News & Analysis as of

Investigational Device Exemptions

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

by 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

New Clinical Trial Rule Alters Reporting Requirements

by Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

by 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

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

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The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

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On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

by Reed Smith on

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

by King & Spalding on

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

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

by 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

FDA Issues Proposed Rule Amending Regulations Regarding Acceptance of Data from Clinical Studies for Medical Devices

by King & Spalding on

On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more

9 Results
|
View per page
Page: of 1
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!