News & Analysis as of

Final Guidance Medical Devices

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

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Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

King & Spalding

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

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On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

Knobbe Martens on

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Goodwin

FDA Issues Final Clinical Decision Support Software Guidance

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​​​​​​​On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the...more

McDermott Will & Emery

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

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On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more

Foley & Lardner LLP

Developers Take Note: FDA Issues Clinical Decision Support Software Final Guidance

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On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more

Hogan Lovells

FDA delays UDI database enforcement for low-risk devices

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On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more

Hogan Lovells

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

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Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

Faegre Drinker Biddle & Reath LLP

FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be 'Recall Ready'

The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more

Manatt, Phelps & Phillips, LLP

FDA Issues Final Guidance on the Safer Technologies Program (STeP) for Medical Devices

On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal...more

K&L Gates LLP

K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

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FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

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Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

McDermott Will & Emery

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

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The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance on Special 510(k) Pathway

The Food and Drug Administration (FDA) recently finalized its guidance on the Special 510(k) Program—an optional pathway to commercial medical devices that have been modified since their previous 510(k) clearance. The Special...more

Hogan Lovells

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

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On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices

The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should...more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Hogan Lovells

FDA releases final guidance document on PMA manufacturing site change supplements

Hogan Lovells on

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

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A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

McDermott Will & Emery

FDA Finalizes Guidance on Payor Communications

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On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more

Cooley LLP

Blog: FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

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The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities —...more

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