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Scott D. Danzis

Partner

Washington +1 202 662 5209 sdanzis@cov.com Download V-card

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Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses on the regulation of medical devices and diagnostics. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

From 2006 to 2008, Mr. Danzis 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.

Mr. Danzis 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.

Mr. Danzis 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.

Mr. Danzis 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.

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U.S. Food and Drug Administration, Office of the Chief Counsel
U.S. Department of Health and Human Services, Agency for Health Care Policy and Research

Opening the Doors: Return-to-Workplace Considerations During COVID-19

Businesses are developing plans for reopening workplaces. As they do, many employers are considering ways to determine which employees can safely return to the workplace, and what protective equipment should be provided to employees once they return. In both the United States and European Union, many of the products used in these strategies are regulated as ...

Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH

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 ...

FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH

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, ...

Food and drug regulatory specialists help turn vodka into sanitizer

Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests. Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the ...

COVID-19: Regulatory Considerations for Medical Device Companies

Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...

Test makers say testing volume ramping up quickly despite concerns over reagents

Scott Danzis spoke with BioWorld about the uptick in coronavirus testing by the FDA and CDC. Mr. Danzis says that while the FDA and the CDC struggled to move testing forward in the early days, “things have shifted dramatically” since that time. He adds that the issue of FDA regulation of lab-developed tests is of long standing, but that the Verifying ...

FDA turns to Twitter to help track testing supply shortages

Scott Danzis is quoted in Politico regarding tracking medical device shortages and whether regulations requiring drug manufacturers to warn the government when a shortage seems likely should be applied to medical devices. Mr. Danzis says, “There's a balance that has to be struck between giving that information to FDA and creating additional reporting ...

COVID-19: Legal and Business Toolkit

As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...

2019 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the ...

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ...

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial ...

2018 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2018 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality ...

2017 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...

FDA Outlines Updated Approach to Regulating Digital Health Technologies

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...

FDA Outlines Updated Approach to Regulating Digital Health Technologies

The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective

On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered ...

Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

Scott Danzis is quoted in a Regulatory Focus article regarding the allowance of third-party reviews under the FDA Reauthorization Act. “While the revised statute does allow for implantable, life sustaining, or life supporting devices to be eligible for third party review, we expect that FDA will be cautious in adding such devices to that program," Danzis says. ...

FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices

On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee ...

Life Sciences Group Of The Year: Covington & Burling

Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...

21st Century Cures Act: Key Provisions (Title III - Development)

On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on ...

Medical Device Reporting for Manufacturers; Final Guidance

On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...

Best Lawyers Names Covington’s Stuart Eizenstat and Gregg Levy Lawyers of the Year

WASHINGTON, DC, August 18, 2014 — Best Lawyers named Covington & Burling’s Stuart Eizenstat and Gregg Levy each a 2015 “Lawyer of the Year” in international trade and sports law, respectively, citing their “abilities, professionalism and integrity.” Overall, Covington lawyers received 217 individual mentions in 58 areas of law in the newly released annual survey ...

Covington Advises Illumina in Acquisition of Verinata Health

NEW YORK, January 7, 2013 — Covington & Burling advised Illumina, Inc. on its announced acquisition of Verinata Health, Inc. for cash consideration of $350 million plus up to $100 million in milestone payments through 2015. Upon completion of the acquisition, Illumina will have access to the Verinata’s verifi® prenatal test, the broadest non-invasive prenatal ...

Covington Receives 196 Individual Mentions in 2013 Edition of Best Lawyers

WASHINGTON, DC, August 27, 2012 — Covington & Burling LLP lawyers received 196 individual mentions in 57 areas of law in the 2013 edition of The Best Lawyers in America. This annual compilation of top U.S. lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as ...

Covington Advises Salix Pharmaceuticals in $300M Acquisition of Oceana Therapeutics

WASHINGTON, DC, November 10, 2011 — Covington & Burling represented Salix Pharmaceuticals, Ltd. in its agreement to acquire Oceana Therapeutics, Inc., a privately held global provider of gastroenterology and urology therapeutics, for $300 million in cash. “The acquisition of Oceana expands our product portfolio of innovative products, furthers the ...

Covington Receives 138 Individual Mentions in 2011 Edition of Best Lawyers

WASHINGTON, DC, August 6, 2010 — Covington & Burling LLP received 138 individual mentions in 40 areas of law in the 2011 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...

Covington Promotes 12 Lawyers to the Partnership

WASHINGTON, DC, October 1, 2008 — Covington & Burling LLP today announced that 12 of its lawyers have been elected to the firm’s partnership. These new partners are resident in four of the firm’s offices and practice in the litigation, corporate/tax, and regulatory fields. Timothy Hester, chair of the firm’s management committee, commented: “These young and ...

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Scott D. Danzis

Previous Experience

News and Insights (Showing 5 of 114) (Showing 114 of 114)

Accolades

COVID-19: Legal and Business Toolkit

Practices

Industries

Education

University of Virginia School of Law, J.D., 2000

The George Washington University, M.H.S.A., 1996

Cornell University, B.S., 1993

Government Service

Judicial Clerkship

Bar Admissions