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Healthcare › 510(k) RTA

Epstein Becker & Green

Unpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship

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Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k).  At a high level, I observe that on average clearance can take 160 days according to the data.  Then, beyond that, I...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

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Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who are unable to...more

Knobbe Martens

FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment

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ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The...more

Knobbe Martens

FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment

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Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety.   The clearance was supported by data collected from a...more

Epstein Becker & Green

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

Epstein Becker & Green on

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA...more

Knobbe Martens

FDA Clears Sonic DL™ for Cardiac MRI Scans

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On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™.  GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

Butler Snow LLP on

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

Don’t Go Changing . . . Unless You Ask FDA

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The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

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In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

Robinson+Cole Health Law Diagnosis on

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Sheppard Mullin Richter & Hampton LLP

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial...

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On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals...more

Mintz - Health Care Viewpoints

Device Modernization Series: In Vitro Clinical Tests

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In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

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Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Hogan Lovells

FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

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On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more

King & Spalding

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

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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

Foley & Lardner LLP

Considering Sex-Specific Variation for Personalized Medicine

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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

Pillsbury - Internet & Social Media Law Blog

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

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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

King & Spalding

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

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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

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