Search Results for unique device identification

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FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices By Zachary Brennan - Published 12 January 2018

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices

Tags: unique device identification, Class I, unclassified devices, UDI enforcement

FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers By Zachary Brennan - Published 03 April 2017

The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: contact lens, UDI, unique device identification, GUDID

Industry Weighs Integration of UDIs Into Medical Device Registry Network By Michael Mezher - Published 18 November 2015

The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Coordinated registry networks, CRN, Medical Device Registry Task Force (MDRTF), AdvaMed, Pew Charitable Trusts, Unique Device Identification, UDI

FDA Pushes GUDID Compliance Back for Some Devices Due to Security Flaw By Michael Mezher - Published 19 August 2015

After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: GUDID, Global Unique Device Identification Database, Unique Device Identification

FDA Explains How Medical Device Companies Can Comply With UDI Marking Requirements By Alexander Gaffney, RAC - Published 25 June 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI).

Categories: News, US, CDRH, Labeling, Medical Devices

Tags: UDI, Unique Device Identification, Draft Guidance, Guidance, Marking, UDI Marking

Six Recommendations Regarding Upcoming UDI Compliance Dates By Dan Henrich, Haley Lentz - Published 14 May 2015

This article provides an overview of the medical device industry’s challenges in the next phase of UDI implementation, including a review of the latest best practices for I/LS/LS and Class II device labelers.

Categories: Features, US, CDRH, Labeling, Medical Devices

Tags: UDI, Unique Device Identification, GUDID, Device Identifier, Packaging

FDA Releases Vast Trove of Medical Device Data in Hopes of Transforming Healthcare Delivery By Alexander Gaffney, RAC - Published 05 May 2015

The US Food and Drug Administration (FDA) is opening up one of its vast treasure troves of data to the public in the hopes of improving the way medical devices are integrated into the healthcare delivery system.

Categories: News, US, CDRH, Labeling, Medical Devices, Postmarket surveillance

Tags: GUDID, UDI, Unique Device Identification, Unique Device Identifier, AccessGUDID

US FDA Amends eMDR Rules to align with Unique Device Identification Program By Stewart Eisenhart, Emergo - Published 11 March 2015

US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

Categories: News, US, CDRH, Labeling, Medical Devices, Postmarket surveillance

Tags: Emergo, UDI, Unique Device Identification, eMDR, Medical Device Reporting, 21 CFR 803

US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know By Haley Lentz - Published 24 November 2014

The US FDA Unique Device Identification final rule dictates when submissions must be made to the GUDID database. There are four methods to submit the device record. What are the key considerations for future GUDID submissions and how may device manufacturers keep their options in mind?

Categories: Features, US, FDA, Compliance, Medical Devices

Tags: US, FDA, UDI, GUDID, medical devices, regulations, Global Unique Device Identification Database

FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants By Alexander Gaffney, RAC - Published 20 November 2014

The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.

Categories: News, US, CDRH, Compliance, Labeling, Medical Devices

Tags: UDI, Unique Device Identification, Unique Device Identifier, UDI Marking, UDI Labeling, Device Implant

FDA Extends UDI Compliance Date for Most Contact Lenses By Alexander Gaffney, RAC - Published 20 August 2014

Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry.

Categories: News, US, CDRH, Compliance, Labeling, Medical Devices, Packaging

Tags: UDI, Unique Device Identification, 21 CFR 801.55(d), Direct Marking, GUDID, IOLs, Contact Lenses

FDA Unveils Final Details about Medical Device Tracking System By Alexander Gaffney, RAC - Published 25 June 2014

Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works.

Categories: News, US, CDER, In vitro diagnostics, Medical Devices

Tags: GUDID, UDI, GMDN, Global Medical Device Nomenclature, Unique Device Identification, Global Unique Device Identification Database

FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later By Alexander Gaffney, RAC - Published 10 June 2014

The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define.

Categories: News, US, CDRH, Compliance, In vitro diagnostics, Labeling, Medical Devices

Tags: GUDID, UDI, Unique Device Identification, Unique Device Identifier, Global Unique Device Identification Database, Guidance, Final Guidance

US Health IT Officials Call for Integration of FDA's Unique Device Identification with eHealth Records By Alexander Gaffney, RAC - Published 24 February 2014

Categories: US, FDA, CDRH

Tags: Electronic Health Record, Unique Device Identification, UDI, EHR

Device Manufacturers Get New Option to Ensure Compliance with UDI Rule By Alexander Gaffney, RAC - Published 13 January 2014

Categories: US, FDA

Tags: UDI Rule, Unique Device Identification, UDI

Jay Crowley, Author of FDA's UDI Rule, to Leave Agency for Industry Next Week By Alexander Gaffney, RAC - Published 20 December 2013

Categories: US, FDA, CDRH

Tags: UDI Rule, Unique Device Identification, UDI

Industry Digs into Details of UDI Database Guidance in Comments to FDA By Alexander Gaffney, RF News Editor - Published 05 December 2013

Categories: US, FDA

Tags: UDI Rule, Unique Device Identification, UDI

Was OMB's Lengthy Review of the UDI Rule Worth the Wait? By Alexander Gaffney, RF News Editor - Published 25 October 2013

Categories: US, FDA

Tags: UDI Rule, Unique Device Identification, OIRA, UDI, OMB, Latest News

FDA Releases Unique Device Identification Rule, Reflecting Dozens of Changes Sought by Industry By Alexander Gaffney, RF News Editor - Published 20 September 2013

Categories: US, FDA

Tags: Unique Device Identification, UDI, Latest News

European Commission Releases Harmonized UDI Framework By Alexander Gaffney, RF News Editor - Published 10 April 2013

Categories: Europe, EC, IMDRF

Tags: Unique Device Identification, framework, UDI, Latest News, EU, medical device

FDA Accelerates Implementation Deadline of UDI Rule for Certain Higher-Risk Devices By Alexander Gaffney, RF News Editor - Published 19 November 2012

Categories: FDA

Tags: UDI Rule, Unique Device Identification, FDASIA, Unique Device Identifier, medical device

FDA Acts on Long-Delayed UDI Rule By Karen Long, MSc, RAC - Published 17 September 2012

On 2 July 2012, the US Food and Drug Administration (FDA) published the eagerly awaited proposed rule requiring a unique device identifier (UDI) be placed on the label and packaging of marketed medical devices. The UDI rule was mandated under the Food and Drug Administration Amendments Act of 2007, but has been delayed numerous times. UDIs will provide a number of benefits, which this article explains in detail.

Categories: Features, FDA

Tags: Unique Device Identification, Tracking, UDI, Rule, regulation, medical device

User Fee Bills Would End Unique Device Identifier Stalemate By Alexander Gaffney - Published 05 June 2012

Categories: FDA

Tags: Unique Device Identification, Unique Device Identifier, UDI, OMB, Latest News, medical device