Tom Cowan on Food and Drug Administration (FDA)

Brain Computer Interface Developer Announces $33M Series A, Granted FDA “Breakthrough” Designation

Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA....more

5/30/2023 / Clinical Trials , Food and Drug Administration (FDA) , Health Technology , Medical Devices

USPTO Issues Notice Regarding Patent Examinations and FDA Submissions

On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug...more

8/5/2022 / Food and Drug Administration (FDA) , Intellectual Property Protection , Medical Devices , Patent Trial and Appeal Board , Patents , Pharmaceutical Industry , USPTO

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

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

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

11/7/2019 / Food and Drug Administration (FDA) , Intellectual Property Protection , Pharmaceutical Industry , Pharmaceutical Patents , 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

FDA Issues Draft Guidance for 3D Printed Medical Devices

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is...more

5/12/2016 / 3D Printing , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

FDA Announces 2016 Medical Device Fees

The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

8/20/2015 / Fee Reductions , Fees , Food and Drug Administration (FDA) , Medical Devices , Small Business

FDA Issues Guidances for Medical Device-Related Apps and Systems

The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more

3/9/2015 / Food and Drug Administration (FDA) , Healthcare , Medical Device Accessories , Medical Devices , Mobile Medical Applications , New Guidance

Tom Cowan

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