🏥FDA Notice on Patent Extension for DIAMONDBACK 360 Device
Determination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document involves regulatory requirements for the patent extension of a medical device, impacting business owners in the healthcare industry by determining their patent protections and market exclusivity. Businesses involved in medical devices must comply with FDA regulations and potentially navigate financial liabilities associated with patent expiration.