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Covington acts as regulatory counsel to device and diagnostics companies ranging from start-up ventures to multinational manufacturers, clinical laboratories, and industry trade associations. We advise on the full range of regulatory requirements and strategies for the entire product lifecycle. Through our offices in the US, Europe and Asia, and strategic alliances in other key jurisdictions, Covington effectively advises device and diagnostic clients on a global basis. Our team includes lawyers with experience at FDA.
Covington has extensive, global experience advising device and diagnostic clients with respect to the full range of regulatory matters—presubmission strategy, clinical trials, marketing authorizations, supervisory review and dispute resolution proceedings, manufacturing and quality systems compliance, postmarket reporting, and advertising and promotion. Our lawyers worldwide work seamlessly to deliver comprehensive and insightful advice and representation with national and regional expertise.
We have experience with a wide range of medical devices. We advise on evolving FDA policies regarding mobile apps, companion diagnostics, radiological imaging products, and laboratory developed tests (LDTs). Our knowledge of the Federal Food, Drug, and Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), state laws, and FDA regulatory policy allows us to provide strategic insight to our clients.
We also handle issues involving combination products, and advise pharmaceutical and biotechnology companies regarding medical device requirements relevant to their pharmaceutical products and strategic partnerships.
We conduct regulatory due diligence in connection with mergers, acquisitions, and IPOs, including review of premarket notifications (510(k)s), premarket approval applications (PMAs), investigational device exemptions (IDEs), and other FDA regulatory files. Our due diligence frequently includes postmarket requirements, including adverse event reporting, sales and marketing compliance, compliance with FDA’s quality system regulation, and an array of other issues.
We also advise clients on many types of enforcement matters, including responding to notices of inspectional observations and warning letters, product seizures, recalls, injunctions, civil penalties, and criminal proceedings. We have negotiated consent decrees and voluntary agreements arising out of medical device quality systems, manufacturing practices, and promotion issues.
We have been involved with all of the major legislative initiatives that have affected medical device regulation since the Medical Device Amendments of 1976, including the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the Food and Drug Administration Amendments Act of 2007, the Medical Device User Fee and Modernization Act, the Food and Drug Administration Modernization Act of 1997, and the Safe Medical Device Act of 1990.
Our European team advises clients on current and proposed device regulatory requirements in the European Union, including the proposed changes to the device regulatory framework. We review regulatory documents such as certifications or registrations, and the underlying technical documentation, facility permits, and inspection reports, both from self-audits or those by third parties, such as inspections by notified bodies and European health authorities. We also advise on safety notifications and compliance matters.
Our China team, including members in Beijing and Shanghai, advises companies on the regulatory requirements of the China FDA and provincial FDA authorities regarding clinical trials, premarket review and approval, manufacturing practices, import requirements, and postmarket compliance matters. The team is led by the managing director of our Asia food, drug and device practice, who has over 10 years of experience in this field.
Advise large device company on regulatory requirements for clinical trials of medical devices in China.
Assist medical device manufacturer with drafting of standard operating procedures (SOPs) and guidelines for the creation, review, and use of promotional materials.
Comprehensive review of internet and social media promotion for a leading multinational medical device company.
Review of device sales and marketing compliance policies in accordance with a Corporate Integrity Agreement.
Advocacy before Congress, FDA, and other federal agencies with respect to emerging regulatory policies on health information technology, research use products, and laboratory developed tests.
Conducting due diligence on China device regulatory matters for a large multinational device company’s acquisition of a large Chinese device company.
Advising distributors of prescription drugs and medical devices concerning compliance with the Food, Drug, and Cosmetic Act, FTC Act, and Lanham Act advertising standards.
Representing Schering-Plough (now Merck) in multi-district class action litigation challenging so-called reverse payment settlements of pharmaceutical patent litigation. Obtained denial of certification of indirect purchaser class, after which indirect purchasers voluntarily dismissed their case. The team previously defeated the FTC at trial in an action on the same facts, and will now have the opportunity to resolve the direct purchaser portion of the case under a recent Supreme Court decision.
Representation of companies and individuals in negotiation of GMP consent decrees involving drugs, biologics, devices, and blood products, including significant consent decree matters for Schering Plough, Genzyme and one of the largest manufacturers of OTC drugs in the U.S.
Illumina in a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes.
Conducting due diligence investigations and performing risk assessments to evaluate potential product or toxic tort liabilities associated with pharmaceutical and medical device companies bringing products to market.
Representation of industry stakeholders in negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
Advise multinational company on regulation of online information on drugs, devices, and food products in China.
Representation of Merck in its $41 billion merger with Schering-Plough.
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
January 15, 2017, Inside Medical Devices
In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping. The 2016 warning letters inform current … ...
January 7, 2017, Inside Medical Devices
On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.” In a separate post, we reported on the January 22, 2016 draft version of this guidance document. The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and ...
January 3, 2017, Inside Medical Devices
The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be … ...
