July 6, 2015

FDA Gives MDDS World a Big Break

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Sometimes it’s nice to be told what the FDA isnt going to do. The agency issued a guidance last month that should give anyone building or working with a Medical Device Data System (MDDS) happy and relieved. Can you hear the collective sigh?

FDA defines MDDS as any hardware or software that transfers, stores, converts, and or/displays medical device data. To be considered MDDS, the product cannot modify either the data or its display. It also cannot, by itself, control the functions of a medical device. MDDS is not supposed to be used for active patient monitoring. FDA’s MDDS examples include:

  • software that stores patient data such as blood pressure readings for review at a later time;
  • software that converts digital data generated by a pulse oximeter into a format that can be printed; and
  • software that displays a previously stored electrocardiogram for a particular patient.

FDA logoThe February 9 guidance, building on a June 2014 draft document, advises manufactures, distributors and others involved that it “does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.” Industry should thank the FDA for acknowledging the low-risk nature of such devices. Further, the agency cited the “importance they play in advancing digital health.”

Specifically, the agency is giving out three free passes: MDDS previously subject to 21 CFR 880.6310, medical image storage devices previously subject to 21 CFR 892.2010, and medical image communications previously devices subject to 21 CFR 892.2020.

Comments, or applause, can be sent to the agency at www.regulations.gov. Cite document number 140021. The agency does point out, however, that comments may not be acted upon until the document is next revised or updated.

Stuck for a comment idea? Well, flowers are always nice. People love those big tins of caramel popcorn, too.

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FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and Radiological Health (CDRH) says in its latest stats. It’s not sure why, exactly, but posits it’s due to an increase in inspections overseas. That drains away resources for domestic doings.

It’s worth noting that the overall number of inspectional observations dropped by 17 percent in FDA’s latest stats from 2013. FDA’s most frequent inspectional observations remained consistent, with Corrective and preventive action procedures (CAPA) leading the way, followed by complaint reviewing, receiving and evaluating. The trio was rounded out by problems with quality audits to assure quality systems are in compliance. Not much new there. Still, it’s important to know.

For the first time since 2009, the number of warning letters issued by CDRH dropped according to the agency’s most recent annual stats. Fewer than 5% of domestic firms and over 15% of foreign firms inspected received warning letters. That might sound good to US-based device makers, but as manufacturing moves more and more overseas, those higher stats are becoming their problem, too.

FDAlogoUntil we receive more recent numbers, we’ll have to look for anecdotal evidence suggesting any deviation in the FDA’s regulatory focus in 2014 or 2015. So far, it’s looking like business as usual.

Let’s take a quick look at some recent warning letters to better illustrate the point:

While FDA’s overseas inspections have tended to focus on India and China, CDRH hit Spanish-based DIMA, a manufacturer of slings and incontinence mesh products, with a warning letter for insufficient environmental controls and other good manufacturing practice (GMP) shortcomings. CDRH hit the form for not having change handling procedures that were up to the mark, and failure to demonstrate that a CAPA it opened ultimately did not require corrective actions.

Back in Tonawanda NY, CDRH’s January 23 warning letter to Praxair criticized the firm for not having clear definitions for what qualified as a reportable event. Further, the agency said the company did not require verification of validation of CAPAs. Praxair makes gas flow products that regulate oxygen flow.

Related:

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters and Quality System Deficiencies

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Quality Takes Time, FDA’s CDER Reminds Drug Makers

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D.. The Great Pyramid of Giza took about twenty years to construct, according to ancient historians, but it must be remembered that Egypt’s rulers were pretty rough on their non-volunteer workforce. Deadlines had a deeper meaning back then.

By contrast, the Center for Drug Evaluation and Research (CDER) quality initiative has been with us some ten years, or about the time it took to build the Panama Canal. Both projects have had to dig through – and around – a lot of muck. At the peak of work, excavators in Panama carved out the equivalent of the English Channel Tunnel every 14 weeks. It’s not fair to hold the agency to that same standard.

Pharmaceutical manufacturingInstead, let’s acknowledge that FDA just completed its own new structure called the Office of Pharmaceutical Quality (OPQ). Less bricks and mortar than a shift in human capital, the OPQ will take on some of the functions and staff at the Office of Pharmaceutical Science (OPS), take some preapproval and surveillance inspections duties from the Office of Compliance (OC), and absorb some of the inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations. The idea is to make the drug review more integrated with FDA and improve communications both ways.

