Unique Device Identifiers

News & Analysis as of

No Idea about UDI: FDA Issues Draft Guidance on UDI Form and Content

In advance of the September compliance date for Class II medical devices, the Food and Drug Administration has issued draft guidance on the form and content of Unique Device Identifiers (UDIs).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

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

"Privacy & Cybersecurity Update - July 2016"

In this edition of our Privacy & Cybersecurity Update, we discuss the revised Privacy Shield and what companies should be doing to prepare for the new program, the FTC's reinstatement of its LabMD case, the European...more

FDA Releases Draft Guidance for Unique Device Identifiers

The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users.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

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

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

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

No VPPA Liability for Disclosure of Certain Anonymous Digital Identifiers

Another court has contributed to the ongoing debate over the scope of the term “personally identifiable information” under the Video Privacy Protection Act – a statute enacted in 1988 to protect the privacy of consumers’...more

Third Circuit Tackles New VPPA and Other Privacy Questions in In re Nickelodeon Consumer Privacy Litigation

The Third Circuit Court of Appeals handed the defendants a partial victory in In re Nickelodeon Consumer Privacy Litigation on June 27. While its decision last year in In re Google Inc. Cookie Placement Consumer Privacy...more

FDA Outlines Future Medical Device Coordinating Center

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

FDA Medical Device Safety Tracking System Reform

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

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

CPMI and IOSCO consult on harmonising UPI

BIS’ Committee on Payments and Market Infrastructure (CPMI) and IOSCO are consulting on a harmonised global unique product identifier (UPI). The UPI will uniquely identify OTC derivatives products that authorities require to...more

CMS Adopts Changes to Medicare & Medicaid EHR Policies

The Centers for Medicare & Medicaid Services (CMS) has published a sweeping final rule with comment period that specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals...more

Health Care Update - July 2015

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

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

Too Much Information – Eleventh Circuit’s Review of Ellis May Define “Personally Identifiable Information” for Cell Phone Users

On March 2, 2015, The Cartoon Network Inc. (“Cartoon Network”) filed its response brief in Mark Ellis v. Cartoon Network Inc., asking the Eleventh Circuit Court of Appeals to uphold the district court’s dismissal of the...more

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

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

FDA Releases Unique Device Identification Final Rule, Draft Guidance

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

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer,...more

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