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 19, 2016, Inside Medical Devices
The European Commission is expected to present, in early 2017, a proposal to amend the RoHS2 Directive. The amendment would remove the July 22, 2019 deadline for the supply and resale of non-compliant electronic medical devices, in-vitro diagnostic medical devices (IVDs) and monitoring and control instruments that were first marketed in, or imported into, the … ...
December 12, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of ...
December 6, 2016, Covignton 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, ...
November 20, 2016, Inside Medical Devices
On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014. … Continue ...
November 18, 2016, Inside Medical Devices
It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key … Continue Reading
November 15, 2016, Inside Medical Devices
The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what … Continue Reading
November 13, 2016, Inside Medical Devices
On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”). The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the ...
October 31, 2016, Inside Medical Devices
On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program. The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to ...
October 6, 2016, Inside Medical Devices
The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health. The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity … Continue ...
October 2016, Digital Health Legal
September 30, 2016, Inside Medical Devices
As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and … Continue ...
September 22, 2016
WASHINGTON—Pamela Forrest has joined Covington in its Food, Drug, and Device practice, resident in Washington.
Ms. Forrest has more than 20 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket review, product recalls, medical device reporting (MDR), Quality System ...
September 19, 2016, Inside Medical Devices
Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential ...
September 16, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules). These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National ...
September 16, 2016, Covington Alert
On September 12 and 13, 2016, the U.S. Food and Drug Administration (FDA) held a two-day public hearing to obtain input on four draft guidance documents issued by the agency concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).
September 9, 2016, Inside Medical Devices
On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16). The qualification of ...
September 2, 2016, Inside Medical Devices
Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about ...
August 31, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules). This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which ...
August 31, 2016
LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles.
Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...
August 5, 2016, Inside Medical Devices
Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.” This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and ...
In a new post on the Covington eHealth blog, our colleagues provide an analysis of the European Commission’s updated guidance on when medical software will be deemed to be a medical device under EU law. To read the post, please click here.… Continue Reading
August 4, 2016, Inside Medical Devices
On July 29, 2016, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2017, which applies from October 1, 2016 through September 30, 2017. The FY 2017 user fees declined from the previous year’s rates. Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended by the … Continue Reading
August 2, 2016, Inside Medical Devices
FDA recently published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” A companion diagnostic is an in vitro diagnostic device that provides “information that is essential for the safe and effective use of a corresponding therapeutic product.” The new draft guidance is ...
July 15, 2016, Covington Alert
Yesterday, the United States House of Representatives passed Bill S.764 (“Joint Bill”), which will amend the Agricultural Marketing Act of 1946 to add Subtitle E: “National Bioengineered Food Disclosure Standard,” and Subtitle F: “Labeling of Certain Food.” The United States Senate passed the same bill last week on July 7, 2016. The Joint Bill, if signed into ...
July 12, 2016, Inside Medical Devices
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU … Continue Reading
July 11, 2016, Covington Alert
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...
June 30, 2016, Inside Medical Devices
On June 7, 2016, the China Food and Drug Administration (“CFDA”) released the Notice on Regulating Distribution Activities in Medical Device Circulation (“Notice”). The Notice requires that distributors of Class II and III devices assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of ...
June 8, 2016, Inside Medical Devices
On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”). Comments are due on June 20, 2016. This is the second round of clinical trial exemption catalogues since the revisions to … Continue Reading
May 20, 2016, Inside Medical Devices
The European Commission is preparing its first borderline decision under Article 13(1)d of Medical Devices Directive 93/42 (“the Article 13 Decision”). The draft is available here. This provision allows Member States to request that the European Commission decide whether a specific product should be considered a medical device. The draft Article 13 Decision ...
May 12, 2016, Inside Medical Devices
Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners. As it sets a new course, France is now at the European forefront of ...
May 7, 2016, Inside Medical Devices
The China Food and Drug Administration (“CFDA”) and National Health and Family Planning Commission of China (“NHFPC”) have jointly released a revised and substantially expanded set of Good Clinical Practices for Medical Device Clinical Trials (“New Device GCP”), which will go into effect on June 1, 2016. The New Device GCP are an important piece … Continue ...
December 21, 2015, Inside Medical Devices
Following a significant revision of its framework medical device regulation (see our alert, here), the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), ...
September 14, 2015, Covington Alert
August 11, 2015, Covington Alert
7/30/2015, Covington Alert
April 21, 2015, InsideMedicalDevices Blog
April 20, 2015, Inside Medical Devices
The China Food and Drug Administration (CFDA) has revised its good manufacturing practices (GMPs) for medical devices and taken steps to increase enforcement. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China. Under the recently revised framework regulation for medical ...
February 18, 2015, Inside Medical Devices
As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST). Our panelists, including two alumni of the FDA Office of Chief Counsel, will address: What factors determine whether an eHealth product is considered a medical device ...
