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Regulatory Oversight Manufacturers Software

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Troutman Pepper Locke

Consumer Advocacy Groups Urge FTC to Address Software Tethering Issues

Troutman Pepper Locke on

The Internet of Things (IoT) represents a transformative shift in how consumers interact with technology, integrating physical devices with sophisticated services to create interconnected ecosystems. As the adoption of IoT...more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Venable LLP

Preparing for the EU Cyber Resilience Act

Venable LLP on

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

Hogan Lovells on

On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

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