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Food and Drug Administration (FDA) Unique Device Identifiers

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 18

McGuireWoods LLP on

This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more

Sheppard Mullin Richter & Hampton LLP

FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products

With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...more

Hogan Lovells

FDA delays UDI database enforcement for low-risk devices

Hogan Lovells on

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

Arnall Golden Gregory LLP

I Can See Clearly Now: FDA Issues Final Guidance on the Form and Content of the Unique Device Identifier

Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: Form and Content of the...more

Morgan Lewis

FDA Extends UDI and Direct Marking Enforcement Discretion for Class I and Unclassified Devices to 2022

Morgan Lewis on

The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...more

Kelley Drye & Warren LLP

Keep Calm and Go Online: Regulatory Considerations Around the Spike in Demand for Mental Health Apps

A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention. As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased...more

Mintz - Health Care Viewpoints

FDA Expands Face Mask Enforcement Policy to Allow Imports of KN95 Respirators

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more

Robinson+Cole Data Privacy + Security Insider

Cybersecurity Risks in Medical Devices Discussed at Recent FDA Meeting

The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more

Knobbe Martens

Netherlands Adopts US FDA-based UDI System for Medical Devices

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A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

Hogan Lovells

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

McDermott Will & Emery

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

McDermott Will & Emery on

In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more

Saul Ewing LLP

FDA Update: Menu Labeling Delay Suit, Research Oversight Change, UDI Compliance Date Delays, and Inspection Staff Reorganization

Saul Ewing LLP on

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has taken a number of actions that could impact nearly all of the industries it regulates, but in particular, companies in the medical...more

Kilpatrick

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

Kilpatrick on

With the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e.,...more

McDermott Will & Emery

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

McDermott Will & Emery on

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

Morgan Lewis

FDA Uses Summer to Issue Numerous Device Guidance Documents

Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Arnall Golden Gregory LLP

No Idea about UDI: FDA Issues Draft Guidance on UDI Form and Content

In advance of the September compliance date for Class II medical devices, the Food and Drug Administration has issued draft guidance on the form and content of Unique Device Identifiers (UDIs). Though the UDI Rule was...more

Holland & Knight LLP

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

Knobbe Martens

FDA Releases Draft Guidance for Unique Device Identifiers

Knobbe Martens on

The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of...more

Mintz

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

Mintz on

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

Foley & Lardner LLP

FDA Outlines Future Medical Device Coordinating Center

Foley & Lardner LLP on

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

Knobbe Martens

FDA Medical Device Safety Tracking System Reform

Knobbe Martens on

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

Arnall Golden Gregory LLP

FDA Releases Draft Guidance on UDI Requirements for Convenience Kits

On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged together as “convenience...more

Mintz - ML Strategies

Health Care Update - July 2015

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In This Issue: - Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...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

BakerHostetler

FDA Releases Unique Device Identification Final Rule, Draft Guidance

BakerHostetler on

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

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