FDA Extends UDI Compliance Deadline for Some Medical Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is granting a compliance extension of some of the UDI labeling requirements for some non-sterile implantable medical devices, which were otherwise subject to the September 24, 2105 compliance deadline.The new compliance deadline is September 24, 2016 for devices that meet ALL of the following criteria:

Compliance Deadline Extension Criteria

1. classified with primary product codes and regulations listed on the letter to implant labelers
2. single use implants, and
3. intended to be sterilized (or cleaned and sterilized) before use. Most of the devices that meet these three criteria are supplied non-sterile by the manufacturer

USDM Life Sciences will provide more details about the extension at a live webinar on January 15, 2015. USDM’s Jay Crowley, who had primary responsibility for the development and implementation of FDA’s UDI system will lead the presentation.

How Much Should a Project Manager Micromanage Life Sciences Projects?

Kathleen Warner, Vice President of Project and Program Management Services and Solutions says the amount of micromanagement on projects depends on the experience level of the team.  For example, if there is a senior subject matter expert with a good track record on the team for a short term project, micromanagement of the project is not usually necessary.  Warner says a project manager should focus on delegating and facilitating tasks instead.  However, some long term projects may require micromanaging on a daily basis when you run into problems or have an approaching deadline.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

How to Research LIMS Vendors Who Understand Pharmaceutical Regulations

If you have a Legacy LIMS system, talk to your Legacy vendor.  Another good method is to search the Internet for articles that discuss LIMS.  Do a search on the Internet for “top 10 LIMS vendors in regulatory environment.”  You will be able to see some lists of current LIMS vendors as well as articles that discuss LIMS vendors.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

UDI Label Requirements

The U.S. FDA UDI Final Rule requires all dates on labels to be in the standardized date format (YYYY-MM-DD).  The Final Rule also requires a day be specified in the date.  Dates on labels must be in the standardized format by the time the device is required to be compliant with the Final Rule.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Project Management: Rules of Engagement

The best way to eliminate unwanted activities or distractions is to develop a list of “norms” at the project kick-off meeting.  The “norms” are a list of expectations of how you expect the team members to engage.  For example, if you decide you don't want instant messages or text messages as a form of communication, you make it a rule.  If you want communication to be in the form of an email, then you make it a rule.  But, Kathleen Warner, Vice President of Project and Program Management Services and Solutions says rules of engagement should be created as a team because everyone has their own best way to communicate, which should be considered as a team.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

Life Sciences Applications in the Cloud Subject to Compliance Requirements

Some life sciences applications will need to be validated when they are moved to the Cloud. Legacy applications that you have already validated would maintain their validated state. But, often times when companies move applications to the Cloud, they add additional requirements and functionalities. USDM Life Sciences often helps companies move to a cloud based Customer Relationship Management (CRM) system and access their Enterprise Resource Planning (ERP) system in the field so sales staff can handle decision making, manage trunk stock and submit orders remotely. But, if you are moving data back and forth between your cloud based CRM and your ERP system, the data most likely needs to be maintained in a compliant manner.

Ultimately, whether an application must meet compliance requirements depends on the type of data you are using in the Cloud. For example, if you need to be able to track the activity of a medical device with GxP type of data, the application you are using needs to be validated.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences Cloud Solutions and Services provide security, lower costs and ensure compliance.

How Long Does it Take to Implement a New LIMS/Lab System?

The time it takes to implement a new LIMS/Lab System depends on how big it is, how many users you have, whether you are going with an off-the-shelf system or a customized system.  It’s not unheard of for a LIMS system implementation to take over a year, from the time a proposal is requested to completion.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

How to Bring a Life Sciences Project to an End

Some projects seem like they will never end.  In order to help define when a project should come to a logical conclusion, the Project Manager needs to identify the purpose, strategy (high level) and deliverables at the beginning of the project.  When a project seems like it will never end or the scope of the project keeps growing, refer back to the items you identified in the beginning of the project.  Break the project up into phases.  The items you identified at the beginning of the project can be phase one.  Newer parts to the project can be phases two, three etc. with their own purpose, strategy and deliverables.  Organizing each part of a project into phases will provide a roadmap for each part of the project to reach an end point.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

Future of UDI in Healthcare Systems

Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences and former FDA Senior Advisor, led a session on the future of Unique Device Identification (UDI) in healthcare systems at the 2014 UDI Conference. He noted the UDI Rule is flexible, extendable and the conceptual regulatory framework is good; however, we are all learning -- it is an iterative process. As the original legislation called for the use of device identification through “distribution and use,” there is a lot of work to be done to achieve the public benefits of UDI. The Rule was designed to evolve and grow. To improve FDA’s post market surveillance activities, the Rule’s conforming amendments mandate the UDI in adverse event reports from healthcare providers and manufacturers. So what’s next? Talk to your stakeholders, trading partners and issuing agencies about standards.

We’re listening, email us your thoughts at ComplianceSolutions@usdm.com.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet regulatory requirements, including the Drug Supply Chain Security Act, Unique Device Identification and Meaningful Use Rule.

** The FDA Amendments Act (FDAAA) of 2007 and FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act directed FDA to establish a UDI system.

FDA Will Share Data from UDI Database with Healthcare Providers

At the 2014 UDI Conference, FDA commented on their plans to share Unique Device Identification (UDI) data from the Global UDI Database (GUDID) with healthcare providers and the public. Approximately 33,000 records have been uploaded to the GUDID and once a meaningful set of data records are established (anticipated in Jan 2015), they will share through the National Library of Medicine (NLM) website where pharmaceutical label information is currently stored.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet regulatory requirements, including the Drug Supply Chain Security Act, Unique Device Identification and Meaningful Use Rule.

How do you plan to use this data? Email us your ideas at ComplianceSolutions@usdm.com.

**The world's largest biomedical library, the National Library of Medicine maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development and training in biomedical informatics and health information technology.