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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.
Previous Experience
- 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
March 2021
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 ...
March 9, 2021, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In February, the Office of Prescription Drug Promotion (OPDP) posted the following warning letters on FDA’s website[1]: ...
HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration
February 2, 2021, Covington Alert
On January 15, the final Friday of the Trump administration, the Department of Health and Human Services (“HHS”) published in the Federal Register a notice permanently exempting or proposing to exempt 101 medical devices that previously required a premarket clearance under section 510(k) of the Food, Drug & Cosmetic Act (“FDCA”). Under the notice, seven class I ...
January 26, 2021, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2020 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 ...
Covington's London Public Company Practice Closes a Strong Year of Life Sciences Transactions
January 25, 2021
LONDON–Covington’s London corporate team has advised AIM- and Main Market-listed clients on multiple fundraisings and acquisitions over the past few months, marking a strong year in life sciences transactions. These include: Advising Sensyne Health plc, a UK clinical AI company listed on the London AIM market, on its £27.5 million equity fundraising The ...
January 25, 2021
LONDON—Covington advised Nasdaq-listed Oxford Immunotec Global PLC in its agreement to be acquired by PerkinElmer, Inc., in a deal valued at approximately $591 million. Under the terms of the acquisition, Oxford Immunotec shareholders will be entitled to receive $22.00 in cash for each outstanding ordinary share. The terms of the acquisition value Oxford ...
January 6, 2021, MedTech Insight
Scott Danzis is quoted in MedTech Insight regarding the FDA’s final guidance on its new Safer Technologies Program for Medical Devices (STeP) program, which is intended to provide additional support to developers of medical devices that significantly improve on existing products. Mr. Danzis says that STeP is a "welcome complement" to the FDA's Breakthrough ...
December 10, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In November, the Office of Prescription Drug Promotion (OPDP) posted the following untitled letter on FDA’s website: ...
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
October 28, 2020, Covington Alert
The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...
October 12, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In September, the Office of Prescription Drug Promotion (OPDP) posted three warning letters on FDA’s website, including ...
September 11, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
August 27, 2020, Medtech Insight
Scott Danzis spoke with Medtech Insight about a Department of Health and Human Services announcement stripping the FDA of its oversight over Laboratory Developed Tests, or LDTs. Mr. Danzis says, “By the terms of the policy that was issued, it is not restricted to COVID-19 LDTs. It is broader than that. Moreover, we’ve had recent discussions with senior HHS ...
August 25, 2020, Covington Alert
On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). Under this policy, HHS has determined that the Food and Drug Administration (FDA) must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. Depending on the next steps from HHS and FDA, this ...
August 18, 2020, Covington Digital Health
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software. The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which ...
June 10, 2020, Covington Alert
The COVID-19 pandemic is accelerating the digital transition and the adoption of artificial intelligence (“AI”) tools and Internet of Things (“IoT”) devices in many areas of society. While there has been significant focus on leveraging this technology to fight the pandemic, the technology also will have broader and longer-term benefits. As the New York Times has ...
May 18, 2020, Covington Alert
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 ...
May 15, 2020, Covington Digital Health
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 ...
May 14, 2020, Covington Alert
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, ...
April 23, 2020, Daily Journal
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 ...
April 1, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
March 29, 2020, Covington Alert
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 ...
March 19, 2020, BioTech
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 ...
March 18, 2020, Politico
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 ...
February 24, 2020, Covington Alert
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 ...
November 25, 2019, Westlaw Journal Medical Devices
October 17, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
October 8, 2019, Covington Digital Health
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 ...
May 2019, Journal of Medical Device Regulation
April 10, 2019, Covington Digital Health
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 ...
March 14, 2019, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 31, 2019, Covington Alert
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 ...
September 19, 2018, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 26, 2018, Covington Alert
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 ...
December 21, 2017, Covington Digital Health
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 ...
December 20, 2017, Covington Alert
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 ...
December 19, 2017, Covington Digital Health
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 ...
November 2017, Journal of Medical Device Regulation
October 10, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses
September 29, 2017, Regulatory Focus
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. ...
September 20, 2017, Covington Alert
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
February 10, 2017, Law360
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 ...
Device and Health Software Provisions
January 25, 2017, 21st Century Cures Act Webinar Series
January 17, 2017, Covington Alert
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 ...
December 22, 2016, Covington Alert
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 ...
December 6, 2016, Covington Alert
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, ...
Regulation of Diagnostics: Trends and Developments
September 29, 2016, BIO IP & Diagnostics Symposium
Regulation of eHealth Products and Mobile Apps
February 25, 2015, Covington’s Life Sciences Essentials Webinar Series
February 4, 2015, Covington E-Alert
January 26, 2015, Covington E-Alert
September 2, 2014, Covington E-Alert
August 21, 2014, Covington E-Alert
August 18, 2014, Covington E-Alert
August 18, 2014
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 ...
August 5, 2014, Covington E-Alert
July 2, 2014, Covington E-Alert
June 19, 2014, Covington E-Alert
April 30, 2014, Covington E-Alert
April 30, 2014, Covington E-Alert
April 1, 2014, Covington E-Alert
February 28, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 10, 2014, Covington E-Alert
December 2, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
October 1, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
July 31, 2013, Covington E-Alert
June 27, 2013, Covington E-Alert
May 30, 2013, Covington E-Alert
D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"
April 26, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
March 28, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
Winter/Spring 2013, The SciTech Lawyer
February 27, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
January 7, 2013
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 ...
December 28, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
October 31, 2012, Covington E-Alert
September 28, 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
August 27, 2012
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 ...
August 10, 2012, Covington E-Alert
July 26, 2012, Covington E-Alert
FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices
July 16, 2012, Covington Advisory
June 11, 2012, Covington E-Alert
June 7, 2012, Covington Advisory
May 29, 2012, Covington E-Alert
April 30, 2012, Covington E-Alert
April 24, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
February 29, 2012, Covington E-Alert
January 19, 2012, Covington E-Alert
January 9, 2012, Covington E-Alert
November 10, 2011
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 ...
November 2011, Journal of Medical Device Regulation
June 13, 2011, Covington E-Alert
November 2010, Journal of Medical Device Regulation
August 10, 2010, Covington E-Alert
August 6, 2010
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: ...
August 2010, Journal of Medical Device Regulation
June 21, 2010, Covington E-Alert
June 3, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
Jan 28th, 2010, Covington E-Alert
October 6, 2009, Covington E-Alert
April 29, 2009, Covington E-Alert
April 13, 2009, Covington E-Alert
March 20, 2009, Covington E-Alert
March 9, 2009, Covington E-Alert
December 23, 2008, Covington E-Alert
Government Affairs Practice Group Post Election Analysis
November 7, 2008, Covington Report
Covington Promotes 12 Lawyers to the Partnership
10/1/2008
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 ...
July 29, 2008, Covington E-Alert
January 27, 2006, Covington E-Alert
December 2004, Covington E-Alert
The New Drug Approval Requirement
April 29, 2004, Food & Drug Institute, Introduction to Law and Regulation
Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
December 8, 2003, Covington Report
- The Best Lawyers in America, FDA (2011-2018)
- Legal 500 US, M&A: Commercial Deals and Contracts (2016-2017)
- Washington DC Super Lawyers, FDA (2013-2017)
COVID-19: Legal and Business Toolkit
We are helping clients around the world navigate this evolving, complex situation.