Effective communication with regulatory agencies throughout the clearance and approval process of a medical device continues to be a core challenge for regulatory affairs executives. Crafting a solid relationship with regulatory bodies is vital to the success of not only 510(k) but PMA, de novo, IDE, Pre-Sub meetings and all other product submission avenues. By creating a culture within an organization to embrace regulatory interactions and utilize reviewer feedback, regulatory teams will be at the forefront of providing innovative medical devices for patient care faster and more efficiently. Also hear from a leading Division within CDRH how they are taking seriously the task of improving communications and working with industry on device submissions.
- -Successful regulatory interacton techniques
- -Managing inconsistent reviewer feedback
- -Forging a culture of communication within an organization
- -How a CDRH Division is addressing this challenge from its side of the equation