Search Results for UDI

Showing 1 – 25  of 50

CDRH Looks Ahead to Priorities for 2018 to 2022 By Zachary Brennan - Published 17 January 2018

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: novel devices, UDI, NGS

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 Delays UDI Requirements for Low-Risk Devices By Michael Mezher - Published 05 June 2017

The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.

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

Tags: Unique Device Identifier, UDI

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

Committee Recommends Adding UDIs to Insurance Claims Forms By Michael Mezher - Published 03 February 2017

The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: UDI, Unique Device Identifier, X12, Accredited Standards Committee, Claims Forms

HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms By Michael Mezher - Published 04 October 2016

In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms.

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

Tags: UDI, Claims Forms, Accredited Standards Committee X12

FDA Extends UDI Compliance for Certain Class II Devices By Michael Mezher - Published 07 September 2016

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

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

Tags: UDI, Unique Device Identifier, Class II

Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms By Zachary Brennan - Published 31 August 2016

Incorporating unique device identifiers (UDIs) into health insurance claims forms could help improve the postmarket tracking of medical device safety concerns and performance, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote in a letter earlier this week to the chair of an Accredited Standards Committee.

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

Tags: Chuck Grassley, Elizabeth Warren, UDI, health insurance claims forms

FDA Pushes Back Enforcement of UDI Rule Provisions By Zachary Brennan - Published 29 August 2016

The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.

Categories: News, US, FDA, Labeling, Medical Devices, Packaging, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: UDI Rule, unique device identifier, NDC number, NHRIC number, medical device label

UDI Form and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 25 July 2016

The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule.

Categories: News, US, FDA, Business and Leadership, Labeling, Medical Devices, Postmarket surveillance, Submission and registration

Tags: unique device identifier, UDI, UDI guidance, FDA draft guidance

UDI Compliance: What's Coming From FDA in 2016 By Michael Mezher - Published 18 April 2016

Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told the UDI Conference in Baltimore on Monday.

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

Tags: UDI, Unique Device Identifier, GUDID, Global Unique Device Identifier Database

Pew: Insurance Claims Must Include UDIs to Track Device Safety By Michael Mezher - Published 13 April 2016

The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care.

Categories: News, FDA, Medical Devices, Postmarket surveillance

Tags: Unique device identifier, UDI, claims forms, CMS, Pew Charitable Trusts, Josh Rising

Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms By Michael Mezher - Published 09 March 2016

Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: UDI, Unique Device Identifier, Sen. Elizabeth Warren (D-MA), Sen. Charles Grassley (R-IA), CMS, Centers for Medicare and Medicaid Services

FDA Extends Deadline for Some UDI Requirements for Medical Devices By Michael Mezher - Published 04 February 2016

The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices.

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

Tags: Unique Device Identifier, UDI, National Drug Code, NDC, UDI Rule

How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains By Zachary Brennan - Published 15 January 2016

The US Food and Drug Administration (FDA) is looking to shed more light on how two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements.

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

Tags: UDI rule, unique device identifier, packaged medical devices, device regulations

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

UDIs for Implantable Devices Now Included in Common Clinical Data Set By Zachary Brennan - Published 13 October 2015

For the first time ever, unique device identifiers (UDIs) will have to be included as part of a set of common clinical data intended to help physicians better track patients' implanted devices.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: UDI, unique device identifier, FDA, ONC, health IT

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

Medical Device Regulatory Update: Usability, UDI and RoHS By Lori A. DonDiego, MBA, RAC - Published 23 September 2014

Human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have more in common than one might think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational conference, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU1 aimed at devices currently under Directive 93/42/EEC (MDD) and 90/385/EEC (IVD).

Categories: Features, Europe, US, Compliance, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Packaging

Tags: Human Factors Engineering, HFE, usability engineering, Unique Device Identifiers, UDI, medical electronics, RoHS, restriction of hazardous substances, FDA, EU, directives

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