 510(k) submission
  • 510(k) follow-up with FDA officials
  • Responses to requests for additional information
  • Communication with sponsor