Krista Carver

Krista Carver

Krista Hessler Carver advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters. Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products, and personalized medicine.

Subscribe to all posts by Krista Carver

Upcoming Webinar: Regulation of eHealth Products and Mobile Apps (February 25, 2015)

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 … Continue Reading

Upcoming Webinar: Trends in Pharmaceutical and Medical Device Patent Litigation (February 11, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series we will be presenting a program on pharmaceutical and medical device patent litigation trends on February 11, 2015 (12:30-2:00 p.m. EST). Panelists and topics include: Shara Aranoff – Current trends in Section 337 patent litigation at the ITC, including the evolving domestic industry requirement and the … Continue Reading

CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites

On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct … Continue Reading

FDA Issues Draft Guidance on 510(k) Transfers

In late December 2014, FDA published a draft guidance entitled, “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers,” which provides information to industry on how to notify FDA of the transfer of a 510(k) clearance from one person to another.  The draft guidance also outlines procedures that FDA staff and industry should … Continue Reading

China Issues Multiple Final Rules and Proposals to Implement Recent Revisions to its Core Medical Device Regulation

Throughout August 2014, the China Food and Drug Administration (CFDA or the Agency) made significant process in issuing finalized rules and guidances to implement the revisions to its core medical device regulation, the Medical Device Supervision and Administration Regulation (MDR) (see our alert, here).  The State Council revised the MDR in March, and it went … Continue Reading

Supreme Court Seeks Solicitor General’s Views on Cert Petition in Closely-Watched Preemption Case

In January, we wrote about the Ninth Circuit’s controversial ruling in Stengel v. Medtronic, holding that the plaintiff’s product liability claims, which were premised on Medtronic’s alleged failure to report post-approval information regarding its pain pump to the FDA, were not preempted.  For a detailed discussion of the case, please refer to our previous post.  … Continue Reading

Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

As discussed in our previous post on our sister blog Inside EU LifeSciences, Privacy Impact Assessments (PIAs) or data protection impact assessments used to be discussed in the context of specific technologies or industry sectors (see, for instance, the European Commission’s recommendations in relation to applications supported by radio-frequency identification (RFID) and the development of smart grids). However, … Continue Reading

Senator Leahy is the Latest to Pressure NIH to Exercise Bayh-Dole March-In Rights

An issue device manufacturers may not always fully consider when developing products from government-funded research is the Bayh-Dole Act’s authorization for a federal funding agency (for drugs and devices, often the National Institutes of Health) to “march-in” to the intellectual property rights of the inventor.  Although, to date, the NIH has refused to exercise its … Continue Reading

Coalition Seeks to Delay Mobile Medical Apps Guidance

This July will mark the two-year anniversary of FDA releasing its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  Finalizing the guidance document is listed as an “A list” item on the Center for Devices and Radiological Health’s proposed guidance development for Fiscal Year 2013, and … Continue Reading

FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

Growth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory Questions

Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users’ lifestyles.  Jawbone’s UP can track sleep, movement, and diet, … Continue Reading

FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year

As we have reported previously, the regulation of mobile medical apps continues to be an issue on Congress’ radar.  Last week, the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices, how technological advancements … Continue Reading

Congress Shows Continued Interest In Mobile Medical Apps

Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of a “device.”  On March 1, 2013, six Republican members of the House Committee on Energy and Commerce sent a letter to … Continue Reading

Device Companies May Seek an Increase in Federal Supply Schedule Contract Prices to Accommodate Device Tax

As we’ve previously described, Section 4191 of the Internal Revenue Code imposes a 2.3% excise tax on the sale of certain medical devices by the manufacturers/importers of the devices.  In December of 2012, the Internal Revenue Service (IRS) issued final regulations and interim guidance regarding the determination of sale price and other issues related to … Continue Reading

Rethinking FDA’s Regulation of Mobile Medical Apps

In the Winter/Spring edition of the SciTech Lawyer, published by the American Bar Association’s Section of Science & Technology Law, Scott Danzis and Chris Pruitt argue that FDA should rethink its approach to regulating mobile medical apps, including making significant revisions to its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff: Mobile … Continue Reading

Caronia Update: Government Does Not Appeal Significant Second Circuit Decision

The federal government will not appeal the decision of a Second Circuit panel in United States v. Caronia.  The government did not petition for rehearing by the panel or the en banc Second Circuit before the January 16 deadline.  Further, the Wall Street Journal and others are reporting that FDA officials have confirmed that the government … Continue Reading

Summary of Four Recent FDA Warning Letters on Device Advertising/Promotion Activities Now Available

In November, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) posted on its website four warning letters relating to the advertising and promotion of medical devices: Warning letter to Quanta Systems, S.p.A. re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18, 2012) Warning letter to NeuroMed Devices, Inc. … Continue Reading

U.S. v. Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to off-label promotion.  The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for … Continue Reading

“TEST Act”: Newly Enacted Law Grants CMS Discretion for Sanctioning Referral of Proficiency Tests

On Tuesday, President Obama signed into law the “Taking Essential Steps for Testing Act of 2012,” H.R. 6118, granting the Centers for Medicare and Medicaid Services (CMS) discretion to choose appropriate sanctions for clinical laboratories that are found to have intentionally referred proficiency test samples in violation of the Clinical Laboratory Improvement Amendments (CLIA). In … Continue Reading

ABA Section of Science & Technology Law Creates New Medical Devices Committee

The medical devices industry is a global industry at the forefront of medical technology and innovation.  And the ABA’s Section of Science & Technology Law (SciTech) explores emerging issues at the intersection of law, science, and technology.  This fall, SciTech launched a new medical devices committee to advance public understanding and shape the development of law and … Continue Reading