Regulatory

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Regulatory

Forward thinking program design with regulatory considerations

Accelerant works with small and large companies ranging from those who seek direction at the earliest stages of formulating regulatory paths to those who require assistance refining near-complete regulatory filings. Our services include:

  • FDA interface and preparation for Pre-IDE meetings(DES) and other applicable communications.
  • FDA submissions, including Investigational Device Exemptions (IDEs), 510(k)s, Humanitarian Device Exemptions (HDEs) and Premarket Approvals (PMAs).
  • International filings including Canadian Medical Devices Regulations,Japanese Shonin, Australian TGA, CFDA and others International product submissions including Design Dossiers/Technical Files for CE Marking and individual country submissions Product labeling including Instructions for Use, patient brochures and User Manuals State of California and FDA Quality System inspection support.