September 19, 2014

The Six C’s of Document Management Best Practices for Life Sciences

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Implementing a best practice solution for any quality process is essential to help an emerging Life Science company insure compliance and quality for their organization.  Especially when it comes to Document Management, regulatory agencies in the Life Science industries expect that your company has proper controls in place that insure the documents you are using have been properly authored, reviewed and approved and that your staff have been adequately trained on them and, of course, can easily access and use the effective documents at all times.  As documents are truly the backbone of all of your quality processes, this is indeed appropriate.  For if your documents are not controlled, neither will be your processes.

Utilizing an electronic Document Management System is the first step.  A workflow and task-based electronic system can provide you with a central repository for all documents and gives you the potential to implement an infrastructure that allows for much more control and interoperability than if you try to manage documents manually or on a server file share.  Some advantages of using a workflow based process include activity reminders for those tasked to do work, automated activities and notifications, virtual collaborations, metrics tracking, and providing overall increased control and visibility.

electronic document managementMany start-ups and emerging companies in the Life Science industries are constrained in a number of ways, particularly in funds and resources.  This can present many hurdles in trying to get a useful Document Management System in place.  In order to minimize costs and expending copious resources, some options to consider include: selecting a solution that can effectively address multiple business or quality needs to increase ROI, a solution that provides a lower cost option of hosting off-site (e.g. Cloud based solution), one that utilizes non-proprietary infrastructures, and one that can be configured without requiring programming resources.

A best practice approach for implementing an electronic Document Management system can be summed up into “Six C’s”.  These six terms help identify the areas that should be addressed when implementing an electronic Document Management system.  The Six C’s are:

Consistency:  Use the system as a central repository for all documents, implementing consistent workflow path(s) for documents depending on document type.  Use consistent Document Templates and standardize attributes (e.g. approvers, periodic review timelines) for similar document types.

Communication: Information must be easily available to your staff throughout the
workflow process, allowing virtual collaboration no matter where the team is located.  Furthermore, those people in this document review/approval process that are assigned tasks must be provided communication and follow-up reminders to insure their tasks are being completed on-time and never “fall through the cracks”.  Finally, notifications of new and revised documents must be communicated effectively to the training organization to insure requirement employee training is accomplished.

Client experience: The electronic system should incorporate end-user functionality that increases performance and acceptance such as: including built-in instructions within the process itself as well as visual hints or cues that make it obvious to the user where the document is in the process and what to do next.  Also, provide varied search functionalities and options that allow users to easily find documents they need.  Plus, automate as many activities as possible, especially those that can be easily forgotten by a user, causing re-work.  

Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures.  Control of the “original” electronic document files themselves is also an important concept.  Insuring there is no back-door to access/change documents at a file server level or shared folder perspective is very important.

Compliance: The electronic system must meet all applicable regulatory requirements (e.g. 21 CFR Part 11).  Also, implementing reminders and escalations when tasks are due (or late!) helps you to stay in compliance to objectives and agreed upon timelines.  Furthermore, by implementing an effective integration with a training management system allows you to stay compliant with employee training requirements.

Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.

If you are interested in getting more detailed information on the Six C’s of Document Management Best Practices please request to view our recent 60-minute “Life Science Best Practices for Document Management” Webinar here.

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Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

In 1908, the first Model T was created and more than 15 million were sold through mid-1927, proving that a focus on your core product can create a tidal wave of success. The plan and processes Henry Ford put in place to create the Model T, revolutionized the automotive industry. Having a streamlined set of processes is still important for manufacturing a quality product today. The Model T not only tells the story of efficiency and mass production, it also depicts the story of quality proving that they are not mutually exclusive.

The medical device industry is no doubt tough to do business in, whether it’s the constant threat from multiple competitors or the constant scrutiny from the FDA with 21 CFR Part 820 and Part 11, it’s an eat or get eaten world. Non-compliance with the FDA can result in a number of costly consequences including audits, recalls, production stoppage, substantial fines and potential lawsuits.

With the advancements of technology we are now able to efficiently control and monitor the process with tools such as an Enterprise Resource Planning (ERP) system combined with a Quality Management System (QMS). Having the right partnership between your ERP and QMS vendors allows you to create a reliable support system.

erp/qmsimage

With such a support system in place your company can in turn focus more on your initial quality system, developing a sound and innovative product. The theory being that creating a quality product begins with the inception of the product. A house built on sand, no matter how nice it looks, is not going to work, and the same goes for a medical device, a quality product should be the goal from the very beginning. With today’s tools Henry Ford could create the ultimate formula: efficiency + variety + quality = success

A more detailed paper, Effective Compliance Programs Demand Sound Strategy, Strong Partners written by Michael Causey, outlines some of the key advantages your company stands to gain by selecting and ERP system that is integrated with your QMS. The never-ending challenge of creating and monitoring a quality system can contribute to your company’s increased regulatory compliance and customer satisfaction.

