🦴FDA Patent Extension for TOTAL POSTERIOR SPINE SYSTEM
Determination of Regulatory Review Period for Purposes of Patent Extension; [TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM)]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM) 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 a patent which claims that medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's determination on the regulatory review period for the TOTAL POSTERIOR SPINE SYSTEM has significant implications for businesses in the medical device industry. It affects patent extensions that can enhance competitive market positioning, potentially influencing pricing strategies and market entry for new devices. Companies must prepare for compliance with the regulatory timeline and monitor for potential petitions.