The agency hopes OPQ will streamline the processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

OPQ was built, in part, in response to the falling number of drug-related product recalls over the past few years. FDA believes OPQ will help it better organize and quantify the state of manufacturing at drug facilities in the US and abroad. FDA’s recently been pushing a new approach to quality metrics, as highlighted by CDER’s Russell Wesdyk. His presentation outlines CDER’s revised way of looking at surveillance and adoption of quality metrics that promote the use of a common language to improve measurement.

According to Wesdyk, quality metrics will be used to assist segment sites and producers based on risk when it comes to inspection and reviews. But it won’t issue “restaurant style grades” reporting how one facility stacks up against industry groupings. Wesdyk encourages any interested parties to reach out to him as FDA’s thinking evolves. That’s a good thing.

Remember, it’s not as if the Panama Canal doesn’t require some maintenance now and then. The FDA’s got the right idea here.

The alternative is to build something and then forget about it. We’ve all seen how that usually turns out.  Take a look at the Pyramid of Giza lately?

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FDA’s CDRH Tempers 2015 Goals with a Dash of Pessimism

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

Unlike its sister Center for Drug Evaluation & Research  (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds industry not to get its hopes up too high.  “Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of guidance documents it undertakes,” it admits toward the front of the new document. CDER emerges as the more world-weary older sibling, optimism tempered a bit by experience in the real world.

FDAlogoThe agency’s priorities guidance lists keep it pretty simple: the A-list are guidance’s it “fully intends” to publish. The B-list are ones it will publish “as resources permit.”  CDRH reminds us that if we weigh in heavily on a particular guidance, it’s always possible the Center will move it up the waiting list.

They list just over a dozen final guidance topics and draft guidance topics on their A-list, as it were. Those include:

  • Applying Human Factors and Usability to Optimize Medical Device Design
  • 510(k) Submissions for Medical Devices that Include Antimicrobial Agents
  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Market Approval
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

A-list draft guidance topics include:

  • Medical Device Accessories
  • Medical Device Decision Support Software
  • Benefit-Risk Factors to Consider When Reviewing IDE Submissions
  • Adaptive Design for Medical Device Clinical Studies
  • UDI FAQs.

The B-list is shorter. The only Final Guidance Topic it holds is one finalizing existing draft guidance documents (see above).

It does include some draft guidance topics we might see in 2015, though it’s not so likely given CDRH’s workload. Here are a few:

  • Medical Device Interoperability
  • 3D Printing
  • Use of Symbols in Labeling

CDRH further lists some two dozen retrospective guidances it is due to review in 2015. Those mostly focus on specific guidance for various 501(k) premarket notifications, e.g., short-term and long-term intravascular catheters, electromyography needle electrodes, and powered tables and multifunctional physical therapy tables.

All in all, CDRH is to be applauded to laying out what looks to be a realistic wish list for 2015. Of course, the proof’s in the pudding. We’ll report back as they hit various milestones.

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FDA’s CDER Unveils Ambitious 2015 Wish List

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.

CDER Director Janet Woodcock recently said these are her agencies “front burner” priorities:

  • Implementing and clarifying statutory provisions on drug compounding.
  • Meeting Generic Drug User Fee Amendments (GDUFA) review goals that went into effect Oct. 1 last year.
  • Continue the build out of Office of Generic Drugs “super office.”
  • Build out the Office of Pharmaceutical Quality.
  • Implement and continue to develop Program Alignment Group agreements with the Office of Regulatory Affairs.

She singled out the implementation of a new process, data and document management IT system as a “big deal” goal this year

But there’s plenty more on FDA’s big front burner:

  • Respond as needed and participate in “21st Century Cures” legislative activities.
  • Rapidly re-evaluate regulation of drug advertising and promotion.
  • Execute immediate actions required by the Sunscreen Innovation Act and implement a longer-term plan.
  • Respond to Ebola outbreak.
  • Issue final guidances on abuse-deterrent opioid formulations.

She’s also hoping to fill more than 600 staff vacancies and recruit for a slew of executive positions.

prescription drugsWoodcock’s ambitious goals include five more bulleted pages of additional “important” priorities ranging from implementing a biosimiliars program, working on the Drug Label Improvement Initiative and developing a strategic plan for managing a growing pile of drug imports.

