FDA Announces 2016 Medical Device Fees
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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 Review reports that the new fees reflect an increase of greater than 4%.
The new fees will apply from October 1, 2015, through September 30, 2016. Some of the standard user fees for FY 2016, which are listed in the FDA notice as percentages of a full premarket application fee, are reportedly as follows:
- Pre-Market Application (PMA): $261,388
- Panel-track supplement: $196,041
- 180-day supplement: $39,208
- Real-time supplement: $18,297
- 510(k) premarket notification submission: $5,228
- 30-day notice: $4,182
- 513(g) request for classification information: $3,529
- Annual fee for periodic reporting on a class III device: $9,149
- Annual establishment registration fee: $3,845
Small businesses may pay reduced fees if they qualify before making their submission to the FDA. To qualify, businesses must file a FY 2016 Small Business Qualification and Certification request (as well as several other documents, including tax records). The establishment registration fee is not subject to reduction for small businesses; consequently, if that is the only fee a business anticipates paying in FY 2016, a Small Business Qualification and Certification request is unnecessary.
The FDA notice includes information on how the fees for FY 2016 were determined, the payment procedures that should be followed, and details regarding how businesses may qualify for reduced small business fees.
Tom is a Partner in the San Diego office and serves clients worldwide in aerospace, mechanical, and medical technologies. He counsels clients on overall IP strategy, performs IP audits, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies.
As a former aerospace engineer with experience at NASA and Northrop Grumman, and holding a master’s degree in biomedical engineering, Tom’s legal services are supplemented with his advanced technical abilities in a wide range of inventive domains.
Tom has particular experience with assisting startups from the conceptual design phase through acquisition. One recent example is Millipede, Inc., developer of a heart valve annuloplasty device. Tom prosecuted their patent portfolio and provided defensive patent diligence, resulting in investments and an acquisition by Boston Scientific totaling $540,000,000.
Other example particular technologies in Tom’s patent experience include cardiac devices, intracranial sensors, prosthetics, aircraft and rockets, robotics, unmanned aerial vehicles (drones), semiconductors, imaging and biosensors, high altitude balloons, control systems, thermal management systems, software, and more.
Additional highlights include:
Keynote Speaker, “Patent Basics for the Aerospace Industry,” at the 2019 Space Foundation Space Commerce Workshop
Former Mechanical engineer at Northrop Grumman, where he designed and tested complex structures and mechanisms for various spacecraft programs
Interned at NASA Armstrong Space Center, Aerodynamics Branch, where he analyzed data for the Quiet Supersonic Platform
Inventor of the “Inflate-A-Brake,” a system for de-orbiting small satellites to reduce space debris
Publications Coordinator for the firm’s medical device practice group, which leads the nation in medical device patent prosecution having obtained over 4,800 medical device patents since 1976 and 2,700 medical device patents since 2010
Member of the firm’s pro bono committee and coordinates with the U.S. Patent & Trademark Office’s regional patent pro bono program to assist indigent individuals and non-profit organizations
Co-Chair of the Licensing Executives Society (LES) for the San Diego Chapter
Holds a minor in Chinese and studied Chinese language and history at Shaanxi Normal University in Xian, China
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