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Health Care Providers › Premarket Approval Applications

Epstein Becker & Green

In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

Epstein Becker & Green on

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

Faegre Drinker Biddle & Reath LLP on

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Jones Day

The FDA and Cybersecurity: How the Agency is Addressing Cybersecurity Risks to Medical Devices

Jones Day on

The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more

White and Williams LLP

OIG Recommendations to the FDA for Medical Device Cybersecurity: Foretelling Additional Regulation and Requirements for Controls?

White and Williams LLP on

With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more

Mintz - Health Care Viewpoints

Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation

Mintz - Health Care Viewpoints on

Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

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