Do the developing changes to the requirements for 510(k) submissions or a revamping of the de novo automatic Class III designation process have you worried? Rest assured, we are tracking potential changes to these approval pathways closely, including the possible creation of II(b) device pathways, and can help your company successfully navigate evolving CRDH requirements. With our long history and substantial FDA Compliance expertise, we can assist manufacturers, distributors and importers with compliant product development strategies covering:
• Premarket Approval Applications (PMAs)
• Premarket Notifications (510(k)s)
• Investigational Device Exemptions (IDE)
• Quality System Regulation (QSR)
• Medical Device Reporting (MDR)
• FDA establishment inspections
• Import/export of medical devices
• FDA 483s and Warning Letters
• Recalls, injunctions and seizures
• Labeling, advertising, and promotion
• Establishment registration and medical
device listing requirements
Don’t let FDA compliance with complex government regulations or developing changes to the 510(k) clearance or de novo review processes throw your project off schedule and off-budget. Contact one of our medical device regulatory consultants experts today for an initial consultation.
Cynthia Ipach – Drug & Medical Devices Consultant
Compliance Insight
497 Circle Freeway Drive, Suite 230, Cincinnati, Ohio, 45246