Medical Device Submissions Series: 510(k) & De Novo Workshop

Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).

Jemin Dedania assists clients with regulatory and policy issues, with a focus on U.S. Food and Drug Administration (FDA) medical device and combination product strategies. He advises medical technology companies on matters related to life cycle management, promotional issues, and compliance, and provides general advice on navigating FDA’s regulatory framework.  

Jemin has worked with combination products and medical devices since completing his master’s thesis in biomedical engineering, in which he focused on novel growth factor technologies in bone healing. Upon graduating from the New Jersey Institute of Technology, he was a lead reviewer, and later a team lead, at FDA’s Center for Devices and Radiological Health in the Division of Orthopedic Devices (now the Office of Health Technology 6) for nearly eight years. He then transitioned to Stryker, where he served as a specialist and later manager in the Regulatory Affairs department. At Stryker, Jemin developed regulatory strategies for new product development projects, authored regulatory submissions, provided guidance on novel combination product submissions, interfaced with notified bodies, led advertising and promotion reviews, supported mergers and acquisition due diligence and integration efforts, and developed his staff. 

Melissa Hall is a seasoned regulatory affairs professional with over 12 years of experience specializing in U.S. Food and Drug Administration (FDA) regulation of medical devices. A former FDA reviewer, manager, policy analyst, and industry educator, she brings a deep, insider understanding of FDA expectations, regulatory pathways, and review dynamics. 

In her current role as a regulatory consultant and strategic advisor, Melissa supports medical device companies in developing and executing effective regulatory strategies, preparing high-quality submissions, and engaging in clear, productive communication with the FDA. She is particularly valued for her ability to translate complex regulatory requirements into practical, risk-based solutions that facilitate efficient review and market access.

Ginny leads the RA team for digital health regulatory affairs efforts for software based products and solutions at Dexcom, including US/OUS software, data platform, APIs and data product regulatory classification, registration/approval and sustaining. Ginny’s RA team also manages partnerships and cybersecurity regulatory efforts. Her team continues to support all regulatory activities, including US/OUS regulatory pathway, breakthrough device designation, IDE, Q-subs and 510(k) submissions associated with Dexcom’s New Market initiatives.

Sally Maher is the founder of the consulting group S Maher Consulting, a premier medical device consulting organization. Ms. Maher served on the Board of Directors for ACell Inc. Previously she served as the interim Chief Operating Officer for ACell Inc. Before that she was Vice President of Regulatory and Clinical Affairs at Edwards Lifesciences, Critical Care. She has more than 30 years of medical device and combination product experience in regulatory, clinical, reimbursement, healthcare compliance, and product development. 

Jessica Ringel advises medical device and other life sciences manufacturers and distributors on matters spanning the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans. 

Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.  She further assists life sciences firms with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program.    

Prior to joining FDA/CDRH in 2008, he worked for ~20 years in the medical device industry, serving in engineering and leadership roles with a focus on managing teams that served as the clinical and technical interface between the company and healthcare providers.  He has extensive experience designing and testing devices, conducting animal studies, conducting IDE and international clinical trials, preparing regulatory submissions, negotiating with FDA, and launching products for marketing and sales in U.S. and international markets. 

Ken Skodacek has been working with medical devices for over 30 years and serves as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH).  In this role, Ken provides a confidential, independent, and impartial resource that informally investigates complaints and resolves disputes.  He typically prevents and resolves misunderstandings through candid conversations and facilitated meetings with external stakeholders and FDA staff. The CDRH Ombudsman Program also ensures fair and efficient processing of appeals of CDRH decisions. Outside of his responsibilities at FDA, he has served as the Co-Chair of the American Bar Association’s Ombuds Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association. 

He previously served in the Center’s Clinical Trials Program, where he led the development and implementation of policies and programs intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process.  He represented the CDRH Innovation Team as a founding member of the Center’s Payor Communications Task Force, which provides opportunities to improve patient access to innovative medical devices important to public health by engaging manufacturers, payors, and healthcare technology assessment organizations.  He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement. 

Peter Yang currently serves as the program lead for the De Novo Program within the Office of Regulatory Programs, Office of Product Evaluation and Quality at the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). As the De Novo Program Lead, he oversees the program and provides scientific and regulatory oversight for all De Novo requests across the Center. Before becoming the program lead, Peter was a policy analyst within the De Novo Program for four years. He started his FDA career first as an ORISE postdoc and then as a medical device reviewer in the Division of Surgical Devices.

Peter’s background is in bioengineering – specifically tissue engineering and regenerative medicine, and more specifically tendon/ligament tissue engineering. He obtained his PhD from Georgia Tech in 2011.