Elizabeth Guo

Law Clerk

Elizabeth Guo received her law degree from Harvard Law School and her M.P.H. from the Harvard School of Public Health in 2016.  She is not yet admitted to practice law but is supervised by principals of the firm.

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FDA Draft Guidance Addresses Medical Device Status of Microneedling Products

On September 15, 2017, FDA published a draft guidance document titled “Regulatory Considerations for Microneedling Devices” (Draft Guidance). The Draft Guidance describes when a microneedling product is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and discusses the regulatory pathway for microneedling devices. Interested parties have 60 days, … Continue Reading

FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] … Continue Reading

FDA Announces a New Digital Health Innovation Plan

FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century … Continue Reading

House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests

On March 20, 2017, Rep. Larry Bucshon (R-IN) and Rep. Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA).  DAIA would regulate “in vitro clinical tests,” defined in the discussion draft as a “laboratory test protocol or finished product” intended for clinical use “in the collection, preparation, analysis, or … Continue Reading

Medical Device Tax Repeal Included in the American Health Care Act

On March 9, the House Energy and Commerce Committee and the House Ways and Means Committee favorably reported out the American Health Care Act (AHCA) — the Republican Affordable Care Act (ACA) repeal legislation.  The AHCA includes a provision to repeal the medical device excise tax, which was originally enacted as a cost savings component of the ACA.  … Continue Reading

2016 Year in Review: MDR Reporting Enforcement

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 … Continue Reading

FDA and CMS Permanently Establish Parallel Review

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 … Continue Reading
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