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, Humphrey Regulatory Consulting (HRC) is 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 expertise, HRC can assist manufacturers, distributors and importers with compliant product development strategies covering:
• Premarket Approval Applications (PMAs)
Don't let 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 experts today for an initial consultation.