Category: Medical Devices

General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present a low risk to users. Cooley recently collaborated with Worrell to develop […]

The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? If you answered yes to both questions, then you need to understand the Trade Agreements Act […]

Resource Launch: Key Considerations for Health Care Fraud Government Investigations/Inquiries

Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a […]

Resource Launch: 20 Key Considerations for Implementing an Effective Corporate Compliance Program

Cooley is excited to release a new resource for health care and life sciences companies: 20 Key Considerations for Implementing an Effective Corporate Compliance Program.  This quick reference document provides an overview of key areas that a company should consider as it seeks to implement and improve its corporate compliance programs. […]

FDA Cybersecurity Workshop for Healthcare

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”  The FDA held this public workshop in order to bring together stakeholders in […]

Cooley Communications Blog Post re: New FCC Rules for Medical Body Area Networks

Cooley’s Communications Regulatory group posted on its blog an article titled, New FCC Rules for Medical Body Area Networks.  According to the Federal Communications Commission, Medical Body Area Networks (MBANs) technology allows for “the wireless networking of multiple body-worn sensors used for measuring and recording physiological parameters and other patient information or for […]

The 3D Printing Revolution Meets Health Care

On June 17, Cooley LLP and NYC Health Business Leaders co-hosted “The 3D Printing Revolution Meets Health Care,” a cutting-edge event addressing the state of the 3D printing (3DP) revolution in health care. The event defined the current and future market, described the business, operational, legal and regulatory issues confronting […]