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Healthcare › Final Guidance

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...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

Quarles & Brady LLP

Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation

Quarles & Brady LLP on

On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more

Epstein Becker & Green

Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care

Epstein Becker & Green on

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software. How has this document caused confusion for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Skadden, Arps, Slate, Meagher & Flom LLP on

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

Robinson+Cole Health Law Diagnosis

CMS Finalizes Guidance on Hospital Co-Location

Robinson+Cole Health Law Diagnosis on

On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

Wilson Sonsini Goodrich & Rosati on

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

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

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Hogan Lovells

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

Hogan Lovells on

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

King & Spalding

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

King & Spalding on

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

McDermott Will & Emery

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

McDermott Will & Emery on

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

Polsinelli

FDA Releases Final Cybersecurity Guidance for Medical Devices

Polsinelli on

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

Morgan Lewis

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

Morgan Lewis on

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

Baker Donelson

HUD Helps Clear Confusion in Loans to the Long Term Care Industry

Baker Donelson on

Overview - New Guidance from HUD. By now, long term care project owners are very aware of the advantages of HUD-insured financing. However, HUD's program policies continue to challenge some providers who own and/or operate...more

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