In the agency’s spare time, the plan is to issue nearly fifty guidances in advertising, biopharmaceuticals, biosimiliars, clinical medical/pharmacology/statistical/drug safety, electronic submissions, generics, and labeling, among others. Each of these guidances are already under development, CDER said earlier this month.

It’s certainly important to have goals, and a person’s reach should exceed their grasp, etc, but there’s also the problem of over-promising and under-delivering.

FDA’s got a big front burner but maybe not enough cooks, or oven space, to get it all done in 2015. We’ll keep an eye on it and report back throughout the year. Bon appetit.

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FDA Update on UDI Implementation for Registered Medical Device Establishments

In case you missed it, the FDA issued this update on UDI yesterday:

Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA’s Center for Devices and Radiological Health (CDRH) would like to take this opportunity to summarize recent and upcoming UDI activities and deadlines. The next two compliance dates for UDI requirements are:

September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices

September 24, 2016 for class II devices

Global Unique Device Identification Database (GUDID) Data Submission:

FDAlogoIn January 2015, we will begin accepting GUDID account requests from labelers of I/LS/LS devices. Later in 2015, we plan to accept GUDID account requests from labelers of class II devices. We strongly encourage all device labelers to take steps to ensure their readiness to meet UDI requirements well before actual data submission to GUDID. This will provide labelers with ample opportunity to assess their ability to meet requirements, including data submission to the GUDID, by their deadline and to work with us if they have any difficulties coming into compliance. Suggested steps are included on the UDI website.

Also in January, we will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule. Notification of webinar specifics will be sent directly to these device labelers in early January. The webinar will include overviews of UDI requirements and how to get started with the GUDID.

UDI Policy:

We continue to work with industry on UDI implementation issues that surfaced in 2014, including GUDID data submission for contact lenses/IOLs and development of approaches to ensure the UDI is available at the point of use for non-sterile implants. We recognize there are several other policy issues that are of significant interest to industry; we hope to address a number them in 2015, such as UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).

The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with thecompliance dates for UDI requirements. Device labelers that want to retain the use of FDA-issued NHRIC or NDC labeler codes under a system for the issuance of UDIs were required to request such continued use by September 24, 2014. If you intend to retain the use of a previously issued FDA labeler code within your UDI system but have not made such a request, we urge you to do so as soon as possible.

UDI Adoption and Use:

We continue to collaborate with stakeholders, such as the Pew Charitable Trusts, the Office of the National Coordinator for Health IT (ONC), and the Brookings Institution to promote and facilitate UDI adoption in health care settings.

We are working with the National Library of Medicine (NLM) to give the public search and download access to published records in the GUDID in the spring of 2015. GUDID search will allow published GUDID data to be retrieved based on parameters of interest to the user. The GUDID download function will let users download all published GUDID data at once.

Finally, we’d like to reaffirm our plans to implement this important system over several years—and underscore the fact that we fully intend to be flexible during this time. Our main focus is getting the system implemented correctly and actively helping companies comply with system requirements. As with the implementation of many new systems, it can take time to understand and comply with new requirements—widespread, strict enforcement of associated deadlines and requirements is not necessarily the best way to achieve compliance at this time.

To date, industry has been very willing to work with CDRH, and we have experienced excellent efforts and strong feedback. We urge labelers that are having difficulty fulfilling UDI requirements to let us know through the FDA UDI Help Desk.

We will continue to work diligently to give the medical device industry, health care systems, clinicians and patients the assistance and information needed to implement and use UDI successfully. For additional information, please see www.fda.gov/udi or contact us at the FDA UDI Help Desk.

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Got Safe Beef? New Report Suggests the US Doesn’t

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

Almost across the board, the US ranks at the bottom (“regressive”) for produce traceability programs as ranked by a new Institute of Food Technologists (IFT) report.

IFT checked out 21 countries and rated them “Progressive,” “Moderate,” or “Regressive” based on a handful of criteria.

While the landmark Food Safety Modernization Act of 2010 (FSMA) is expected to improve things here in America, “development of regulations are still in the early stages,” the study noted. Technically, the study is called “Comparison of Global Food Traceability Regulations and Requirements.” That’s quite a mouthful, pun intended. An earlier IFT powerpoint presentation also examined this important issue.

FSMA was signed into law by President Obama on January 4, 2011. FSMA was designed to give the Food and Drug Administration (FDA) new power to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new tools, the most important of which is mandatory recall authority. But that’s all in the future. The IFT report tells us what’s going on right now.

