Tom Cowan

Knobbe Martens

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Latest Posts › 510(k) RTA

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Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?

The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in...more

12/6/2019 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications , Trademark Application , Trademark Registration , Trademarks , Use in Commerce , USPTO

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

9/18/2019 / 510(k) RTA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Pharmaceutical Industry , Premarket Approval Applications , Risk Assessment

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

8/15/2017 / 21st Century Cures Act , 510(k) RTA , Code of Federal Regulations (CFR) , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

8/11/2016 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Modification , Software

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