Get the full detailed White Paper here

About the Authors

Dennis Payton is Vice President of product marketing and development with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

Ryan Hussey is a marketing professional with Expandable Software, Inc. Mr. Hussey holds a BS of Business Marketing from San Jose State University and contributes personal time to coaching youth swimming classes and teams at local South Bay Area swim clubs.

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Medical Device Industry Endures Tough 2013; 2014 Prospects Not Much Better

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s March, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing last year, which could slow product innovation down the line, a drop in 2013 product approvals, and a mixed report on how that medical device excise tax thing is impacting hiring and other initiatives.

Let’s start with taxes. Studies from the Emergo Group, AdvaMed, and comments from the Medical Imaging & Technology Alliance (MITA) paint slightly different pictures, though none says the tax is good for the industry — the reaction has ranged from sort of bad to really bad.

Emergo’s survey, which has been criticized by MITA but endorsed by AdvaMed, said effects weren’t good, but weren’t as bad as predicted. In 2013, 75% of respondents said the tax would result in major (read: bad) changes in their business. But fewer than half said it had actually gone down that way in a similar Emergo study this year.

AdvaMed, which has applauded some recent efforts to repeal the device tax, saw a bleaker picture. Nearly 40 member companies reported that the tax forced 14,000 layoffs, and big reductions in R&D and start-up company investment.

That last bit is troubling — and may be with us for awhile.

downward trend

A recent survey by EP Vantage (EP) found 2013 to be one of the worst on record in terms of mergers and financing activity which “could contribute to a lack of innovative devices in future.”

The recent past doesn’t look so hot, either, according to EP. Last year, the FDA approved just 23 innovative devices, that’s down 44% from 2012.

“The increasingly stringent FDA approval process means that devices tend to gain European approval around three to five years before they reach the US market.” But wait, the bad news gets worse. Proposed changes in the EU approval system might throw a spanner in the works there, too, EP warns.

Still, there’s a potential silver lining: If EU approval gets significantly tougher, it could put pressure on the FDA to continue efforts to speed things back in the 50 states. “To its credit, FDA is aware of this [potential EU approval slowdown] and is weighing options to combat it [including] the new de novo pathway, a swifter review process for low-risk devices intended for unmet needs.”

FDA weighing some changes is good news for the device industry. Until then, its the medical device industry struggling under the increasingly heavy burden.

 

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The Six C’s of Complaints Management Best Practices for Life Sciences

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements for a number of regulatory agencies. Chief among these are requirements from the FDA, as well as from ISO, plus they must meet expectations from a number of other regulatory agencies, depending on the particular market. Implementing best practice solutions for a company’s quality processes is essential to insure compliance and quality for the organization.

When it comes to Complaints Management, a best practice approach can be summed up into the Six C’s of Complaints Management. These six terms help identify the areas that need to be addressed when initiating a best practice complaints management system.

The Six C’s are:

Collection: Collect as much information at intake of the complaint as possible. This is a major customer “touch point” in the complaints resolution process, so don’t waste it. Furthermore, the collection of incoming complaints must be reviewed to determine if the communication is truly a complaint. Depending on the determination of that review, handle the situation accordingly.

complaintConsistency: Incoming complaints must be recorded with consistency in the information collected. To help facilitate this, questions to ask the customer must be designed to be consistent across similar events, allowing for accurate trending of product problems. Also, steps taken downstream in resolving the complaints process should be guided by providing consistent information to all people in the complaint resolution process.

Communication: Information collected during intake and throughout the process must be easily available to everyone in the complaint resolution process. Furthermore, those people in the complaints resolution process that are assigned tasks must be provided communication and reminders to insure their tasks are being completed on-time and never “fall through the cracks”. From a customer satisfaction perspective, the customer reporting the event must be informed of the status of the complaint using form letters or via online queries using a web portal.

Compliance: The electronic system must meet all applicable regulatory requirements. Furthermore, a consistent approach must be used to determine how soon complaints should be reported to the applicable regulatory agency.

Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures. However, controlling one’s business in terms of allocating available resources, trending historical complaint attributes, and proper management of returned products is also essential for the business to succeed.

Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.

If you are interested in getting more detailed information on the Six C’s of Complaints Management Best Practices please request to view our recent 60-minute “Life Science Best Practices for Handling Complaints” Webinar here.

 

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CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate

Tamar June

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

The Center for Devices and Radiological Health (CDRH) will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 Strategic Priorities report released Feb. 5.

To help encourage that innovation, CDRH says it’s going to work to improve the consistency of the Investigational Device Exemption (IDE) process, especially in the areas of consistency and speed with which it handles applications. CDRH also pledges to find ways to encourage more early IDE studies — especially for those with medical devices aimed at the U.S. patient marketplace.

The report also says CDRH will try to find a better balance between premarket and postmarket data requirements.

CDRH sets measurable metric goals for improving IDE cycles:

  • By September 30, 2014, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25 percent compared to FY 2013 performance.
  • By September 30, 2014, for disapproved IDEs, offer all sponsors a teleconference or in-person meeting to occur within 10 business days of the IDE decision.
  • By June 30, 2015, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50 percent compared to FY 2013 performance.

Time to IDE Approval:

  • By September 30, 2014, reduce the overall median time to appropriate full IDE approval by 25 percent compared to FY 2013 performance.
  • By June 30, 2015, reduce the overall median time to full appropriate IDE approval to 30 days.
  • In FY 2013 (as of 12/11/2013), 45% of IDEs received a full approval decision within 2 cycles and median time to full IDE approval was 174 days.

2014 ClockBy June 30, 2015, the report says CDRH intends to increase the number of early feasibility/first-in-human IDE studies submitted to each premarket division compared to FY 2013 performance. CDRH promises several action steps here, including:

  • Establish in the Office of Device Evaluation a premarket clinical trials program responsible for the oversight and performance of the IDE Program and the development and implementation of policies that contribute to the timely initiation and successful execution of medical device clinical trials.
  • Formalize the incorporation of our benefit-risk framework, including patient-specific factors such as tolerance for risk and perspective on benefit, into the IDE process.
  • Establish a process to efficiently and objectively resolve application-specific IDE issues to reduce the number of multi-cycle IDEs.
  • Develop a clinical trials education and training program for CDRH review staff, managers, and industry.
  • Develop real-time metrics to track CDRH and industry IDE and clinical trial performance.

Turning to premarket and postmarket data requirements, the CDRH call to arms lays down more goals:

  • By December 31, 2014, review 50 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By June 30, 2015, review 75 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By December 31, 2015, review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.

CDRH plans several specific actions to help attain those targets, including:

  • Develop and seek public comment on a framework for when it is appropriate to shift premarket data collection to the postmarket setting.
  • Conduct a retrospective review of all PMA device types to determine whether or not to shift some premarket data requirements to the postmarket setting or to down classify device types in light of our current understanding of the technology.
  • Implement a mechanism to prospectively assure the appropriate balance of premarket and postmarket data requirements for new devices subject to a PMA.
  • Using existing authorities, develop and seek public comment on a new pathway to market for devices subject to a PMA that address an unmet public health need by shifting appropriate premarket data needs to the postmarket setting and incorporating features of the Innovation Pathway pilots.

The medical device industry no doubt applauds the majority of these goals. Now it’s time for CDRH to roll up its sleeves and get them done.

 

 

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Medical Device Makers Urged to Play Nicer by Sharing Data

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes.

The Institute of Medicine (IOM), already working with more than a dozen drugmakers, the FDA and the National Institutes of Health (NIH), wants to see a little more enthusiasm from the medical device community when it comes to data sharing in device clinical trials. To be fair, this requires some delicate balance: Everyone wants to advance the public health, but it’s not fair to expect a drug or device company to just give away all of its hard-earned, costly proprietary data, either.

IOM understands that, it appears. Yet the medical device industry won’t be doing itself any favors by trying to ignore this issue. Beside the bad PR hit the industry could take, what happens if the FDA

info

decides to just swoop in and impose something on industry? The drug folks have had their input; the medical device industry would be well advised to speak up, too.

Industry and anyone else with interest in the issue has a few ways to get involved. Comments on IOM’s proposed framework for getting this right can be sent here until March 24.

For those in the area or looking for a nice trip, there are also two open workshops in Washington D.C. on Feb. 3-4 and May 5.

Seems like the medical device industry has a clear choice here. Speak up now, or don’t complain later.

Reminds me of another useful slogan: Silence is consent.

