Premarket Approval Applications

News & Analysis as of

What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.

On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more

Good News for Hospitals: FDA Eases Up on Medical Device Data Systems

A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the...more

Careful What You Say – No Preemption for Statements Made in Operating Room

Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

Cybersecurity Measures to be Included in Premarket Submissions for Medical Devices

The FDA recently issued a Safety Communication on cybersecurity and medical devices and draft guidance recommending that manufacturers specifically address cybersecurity in premarket submissions for medical devices....more

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

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FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

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

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

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

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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