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Results:1-10 of 27

Digital Health Law: What Digital Health Companies Need to Keep in Mind
  • Venable LLP
  • USA
  • August 23 2017

Healthcare Alert The fast-growing field of digital health is transforming healthcare by bringing together digital communications technology


Unique Device Identification Compliance Deadline for Class II Devices Fast Approaching
  • Venable LLP
  • USA
  • April 25 2016

In just five months, firms marketing Class II medical devices will be required to comply with the U.S. Food and Drug Administration's (FDA)


NTIA Convenes Multistakeholder Process on Cybersecurity Vulnerability Research Disclosure
  • Venable LLP
  • USA
  • December 31 2015

On December 2, 2015, the National Telecommunications and Information Administration (NTIA) convened its second meeting as part of a multistakeholder


3D printing series: 3D printing of medical devices
  • Venable LLP
  • USA
  • April 14 2015

3D printing, also referred to as "additive manufacturing" or "rapid prototyping," is the process of making three-dimensional objects from digital


3D printing series: before you click “print” on your pizza, palette or prosthetic: FDA and IP considerations with 3D-printed foods, cosmetics and medical devices
  • Venable LLP
  • USA
  • March 19 2015

We agree - the Jetsons era has indeed arrived. Beyond the days of "smart" everything, now 3D printing has taken center stage in the tech world. While


FDA publishes draft social media guidance documents
  • Venable LLP
  • USA
  • September 5 2014

The Food and Drug Administration (FDA) has released drafts of two new guidance documents that are relevant to companies offering prescription drugs


IOM recommends elimination of 510(k) process
  • Venable LLP
  • USA
  • November 16 2011

At the direction of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) recently reviewed the 510(k) clearance process for medical devices.


Preemption victory in California medical device consumer class action at the Ninth Circuit
  • Venable LLP
  • USA
  • October 4 2011

In a ruling issued on September 28, 2011, the United States Court of Appeals for the Ninth Circuit held that federal law preempted California consumer class action claims against the manufacturer of a contact lens cleaning solution because those claims would have required the manufacturer to conduct premarket testing beyond that required by the FDA.


FTC zaps acne apps in first mobile app health claim cases
  • Venable LLP
  • USA
  • September 8 2011

The FTC today announced settlements in two separate cases with marketers who claimed their smartphone applications, “AcneApp” and “Acne Pwner,” could help reduce acne by using colored lights emitted from the screen of the user’s mobile device.


FDA releases draft guidance on premarket and 510(k) submission
  • Venable LLP
  • USA
  • August 18 2011

On Monday, the FDA released draft guidance for the design of studies supporting premarket and 510(k) submissions.