IOM’s proposed framework is can be found here.

Info on the public workshops is here.

 

 

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Analysis: No Need For State of the Union Analysis

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Those of us in and around Washington D.C. like to tell folks leading up to a president’s State of the Union (SOTU) address that the speeches rarely matter and are generally forgotten while the teleprompter’s still warm.

Then we analyze them to death for a few days. I don’t mean to sound cynical, but it does tend to help cable TV ratings and maybe even sell a few of those funny flat things called newspapers.

First, a little perspective might be in order. The good folks at the History Channel remind us that most SOTUs are remembered for reasons less to do with policy and more to do with current events. They point out that Harry Truman’s SOTU was kind of a big deal because…it was the first ever televised. Bill Clinton’s second was also a big deal…because everyone wanted to hear if he’d resign because of Monica Lewinsky and her blue dress.

President’s Reagan and Bush II delivered memorable SOTUs, among others, but in both cases they came after significant events — the Reagan assassination attempt, and 9/11, respectively — and they will probably be remembered more for emotional and not policy reasons.

Still, if CNN, MSNBC, FOX and everyone else can breathlessly analyze them seconds after they’re delivered, why not do it here from a medical device perspective.

It might be interesting to start with something President Obama didn’t talk about in his 2014 address: The Medical Device Excise Tax. It’s still out there, and its prospects of becoming the law of the land have ebbed and flowed over the past year, but the President chose not to bring that one up.

To be sure, the President did devote a lot of the SOTU to domestic issues including healthcare. However, that focus was mostly on the Affordable Health Care Act. That one’s not going away anytime soon, and we’re not going anywhere near that here today.

Now back to the SOTU and the medical device community.

state_of_the_unionSmart communications professionals who work for trade associations and private companies listen closely to the SOTU for anything, anything they can connect their industry to in order to get media coverage. This time, when President Obama spoke about the general need for innovation in this country, some saw the opportunity.

“The President is absolutely correct that investments in innovation will help the United States remain the global economic leader in the 21st century,” Medical Device Manufacturers Association (MDMA) President and CEO Mark Leahey said after the SOTU. “While there will be numerous debates on how we can improve our economy, there is widespread agreement that high tech job creation and reducing the cost of health care play a central role. Medical technology innovators have a proud tradition of meeting these important goals, but we cannot take for granted that this will always be the case.”

Meanwhile, the folks at the Advanced Medical Technology Association (AdvaMed) took a similar approach — but added a whack against the Medical Device Excise Tax in their response to the SOTU.

Its President, Stephen J. Ubl, commended the other President, “AdvaMed applauds the President’s support for the growth of high technology manufacturing jobs and the importance of innovation to economic growth in [Obama's] State of the Union.

“In support of that goal, we urge Congress to act promptly to repeal the medical device excise tax. America’s medical technology companies are leading the world in the development of innovative, life-saving, life-enhancing medical progress – but that lead is eroding. Repealing the medical device tax would support the bipartisan goal of helping companies large and small reinvest in R&D, hiring or expanding.”

President Obama didn’t mention medical devices specifically anywhere in the speech, but what the heck. SOTU’s rarely mean as much as we in the media like to tell you, remember?

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Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea.

It gets a little trickier after that.

In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen others, generally voice support for the UDI concept, while finding lots and lots to say about where the FDA’s September Draft Guidance could use improvement.

Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the length and complexity of the implementation plan demands a “living document” approach that will allow industry and the FDA to update and improve the guidance as both sides learn more during set-up. AdvaMed follows with 61 specific comments, with suggested changes.

Coviden, manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments, and tosses another 22 into the mix, including a request that the guidance remain open for feedback and comment until the September 24, 2014 implementation deadline.

Merck, among other commenters, requested clarification and summarization regarding the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also asked FDA to add information regarding deadlines for submitting data to GUDID.

X-ray of hipBoston Scientific, noting that its medical devices already bear unique identification via HIBCC or GS1 standards, calls FDA out for what it labels “inconsistencies” with the FDA UDI Rule.

To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims the data elements column “Required?” is unclear because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance.”

FDA’s got its work cut out for it here, particularly with the recent departure of its UDI guru, Jay Crowley, for the greener fields of consultantdom.

