Paul S. Gadiock
Paul Gadiock is a senior attorney in the Food, Drug, Medical Device & Agriculture group where he provides premarket and postmarket regulatory solutions on a variety of subject matters for medical device clients. As a former policy director at FDA and business development leader at a national biotechnology company, Paul brings unique first-hand experience with the development and application of regulatory programs to counsel clients at all stages of the medical product life cycle. Paul’s practice primarily focuses on representing medical device companies, small and large alike, in efficiently navigating local and national regulatory requirements.
Paul advises companies on a broad range of legal and regulatory issues, including:
- Determining regulatory requirements and least burdensome pathways for a mobile app developer to efficiently bring a device to market.
- Generating business-specific SOPs that comply with Quality System Regulations to promote business agility.
- Reviewing advertising material to ensure compliance with regulations while continuing to effectively promote capabilities to meet business needs.
- Creating comprehensive proposals aimed at influencing regulatory policy of specific medical products to decrease burden.
- Advising on relevant UDI requirements to fulfill high-visibility industry obligations and manage regulatory risk.
- Contacting client competitors to raise objections with company conduct and maintain competitive advantage.
- Determining and documenting the applicability of section 361 to biologic products.
- Conducting due diligence reviews to inform clients of risk when considering mergers or acquisitions.
Immediately prior to joining Arent Fox, Paul served as the Associate Center Director for Policy in the FDA’s Center for Devices and Radiological Health where he advised key agency officials on issues related to the application of policies, programs, regulations, and legislation. He was instrumental in appropriately encompassing or excluding devices from the scope of medical product regulation. Paul also minimized legal risk in GAO and OIG investigations, major national programs such as Unique Device Identification, and medical device cybersecurity as well as specific matters involving petitions and appeals to the FDA. He conducted numerous presentations and trained staff on how to streamline complex processes to reduce costs.
Before his senior leadership role within FDA, Paul served as a Business Development Executive for a national diagnostic biotechnology company. He advised international directors on how the company could comply efficiently, leading to cost-effective development of products that could be marketed in multiple countries with different regulatory requirements. Paul united scientists and sales teams to develop an extensive strategy that enhanced the company’s image and visibility by launching aggressive marketing campaigns.
ABOUT ARENT FOX LLP
Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.