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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 medical software. Specifically, Yarmela assists clients in assessing FDA requirements for a variety of software 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’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, 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
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
"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
"The Premarket Approval Application." Medical Device Development: Regulation and Law, Barnett International