🩺FDA Announces Regulatory Review Period for EDWARDS SAPIEN Device
Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's determination of the regulatory review period for the EDWARDS SAPIEN 3 device is crucial for businesses involved in patenting and marketing medical devices. Effective patent extensions can influence market strategy and revenue potentials, impacting financial planning and compliance obligations for affected businesses.