Tag: Medical device

Congress Takes Step Towards Scrapping Device Tax

Yesterday, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of scrapping the tax. The vote came amid the threat of a veto from the […]

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In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present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

OIG Releases New Guidance for Board Oversight of Corporate Compliance Programs

Earlier today, the U.S. Department of Health and Human Services Office of Inspector General (OIG), in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA), announced the release of a guidance document titled, “Practical Guidance for Health Care […]

AMA Tackles Conflicts of Interest with Industry

Interactions between health care professionals and industry representatives was a key topic at the American Medical Association (AMA) House of Delegates (HOD) meeting this week. As reported in BNA today (subscription required), the AMA HOD supported a resolution on June 9th that seeks greater consistency among conflicts of interest policies […]

Resource Launch: Introducing Cooley’s Government Settlements Tracker

Cooley has added an exciting new resource to our blog: the Government Settlements Tracker.  This tracking chart provides an overview of select government settlements related to pharmaceutical, biotechnology and medical device manufacturers, including the settlement amount, whether the matter is civil and/or criminal, whether the matter resulted from a whistleblower action, resolution of the matter, and […]

FDA Issues Final Guidance Regarding Mobile Medical Applications

The U.S. Food and Drug Administration (FDA) announced today the issuance of its final guidance regarding mobile medical applications, defined by FDA as software programs that run on mobile communication devices and perform the same functions as traditional medical devices.  This final guidance finalizes draft guidance that was issued by the FDA on […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]