Premarket Approval Applications

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

by King & Spalding on 3/12/2013

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

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

by King & Spalding on 2/27/2013

On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor

by Loeb & Loeb LLP on 1/17/2013

The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen...more

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

by King & Spalding on 1/9/2013

On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket...more

FDA Issues Final Guidance on Filing PMAs and 510(k)s

by Seth Mailhot, Peter Reichertz | Sheppard Mullin Richter & Hampton LLP on 1/5/2013

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

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