FDA Consulting Services:

Regulatory Services

We offer expertise with regards to compliance, Quality Assurance/Quality Assistance, Operational & Compliance Audits, IDE, 510 (k), PMA and IDE.

Providing assistance in regulatory services for filing of the following:

• 510(k)
  • Premarket submission made to the FDA
  • Demonstrates device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PM
  • Hyperlink to “About the 510(k) applications to the FDA”
• PMA
  • PMA is “The process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices”
  • PMA is the “most stringent type of device marketing  application required by the FDA”
  • PMA must be FDA approved prior to marketing the device
  • FDA has 180 days to review PMA
• IDE
  • An IDE (Investigational Device Exemption) allows use in a clinical study in order to collect effectiveness and safety data
  • Safety and effectiveness data is required to support a Premarket Approval (PMA) or a Premarket Notification [510(k)]
  • Clinical studies are most often conducted to support a PMA