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Medical Devices › Investigational Device Exemptions

Hogan Lovells

U.S. Congress embraces FDA’s approach to clinical trial diversity in new Omnibus legislation

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In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

Hogan Lovells

FDA warns over use of robotically-assisted surgical devices

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in...more

Hogan Lovells

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

Hogan Lovells on

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

Robinson+Cole Health Law Diagnosis

FDA Amends Regulations For Data From Foreign And Domestic Investigation For Medical Devices

Robinson+Cole Health Law Diagnosis on

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more

Hogan Lovells

FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement...

Hogan Lovells on

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more

Morgan Lewis

FDA Uses Summer to Issue Numerous Device Guidance Documents

Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Morgan Lewis

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

Morgan Lewis on

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

McDermott Will & Emery

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

McDermott Will & Emery on

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

King & Spalding

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

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The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more

King & Spalding

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

King & Spalding on

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

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