Where to start when reading the report? The ranking of 21 countries (EU, China, Japan and a few elsewhere including Brazil and the land of the Kiwis) found that the US was only one of two major beef exporters without mandatory red-meat traceability systems. It also lagged behind most of the group with a weak consumer access program.

Generally, countries in the EU (France, UK, Germany, Ireland et al) led the group. That’s thanks, in part, to tough standards imposed in 2005 that include mandatory traceability programs for food, feed, food-producing animals and any other substance incorporated into food or feed.

livestockBlog

The US did achieve some distinctions — pretty much all bad. For example, it joined China as the only countries rated regressive when it comes to the breadth of products regulatory traceability regulations.

The US, China and Canada are also the only members of another not-so-attractive-club: Regressive electronic livestock traceability programs.

In its summary, the report diplomatically notes the obvious: The US “trails most other nations.”

Let’s wrap this up on something of a positive note.The US did make the top category for voluntary traceability programs. An optimist might say US meat exporters are significantly exceeding their nation’s relatively lax regulatory requirements. Pessimists might still urge you to think twice before buying that next cheeseburger, chicken sandwich, or tilapia in America — at least until the FSMA kicks in.

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Are You Ready for 21st Century eMDR Submissions?

Jeff Mazik

Jeff Mazik, Vice President, Life Science Solutions, AssurX

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting. Although not much has changed in this final rule in regard either to required content, the submission process, or submission timelines, the FDA has taken a large step closer to mandating 21st century technology. The final rule states that all required adverse events are to be submitted electronically by August 14, 2015.   The clock continues to tick…

Not sure if you’re handling this new reality properly? Well, here’s a quick way to find out.

Are you (or your management) making any of these statements:

“The FDA always delays, we will just wait and see.”

FDA has shown no indications of changing or extending this electronic submission requirement timeline. Their hardline stance is mostly due to the fact that electronic submissions of the MedWatch form via electronic means (through their ESG) has been available for many years on a voluntary basis. Numerous manufacturers have taken advantage of this technology over the last number of years to streamline adverse event reporting. Soon, the electronic submission process for these reports becomes mandatory.

We don’t submit a lot of complaints, we will just wait until we have something to report.”

Maybe your company does not have many adverse events to report…maybe only once in a blue moon (great for you!). However, if you wait until a complaint occurs (after August 14, 2015), and the complaint results in a reportable event that requires submission, you are caught in a very dangerous game of Russian roulette. You see, an electronic account is required to be set up prior to an eMDR submission. FDA has previously stated that the setup of an account takes between two-to-six weeks (not counting the form completion process and ensuring all was filled out correctly). Now, depending on the adverse event, you will have between five to 30 days to officially submit it to the FDA, electronically. With a two to six-week wait on an account, you will be caught in a waiting game that in all likelihood will make you non-compliant. That’s not a good place to be.

Don’t get caught in this game where you are most likely going to lose. There are options available to do this submission electronically in a secure, managed, workflow driven environment.

“Ok, Im convinced, what options do I have for submitting electronically?”

If you already submit your adverse events to the FDA electronically, there is nothing you need to change. However, if you do not and are still submitting via paper/PDF, now is the time to start investigating your options. Although the FDA provides the eSubmitter tool to help you submit the reports electronically, it does not integrate with your electronic quality management system, provide electronic signature approvals, a workflow process, KPI measurements, or the like. In many cases users will be required to re-key or copy/paste data from their original source. This error prone, non-integrated solution leaves much to be desired, but it does serve as a quick and easy way to submit the completed report.

eMDR

AssurX eMDR Process

A better, more integrated business model is available, however. AssurX, a leading EQMS provider, has for many years offered a low cost standalone eMDR electronic submission solution. Furthermore, it can optionally be fully integrated into a complaints management workflow solution for your business, providing electronic reviews and approvals, tracking tasks, generating email notification and escalations, as well as identifying trends and tracking key performance indicators for your business. Either of these AssurX solutions can be implemented on premise, or in a privately hosted “cloud” solution that allows you to implement more quickly and with lower start-up costs.

It’s time. Get started now.

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Report: Medical Device Approval Still Lags, but FDA is Trying

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit, says an interesting new report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).

