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Results:1-10 of 32

FDA Provides Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals
  • Duane Morris LLP
  • USA
  • November 27 2018

The Food and Drug Administration recently issued draft guidance entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in


New FDA Draft Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals
  • Duane Morris LLP
  • USA
  • November 27 2018

The Food and Drug Administration recently issued draft guidance entitled "Consideration of Uncertainty in Making Benet-Risk Determinations in Medical


House Passes the American Health Care Act to Repeal and Replace Affordable Care Act
  • Duane Morris LLP
  • USA
  • May 5 2017

Even though the repeal and replacement of the ACA seems on its way, the ACA still remains the law of the land. Employers should


House Republicans Take Initial Step to Repeal and Replace the Affordable Care Act with the American Health Care Act
  • Duane Morris LLP
  • USA
  • March 7 2017

It must be emphasized that the AHCA is only a proposed bill from House Republicans at this point. It is not the law and employers should not change


Are you emotional about your med device?
  • Duane Morris LLP
  • USA
  • April 15 2015

Steve Honig reports on the April 10, 2015 MassMEDIC presentation on integrating the "human factor" into medical device design, as well as the March 6


Mobile medical apps guidance
  • Duane Morris LLP
  • USA
  • October 4 2013

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last


FDA draft guidance details key cybersecurity management measures expected in medical device submissions
  • Duane Morris LLP
  • USA
  • July 17 2013

Last month, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance for the Content of Premarket Submissions for Management of


FDA enforcement action against uChek: does it signal an agency wake-up call for non-compliant mobile medical apps?
  • Duane Morris LLP
  • USA
  • June 3 2013

In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time


mHealth and the FCC: what does the FCC have to do with medical devices?
  • Duane Morris LLP
  • USA
  • November 14 2012

One might not associate the Federal Communications Commission (FCC) with mHealth issues.


Alivecor veterinary ECG model paves FDA-friendly path to the market
  • Duane Morris LLP
  • USA
  • November 14 2012

In a recent move that mobile medical application developers may want to emulate, AliveCorthe developer of a mobile electrocardiogram (ECG) system awaiting U.S. Food and Drug Administration (FDA) blessing for human usehas introduced what appears to be essentially the identical product for the veterinary market, and without getting FDA's permission.