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 withAdvaMed®. 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.    

Ken Skodacek has served as the Deputy Ombudsman for nearly 8 years with the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). He provides a confidential, independent, and impartial resource for preventing conflicts and resolving scientific and regulatory disputes, both with and within CDRH.  He also ensures fair and efficient processing of formal appeals consistent with statutory and regulatory requirements.  

He is the co-curator of a course “for the ombuds curious” on Coursera — Ombudsman: A Unique Role in Dispute Resolution. The course offers a global overview of the many ombuds roles and models, how they function, the values they share, and how they support individuals, organizations, and governments across sectors and countries. It features diverse and personal perspectives from almost 150 practitioners and highlights the role of ombuds in a variety of contexts. 

He first learned about COFO on October 11, 2018 – at the inaugural Ombuds Day event in Washington DC – and then attended his first COFO annual conference on the following day. The next year, he coordinated the 2^nd annual Ombuds Day event, served as the COFO Liaison for Ombuds Day activities, and supported planning for COFO annual conference to “pay it forward” to other new ombuds.  He has benefited from the COFO Mentoring Program as a mentee and has served as a mentor for the program.  He supported the COFO Social Media Committee, which maintains a LinkedIn group for COFO. Separate from COFO, he has served as Co-Chair of the American Bar Association’s Ombuds Committee as well as Chair of the Ombuds Day Subcommittee.  He is an active member of the United States Ombudsman Association, the American Bar Association’s Section of Dispute Resolution, and the Interagency Dispute Resolution Working Group.  He established and maintains the Ombuds Day webpage and has been active in planning Ombuds Day related initiatives, including event programming and the Ombuds Day Proclamation Request-a-Thon every year since 2019.   

Prior to his current role, he has led and supported multiple new initiatives within CDRH, with a focus on fulfilling strategic priorities for the organization to promote and protect the public health. He is also a founding member of the Center’s Payor Communications Task Force, which provided opportunities to improve patient access to innovative medical devices important to public health facilitating collaboration between manufacturers, payors, and healthcare technology assessment organizations. He has also led numerous training initiatives within the agency, including the Reviewer Certification Program and coursework on conflict resolution for new leaders.  

Outside of his work at FDA, he supported the Health and Human Services (HHS) Innovation, Design, Entrepreneurship, and Action (IDEA) Lab for multiple years, serving as a coach and co-facilitator for the HHS Ignite Accelerator, which trained and supported staff developing and testing ideas to address difficult challenges.  Some of his work was captured in Design Thinking for the Greater Good: Innovation in the Social Sector. He has received formal training in professional coaching, human-centered design, and mediation.  

Before joining the federal sector, he worked for nearly 20 years as a biomedical and electrical engineer in the medical device industry. He held several leadership roles, focusing on the technical and clinical interface between companies, healthcare providers, and patients. His expertise spans the entire product lifecycle, from the initial design concept to successful product launches in both U.S. and international markets. 

Find and follow him on LinkedIn. 

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.