We can offer some small consolation though: Crowley leads a webinar on UDI implementation from his new professional perch. Information is here:

 

Final UDI rule as published in Federal Register

FDA’s UDI page

Previous AssurX blog on UDI

The entire comment letter line-up is available here

 

 

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Interpreting the FDA View of Medical Device Design Controls

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Some of the shortest descriptions in the FDA CFR 21 Part 820 Quality System regulation are found in Sec. 820.30 and Sec. 820.40 totaling about a page of written language around Design Controls and Document Controls. However short, these two sections can be the most complex aspects of Medical Device controls when actual complying with the regulation. Fortunately, the FDA does give a bit more background to help a new medical device company understand these two key elements (see Medical Device Quality Systems Manual, A Small Entity Compliance Guide) but again with the detailed complexities, even those few pages of guidance (covered in section 9 Document and Change Control) fall short of coverage needed to understand the impact a company’s Medical Device Quality System. The good news is that there are some very good tools that can help mitigate these complexities and streamline controls. The bad news is that it still takes a very strong detailed and sustained effort to insure these complex controls are in place for continued success and compliance with regulation.

With a wide variety of Medical Device suppliers there comes a wide variety of processes, procedures and controls that are developed specific to a business and to the Medical Device(s) being produced. It is important to understand how the FDA tries to normalize a specific business to the regulation when auditing that business for Design Control compliance. Having a bit of understanding of their view will help make for a much smoother comparison, analogy and a much cleaner and successful audit of a company’s design processes.

A simplistic model can be derived from the 820.30 regulation that the FDA may use to assure design coverage and compliance of a device design and/or manufacture to the regulation. The design and development model can be graphically depicted and loosely linked to the regulation as follows:

FDA Design and Development Planning Model

Diagraming out the design flow is helpful in seeing a more detailed picture of the flow and validation and verification of a product against its intended use model and specifically important to the FDA that each and every stage of the process is well reviewed and documented.

Again, like the FDA regulation on Design Controls, this is a very short summary of complex processes, document definitions, controls and general management & approvals that there have been volumes of books written. The objective should be to have a very good understanding of how the FDA or other regulatory entity views the medical device controls such that a business can demonstrate how their particular controls map into the regulatory model. A logical analogy of a business’ design and development model should be able to map to the regulatory normalized base line model(s), in doing so, will result in smoother audits with a higher degree of success and hopefully (something the regulatory folks don’t really care about but as a business we all do) a lower expense/time in managing through the audit process.

A fuller descriptive paper outlines some key points in the development of a Medtech-specific design control with a product development process and how to maximize the use of enterprise level business tools that accelerate process, streamline audits and make for a much smoother compliance. The brief outline here is a key element to a more streamlined and smoother compliance with regulation keeping in mind not just the business drivers but also the FDA’s “normalized view” of design controls.

Get the full detailed White Paper here

About the Author

Dennis Payton is Vice President of Product Marketing and Development with Expandable Software Inc. He has 24 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

Copyright UBM Canon. Used by permission.

 

 

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FDA’s 2014 Promises Increased International Operations, Label Enforcement

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.

With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014:

1) CDRH’s Office of Compliance Reorganization: With the addition of a Division of International Compliance Operations, watch for the FDA to shift focus and some budget funds to increased inspection and audits of foreign device manufacturers, and increased crackdowns on promotional claims (see below). Steve Silverman, Office of Compliance Director, is making the public relations rounds of late with events at a trade shows and the like. He’s stressing that the new “look” OC will better harmonize and broaden enforcement efforts. We’ll keep an eye on this and report back.

FDAlogo2) Device Off-Label Enforcement: If the old expression “the past is prologue” holds true, device makers would be well advised to take a good hard look at any public claims they, or a surrogate such as a doctor at a trade show, make about the wonderful things its gizmo can or will do for patients. Between May 1, 2012 and April 30, 2013, CDRH averaged two letters per month hitting device makers for making claims outside their 510(l) clearance and making claims requiring additional data they didn’t provide, among other issues. Early anecdotal evidence suggests this trend of more focus and more warning letters will continue to climb in 2014. Again, we’ll keep an eye out.

3) UDI Finally: FDA issued the long-awaited Unique Device Identification (UDI) Final Rule in September. Its driving force and 27 year FDA veteran Jay Crowley, has since left the agency for a consulting gig. It remains to been seen what impact, if any, his departure will have on an issue that’s vexed industry and the agency for many moons. I can’t think Crowley leaving is any kind of net plus in terms of helping to fine-tune the rule. Time will tell. Then we’ll tell you.

I didn’t even factor in the possibility of more budget shenanigans in Washington, D.C. I’m a naive romantic, and I’m not going to go there until I have to.

Happy new year!

 

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