In hindsight, it appears FDA hit a bottom in 2010 when approval times averaged a staggering four years longer in the US than Europe. Those delays, the report argues, kept proven, life-saving technologies from American patients unless they traveled abroad. Worse, there’s no evidence the FDA’s snail-like approach to approvals made products used in the US any more effective or safe.

Congress and the FDA came together in 2012 to try and find ways to implement, and fund, new policies designed to improve regulatory clarity, consistency and predictability. Industry agreed to pay significantly higher users fees to help make it happen. The new approach was collected in the Medical Device User Fee Amendments of 2012 (MDUFA III).

The verdict? “Real improvements are evident, yet there are still areas of concern.”

It’s worth noting that CHI and BCG applaud the Center for Devices and Radiological Health (CDRH) for working hard to “get processes, internally and with industry, back on track.”

FDAlogoThere’s some good evidence out there to support industry optimism. Report data suggests that, after a 2010 nadir, the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era. Early returns for 2013 show even further improvement, though the study cautions that there are simply too many products awaiting a decision to make rock-solid claims just yet.

If PMA is part of the good news, the weather report in 510(k) land is far less sunny. Review times in 2012 were 60 percent longer than 2000, say CHI and BCG. But unlike the relative success with PMAs, today’s 510(k) review times “continue to remain far higher, and processes are still viewed as less predictable, than during the pre-device user fee era,” according to the report, Taking the Pulse of Medical Device Regulation & Innovation.

Another disheartening finding: The lag between FDA approval and faster action in Europe hasn’t changed much so far. Europe’s regulatory environment continues to lure US medical technology business away. “Only time will tell if recent improvements at the FDA ultimately have any impact on this gap,” the report summarizes.

Back in my elementary school days, most teachers took great pains to encourage a student who was genuinely trying — even if the results were not always so great. Maybe we should give the FDA a hearty pat on the back instead of a kick in the rear. It just might work.

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FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

The Food and Drug Administration (FDA) reported that there have been over 240 user accounts setup in the agency’s Global Unique Identifier Database (“GUDID”) since the rule’s effectiveness date, and from those accounts there have been over 33,000 Device Identification numbers entered into the GUDID. This was identified as a very good start by agency personnel at the 6th Annual UDI conference this week in Baltimore.

The deadline for all Class III Medical Device manufacturers has now passed and the agency thanked those that have worked so hard to get in compliance by last month’s due date. It also shared updates and lessons learned over the last 13 months since the rule was finalized and released.

The clock now starts ticking for manufacturers (FDA uses the term “labelers”) of Class II devices that are implants, life sustaining or life supporting in nature. These labelers must complete their UDI implementation and enter their Device information into the FDA’s GUDID by September 24, 2015.

FDAlogoHowever, FDA said that the labelers of these Class II life sustaining/supporting devices will not be granted user accounts until January of 2015, at the earliest. This does not mean that this group of manufacturers should stand around doing nothing, though. There are many preparatory and investigatory activities that this group should begin actively moving forward on. Some of these activities include developing a project team, reviewing current labeling processes and artwork, identifying/obtaining a DUNS number (if one is not currently defined for the labeler), and most importantly, ensuring upper management is aware and fully supports the UDI initiative in their organization in order to drive internal commitment and resources.

Attendees also were informed that all other Class II devices must be in compliance by Sept 24, 2016, and all Class I devices by Sept 24, 2018. Unfortunately, if the current practice remains in effect, those labelers in these other two groups will not be given account access to do any submissions until late 2015 or early 2016. For now, the FDA will focus only on Class III and Class II implants/Life Sustaining/Life Supporting labelers.

Other topics during the conference included recaps of the UDI Rule and GUDID system. One interesting update: the FDA’s UDI web interface will no longer be made available to the public/healthcare workers for directly accessing and searching the GUDID for medical device information. FDA’s UDI group has recently partnered with the National Library of Medicine, and will be integrating the GUDID with the NLM’s online system for public searches, database downloads, and web service access of medical device information stored in the GUDID. This will reportedly be available 1st Quarter of 2015.

Although the first phase of UDI compliance with Class III labelers has been deemed successful, it was reported that there have been several dozen extensions provided to members of this group. However, the FDA hasn’t said if extensions will be granted to Class II or Class I labelers, as well. So, if you haven’t already, it is in your best interest to start your UDI project soon.

If you are interested in seeing a low-cost solution for UDI record management that provides electronic submissions to the GUDID, and integration to other quality processes, such as complaints management, please request a demonstration.

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