510(k) RTA

News & Analysis as of

The Boston Mesh Litigation

Mesh products have been regularly used to repair abdominal hernias since the 1950s. In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs....more

You Should Know - April 2015

In This Issue: - Devices Go Awry - Protect Against Risks - Insiders Talk - Excerpt from Faulty Products Put Patients at Risk: Some Popular Medical Devices Escape FDA Scrutiny: Countless patients around the...more

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k)...

The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) (“SE Guidance”). The SE...more

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more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

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

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