The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance in manufacturing during, or in advance of, a declared public health emergency. On May 6, FDA’s Center for Devices and Radiological Health (CDRH) issued a direct-to-final guidance document addressing: (1) who must notify CDRH, (2) devices for which CDRH requires notification, (3) when to notify CDRH, (4) what information to include in the notification, and (5) how to notify CDRH. This guidance is intended to remain in effect only for the duration of the COVID-19 public health emergency.

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Photo of Wade Ackerman Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade…

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.

Photo of Scott Danzis Scott Danzis

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most…

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most complex regulatory challenges, including strategies for premarket review, postmarket compliance, and enforcement actions. Scott counsels many of the world’s preeminent medical device companies on a range of matters, including advertising and promotion, recalls, quality system issues, medical device reporting, clinical and non-clinical testing, FDA inspections, and other regulatory matters.

Scott previously served in FDA’s Office of the Chief Counsel where he served as the Special Assistant to the Chief Counsel of FDA. At FDA, Scott was involved in a wide range of legal and regulatory matters, including significant rulemaking, enforcement actions, and legislative initiatives.

Scott speaks regularly at conferences regarding FDA regulation of devices and diagnostics, and since 2010 serves as an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on FDA law.

Scott is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of Coif. He also holds a Master’s Degree from George Washington University and a Bachelor of Science from Cornell University.

From 2006 to 2008, Scott served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Scott has significant experience in the following areas:

  • FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices;
  • Appeals and dispute resolution within FDA;
  • IDEs, INDs, and clinical trial regulation;
  • Advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations;
  • Imports and exports of FDA regulated products;
  • QSR and cGMP requirements, including responding to FDA 483s and enforcement actions;
  • Product recalls;
  • Adverse event and MDR reporting;
  • FDA consent decrees and OIG corporate integrity agreements;
  • Regulatory due diligence;
  • Compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.

Scott recently developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center where he teaches a course on the regulation of drugs, biologics, and medical devices.

Scott clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.

Photo of Amy Leiser Amy Leiser

Amy Leiser assists medical device, clinical laboratory, pharmaceutical, and biotechnology clients to operate within a complex, highly regulated area in a way that supports achieving their business goals while minimizing regulatory and litigation risks.

With a focus on medical device, digital health, and…

Amy Leiser assists medical device, clinical laboratory, pharmaceutical, and biotechnology clients to operate within a complex, highly regulated area in a way that supports achieving their business goals while minimizing regulatory and litigation risks.

With a focus on medical device, digital health, and diagnostic products and laboratory services, Amy regularly advises clients on a variety of regulatory, legislative, and compliance matters, including under the Federal Food, Drug & Cosmetic Act (FDCA), Clinical Laboratory Improvement Amendments (CLIA), and state clinical laboratory laws.

In her work with both new and established companies, Amy regularly:

  • Counsels clients on development and marketing pathways for new products and services, including considerations relating to:     
    • The scope of FDA’s medical device jurisdiction as it relates to digital health tools and laboratory testing services;
    • Issues surrounding classification, clearance, and approval of new devices; and
    • Issues uniquely impacting combination products.
  • Assists clients in advocating for legislative and regulatory policies that will support innovation and access to diagnostics and therapeutic products, including by commenting on proposed legislation, rules, and guidance documents.
  • Advises clients on compliance with medical device postmarketing requirements, including reporting of medical device reports and corrections & removals.
  • Supports clients in responding to domestic and international enforcement actions, including:
    • Providing regulatory support for Department of Justice investigations;
    • Drafting responses to FDA warning letters and international regulatory enforcement letters; and
    • Advising on FDA 483 responses to manufacturing inspection observations.
  • Supports life science transactions by:
    • Evaluating regulatory compliance of companies; and
    • Advising on collaboration and commercial agreements, as well as quality agreements that support manufacturing and related services.

Amy has also supported the day-to-day legal operations of device clients through in-house secondments during periods of transition or particularly high demand on their legal resources.

Prior to joining Covington, Amy was an Associate Specialist in Engineering within the Merck Manufacturing Development Program at Merck & Co., where she supported vaccine manufacturing operations and clinical trial services.

Amy was named a Rising Star in Food and Drug Law by Washington DC Super Lawyers for 2019-2020 and by Northern California Super Lawyers for 2022-2024.