January 27, 2015, Scrip Regulatory Affairs
January 20, 2015, InsideMedicalDevices Blog
January 12, 2015, InsideMedicalDevices Blog
December 2014, eHealth Law & Policy
November 14, 2014, Law360
October 10, 2014, InsideMedicalDevices Blog
September 2, 2014, Covington E-Alert
August 21, 2014, InsideMedicalDevices Blog
August 5, 2014, Covington E-Alert
July 1, 2014, InsideMedicalDevices Blog
June 2, 2014, InsideMedicalDevices Blog
May 22, 2014, InsideMedicalDevices Blog
April 30, 2014, Covington E-Alert
April 25, 2014, Covington E-Alert
April 9, 2014, Covington E-Alert
February 28, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
January 16, 2014, Covington E-Alert
January 10, 2014, Covington E-Alert
December 31, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
October 1, 2013, Covington E-Alert
September 25, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
August 19, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
August 2013, Journal of Medical Device Regulation
July 31, 2013, Covington E-Alert
July 30, 2013, Covington E-Alert
June 27, 2013, Covington E-Alert
June 20, 2013
LONDON, 20 June, 2013 — Covington & Burling acted for Canaccord Genuity Limited (nominated adviser and joint broker) and WG Partners, a trading name of Charles Stanley & Co. Ltd (joint broker), to AIM-quoted Lombard Medical Technologies plc on its placing and subscription of ordinary shares to raise approximately £22 million before expenses.
Lombard is a ...
June 13, 2013, InsideMedicalDevices Blog
May 30, 2013, Covington E-Alert
April 26, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
April 9, 2013, Covington E-Alert
March 28, 2013, Covington E-Alert
March 25, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
Winter/Spring 2013, The SciTech Lawyer
February 27, 2013, Covington E-Alert
February 13, 2013, Covington E-Alert
February 1, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
December 28, 2012, Covington E-Alert
December 7, 2012, Covington E-Alert
December 3, 2012, Covington E-Alert
October 31, 2012, Covington E-Alert
October 3, 2012, Covington E-Alert
September 28, 2012, Covington E-Alert
September 26, 2012, Covington E-Alert
September 2012, European Pharmaceutical Contractor
August 31, 2012, Covington E-Alert
August 2012, Journal of Medical Device Regulation
July 26, 2012, Covington E-Alert
July 16, 2012, Covington Advisory
June 11, 2012
WASHINGTON, DC, June 11, 2012 — Chambers USA recognized 106 individual Covington & Burling lawyers and 46 Covington practice areas in the 2012 Chambers USA: America’s Leading Lawyers for Business guidebook released on June 7, 2012.
Many of the 106 Covington lawyers ranked by Chambers USA were recognized in multiple categories, resulting in a total of 131 ...
June 11, 2012, Covington E-Alert
June 7, 2012, Covington Advisory
May 29, 2012, Covington E-Alert
May 8, 2012, Covington E-Alert
April 30, 2012, Covington E-Alert
March 23, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
March 12, 2012
WASHINGTON, DC, March 12, 2012 — Covington & Burling LLP has applied to open a new office in Seoul and tapped William H.Y. Park, a veteran corporate lawyer based in Korea, to help oversee the expansion.
Mr. Park will work closely with former Ambassador to the United Nations Daniel Spiegel, senior of counsel at Covington, who will be the Foreign Legal Consultant ...
February 29, 2012, Covington E-Alert
February 13, 2012, Covington E-Alert
February 7, 2012, Covington E-Alert
November 9, 2011, Educational Program for Chinese SFDA Officials, New Haven, CT
August 15, 2011
WASHINGTON, DC, August 15, 2011 — Covington & Burling LLP is pleased to announce that Ellen Flannery has been appointed to the American Bar Association Standing Committee on the Federal Judiciary.
Ms. Flannery is co-chair of the firm’s food and drug law practice group. She will serve a three-year term as the Federal Circuit member of the committee. At the ...
August 4, 2011, Covington E-Alert
June 13, 2011, Covington E-Alert
April 15, 2011, Covington E-Alert
November 2010, Journal of Medical Device Regulation
August 10, 2010, Covington E-Alert
June 21, 2010, Covington E-Alert
April 29, 2010, Covington E-Alert
January 15, 2010
LONDON, January 15, 2010 — Covington & Burling LLP advised Minster Pharmaceuticals plc, the AIM-quoted drug development company specialising in compounds for the treatment of neurological and psychiatric conditions, in its recommended takeover by Proximagen Neuroscience plc. The terms of the all cash offer value Minster at £4.3 million. The Covington team ...
April 13, 2009, Covington E-Alert
April 2, 2009, Covington E-Alert
March 6, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
January 26, 2009, Covington E-Alert
January 21, 2009, Covington E-Alert
January 16, 2009, Covington E-Alert
December 23, 2008, Covington E-Alert
October 2008, EURALex
September 2008, Covington E-Alert
March 2008, Covington E-Alert
February 19, 2008, Covington E-Alert
October 2, 2007, Covington E-Alert
May 3, 2007, Covington E-Alert
January 19, 2007, Covington E-Alert