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Yarmela Pavlovic
Partner, San Francisco
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yarmela.pavlovic@hoganlovells.com

Yarmela Pavlovic's practice focuses primarily on the U.S. Food and Drug Administration (FDA)'s regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. Yarmela has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs, and PMAs), as well as providing advice on a variety of other device-related regulatory issues.

Yarmela has particular experience in the area of FDA regulation of mobile health and medical software and applications. Specifically, Yarmela assists clients in assessing FDA requirements for a variety of mobile health products, as well as developing premarket strategies where necessary. Yarmela regularly counsels clients regarding strategic plans that not only comply with government regulations, but also achieve their business objectives.

Yarmela has authored a number of articles on FDA regulatory issues related to mobile health, Health IT, and medical device premarket pathways and has been an invited speaker in a variety of settings.

Yarmela's experience also includes counseling of medical device companies in relation to the advertising and promotion of medical devices. Yarmela assists clients in ensuring compliance with FDA requirements through in-depth reviews of various promotional materials placed on clients' global and local websites, as well as social media platforms and printed and multimedia materials. Yarmela provides clients with strategic advice regarding development of online marketing strategies and policies.

Prior to joining the practice, Yarmela defended medical device manufacturers and pharmaceutical companies in relation to products liability litigation at a Philadelphia law firm. While in law school, she served as the publication manager for the Michigan Journal of Gender & Law. Yarmela also spent a summer clerking for the Office of the Federal Public Defender in Portland, Oregon.

Hogan Lovells Publications
21 January 2015 "FDA Holds Workshop on Proposed Regulatory Framework for Laboratory Developed Tests." Medical Device Alert, Hogan Lovells

19 August 2014 "FDA Releases Revised De Novo Pathway Guidance." Medical Device Alert, Hogan Lovells

05 August 2014 "FDA Notifies Congress of the Proposed Regulatory Oversight of Laboratory Developed Tests." Medical Device Alert, Hogan Lovells

24 June 2014 "FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices." Medical Device Alert, Hogan Lovells

09 June 2014 "FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop." Medical Device Alert, Hogan Lovells

07 May 2014 "FDA Releases Draft Guidance Documents on New Expedited Access Program for Premarket Approval of Medical Devices and Premarket and Postmarket Data Collection." Medical Device Alert, Hogan Lovells

07 April 2014 "FDA, FCC, and ONC Jointly Issue Highly Anticipated Health IT Report, Recommending a Three-Tiered, Risk-Based Approach to Regulation." Medical Device Alert, Hogan Lovells

23 January 2014 "New Rules for Navigating the Blogosphere and Twitterverse: FDA's Draft Guidance on Submissions of Interactive Promotional Media." Pharmaceutical and Biotechnology Alert, Hogan Lovells

01 October 2013 "FDA Finalizes Mobile Medical Apps Guidance." Medical Device Alert, Hogan Lovells

16 September 2013 "FDA Considers New FDASIA Workgroup Recommendations for Regulating Health IT." Medical Device Alert, Hogan Lovells

22 March 2013 "Congressional subcommittees hold hearings on Health IT." Medical Devices Alert, Hogan Lovells

04 August 2011 "FDA issues draft 510(k) device modification guidance." Medical Device Alert, Hogan Lovells

25 July 2011 "Guidance addressing regulation of smartphone and tablet computer apps." Medical Device Alert, Hogan Lovells

23 February 2011 "FDA finalizes long-awaited Medical Device Data Systems rule." Medical Device Alert, Hogan Lovells

27 January 2009 "GAO Report Urges the FDA to Issue Regulations Addressing Class III Products in 510(k) Pathway." Medical Device Update, Hogan & Hartson LLP

Published Works
04 September 2014 "FDA Draft Guidance Could Spur Innovation in Diabetes, Cardio Spaces." MD+DI

11 July 2014 "FDA Shifts Health IT Policy Stance With Multiple Updates." eHealth Law & Policy

17 June 2014 "Faster FDA Approval for Medical Devices Coming Soon." Law360

November 2013 "FDA Issues Final Guidance on Mobile Medical Applications." eHealth Law & Policy

26 September 2013 "FDA's Final Guidance: Some Answers, Some Surprises, and Some Questions." mHealthNews

18 April 2013 "10 issues that mobile medical app developers should keep in mind." mHIMSS, HIMSS and Healthcare IT News

2009 "The Premarket Approval Application." Medical Device Development: Regulation and Law, Barnett International

PRACTICES
Food, Drug, Medical Device and Agriculture
Medical Devices
INDUSTRY SECTORS
Life Sciences and Healthcare
Medical Devices
EDUCATION
J.D., University of Michigan Law School, 2003 B.S., magna cum laude, Linfield College, 2000
AWARDS / RANKINGS
  • First Judicial District of Pennsylvania 2008-2013 Pro Bono Roll of Honor
  • Pennsylvania Super Lawyers Rising Star 2014
BAR ADMISSIONS / QUALIFICATIONS California Pennsylvania
COURT ADMISSIONS U.S. District Court, Eastern District of Pennsylvania