Morgan Lewis

Related Publications

10/30/14 Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements
The final guidance clarifies when a change to a device constitutes a medical device recall, distinguishes device recalls from device enhancements, and clarifies reporting requirements under 21 C.F.R. Part 806.
08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process
The draft provides guidance on a streamlined process for submitting requests to the FDA to down-classify certain low-to-moderate-risk devices that have been automatically classified as Class III.
08/06/14 Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged
On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key changes to FDA’s policies that may affect their 510(k) submissions, including new limitations on the use of multiple predicates, the unacceptability of split predicates, an increase in the content and detail required for 510(k) summaries, and FDA’s intent to “verify the accuracy and completeness” of 510(k) summaries.
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Related News

08/28/13 Device Reporting Changes Could Increase Burden On Industry, FDA, Inside Health Reform
FDA associate Michele Buenafe is quoted.
05/22/13 FDA Shows Deft Touch With 1st Mobile App Enforcement, Law360
FDA & Healthcare associate Michele L. Buenafe is quoted.
View all news
Photo of  Michele L. Buenafe

practice accolades

FDA

Named the Healthcare Pricing and Reimbursement Firm of the Year by LMG Life Sciences (2013)

Ranked the second-largest U.S. healthcare law firm by Modern Healthcare (2012–2013)

Recognized as a top 10 law firm within the Life Sciences Regulatory Super League by The Practical Law Company (PLC) (2012)

Listed as Recommended in PLC's Life Sciences Multi-Jurisdictional Guide (2012)

honors + affiliations

Member, Food & Drug Law Institute Medical Devices Committee, (2013–2016)

Member, Food & Drug Law Institute Editorial Advisory Board, Update Magazine (2010–2012)

Staff Member, American Intellectual Property Law Association Quarterly Journal (2003–2005)

bar admissions

  • District of Columbia
  • Maryland
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Michele L. Buenafe
Associate


Email: mbuenafe@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States
Phone: +1.202.739.6326
Fax: +1.202.739.3001

Michele L. Buenafe is an associate in Morgan Lewis's FDA Practice. Her practice focuses on federal and state regulatory, compliance, and enforcement issues pertaining to medical devices, health information technology, pharmaceuticals, controlled substances, and human tissue products.

As part of her practice, Ms. Buenafe regularly advises clients on issues related to the development, manufacturing, and marketing of medical devices, pharmaceuticals, human tissue products, and combination products; labeling and advertising; FDA registration and listing; product recalls; and medical device reporting and other post-market reporting requirements.  She also advises on issues related to the federal Controlled Substances Act and Drug Enforcement Administration (DEA) regulations. In addition, Ms. Buenafe assists clients in navigating the state regulatory requirements (including licensure requirements) applicable to drug and device manufacturers, wholesale distributors, pharmacies, DME suppliers, healthcare providers, and controlled substances and listed chemicals. She also advises clients on the regulatory requirements and emerging legal issues related to medical device data systems (MDDS), mobile medical apps, clinical decision support software, and other health information technology. She has spoken at medical device industry conferences on FDA regulatory issues affecting devices and health information technology and is an active participant in the Food and Drug Law Institute/FDA In-House Training Program.

Representative matters include:

  • Assistance in responding to FDA, DEA, and state enforcement correspondence, including FDA 483s, Warning Letters, untitled letters, and state board inquiries.
  • Addressing all forms of FDA regulatory issues and related state compliance matters in M&A transactions involving FDA regulated products (e.g., medical devices, health IT products, pharmaceuticals, and human tissues products), including regulatory due diligence, compliance representations and indemnification, and structured payments for achieving regulatory milestones.
  • Handling all forms of transactional agreements, including purchase and supply, clinical trial, co-marketing, contract manufacturing, distribution, and quality agreements.
  • Providing advice and assistance to a large technology company not previously subject to FDA regulation in connection with an FDA inspection related to its remote monitoring system. Advised on FDA requirements related to product marketing, MDDS requirements, establishment registration, quality systems, complaint handling, and medical device reporting.
  • Providing routine advice to clients marketing medical image storage and display devices, MDDS devices, and general purpose IT products (including both hardware and software applications) to healthcare customers to assess FDA regulatory obligations and potential premarket pathways.
  • Review of marketing materials to ensure compliance with FDA requirements, including any applicable approval or clearance.

Prior to joining Morgan Lewis, Ms. Buenafe worked at a consulting group, where she assisted on matters concerning pharmaceutical CGMP compliance.

Ms. Buenafe earned her J.D., high honors, from the George Washington University Law School in 2005. During law school, Ms. Buenafe served on the American Intellectual Property Law Association Quarterly Journal. In 1999, she earned her B.S. in chemical engineering from the University of Arizona.

Ms. Buenafe is admitted to practice in the District of Columbia and Maryland.

education

  • George Washington University Law School, 2005, J.D., High Honors
  • University of Arizona, 1999, B.S.