Rebecca Jones McKnight

Rebecca Jones McKnight

DLA Piper

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Latest Publications


Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

9/22/2016 - Cybersecurity FDA Manufacturers Medical Devices Popular Regulatory Standards Reporting Requirements

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

5/3/2016 - Chief Compliance Officers Data Protection Draft Guidance FDA Pharmaceutical Industry Warning Letters

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

2/2/2016 - Cybersecurity Draft Guidance FDA Manufacturers Medical Devices Popular

Wellness innovators take note: FDA reveals risk-based approaches to the regulation of health IT and mobile medical apps

The way consumers access and interact with health information has changed exponentially over the past few years thanks to rapid innovation in health IT. Mobile medical application developers and other health and wellness...more

2/3/2015 - FDA Health IT Innovation Medical Devices Mobile Apps Mobile Medical Applications Popular Technology

Offering health care solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps

Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders...more

10/11/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps

News and Insights from Austin - Q2 2013

Welcome to the summer issue of News and Insights. In this issue, I’m proud to highlight Becca McKnight, who was recently selected by The Food and Drug Law Institute (FDLI) to serve on its Medical Devices Committee. Becca...more

7/10/2013 - FDA Illegal Drugs Pharmaceutical Industry Quality Control Plan Trade Secrets Uniform Trade Secrets Acts

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