News & Analysis as of

Office of the Inspector General Medical Devices Regulatory Requirements

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Morgan Lewis

OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties

Morgan Lewis on

The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more

Polsinelli

OIG Issues Guidance on Speaker Programs By Drug and Device Companies

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This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...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

Knobbe Martens

FDA to Strengthen Cybersecurity Oversight

Knobbe Martens on

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more

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