May 25, 2015

FDA’s Local Offices Flex Regulatory Muscle

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings.

As expected, FDA is shifting more and more of its regulatory focus toward Medical Device Reporting (MDR). In an October 1 letter, the agency’s Baltimore District Office hit Baltimore-based Electronic Development Labs for not having an MDR procedure. Bad idea.

The company may not have recovered very well, either. “The adequacy of your firm’s response dated November 20, 2013, cannot be determined at this time,” FDA’s warning letter said. “Your firm’s response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.” Electronic Develop makes the NervoScope.

The agency also gently encouraged the company to look into eMDR.

As we’ve noted before, FDA eMDR Final Rule requiring manufactures and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If a firm is not currently submitting reports electronically, FDA politely encourages it look into it on FDA’s web page devoted to eMDR.

The FDA demonstrated its ongoing interest in CAPA in an October 7 letter from its Los Angeles Office to Alpha Medical, a maker of angiographic balloon catheters.

warning640After Alpha tried to respond to a September inspection, FDA made it clear the reply needed some work. Example: “CAPA 104 was opened on January 10, 2013, concerning non-conformities regarding balloon extension air leaks. The CAPA report references multiple root causes for these leaks; however not all of these potential causes were analyzed and investigated.”

The agency went on, “Your records reference that personnel were retrained, but the corrective actions for which they were retrained were not documented. Additionally, this CAPA was closed on February 22, 2013 without documentation that an effectiveness check was performed.

In an October 10 letter from the Cincinnati District Office, local regulators challenged West Lake Enterprises, maker of medical gas pressure regulators and suction regulators, with CAPA and other violations, including installation that’s not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation. The company responded, and FDA came back with additional questions.

The Denver District Office joined in with an October 28 letter to Xanacare Technologies, maker of SimulCare II, a therapeutic lamp/nerve stimulator/massager. The agency hit them for several issues, including problematic design control, device history records (DHR) and complaint handling. As of late October, the agency said it had not received a response from Xanacare.

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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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FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After a flurry of activity, it’s been relatively quiet of late on the FDA warning letter front. But three device makers did get some bad news in recent weeks.

FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a make of Class III medical device Life Vest with a number of observations, including failure to document a corrective and preventative action program (CAPA), review, evaluate, and investigate complaints, adequately establish procedures for design validation, and develop, maintain, and implement electronic Medical Device Reports (eMDRs) to the agency.

The eMDR Final Rule requiring manufacturers and importers to submit eMDRs was published February 13, 2014. The requirements of this final rule will take effect August 14, 2015.

Zoll’s senior management was also singled out in the September 23 warning letter for being unable to provide records of adequate attendance at management review meetings in 2013 and this year.

Our west, FDA hit Mission Viejo CA-based Alpha Medical Instruments for CAPA and other violations. Alpha manufactures angiographic balloon catheters.

Corrective/Preventive Action Workflow  as illustrated by AssurXDigging deeper into Alpha’s alleged CAPA problems, FDA’s October 7 letter noted that the firm closed out an investigation without being able to produce documents proving it had conducted an effectiveness check. Additional product problems emerged after the CAPA was closed out. Alpha’s subsequent response was found wanting by the agency.

Alpha was also dinged for failure to establish procedures for reviewing, receiving and evaluating compliance by a formerly designated unit, among other issues.

It’s worth noting that, while industry sometimes complains that FDA inspectors are inconsistent in terms of focus and expectations, it’s pretty hard to say FDA isn’t sticking with its emphasis on CAPA issues.

Finally, FDA identified problems of a different sort at Powers Device Technologies Inc., a Del Ray FL-based manufacturer of the Pacifier Activated Lullaby. The firm was charged in a September 25 warning letter with making unapproved product modifications and marketing those supposed new benefits without agency review. It’s been marketing the product as FDA-approved when, in fact, the agency said it has not approved the product as now constituted. The company must respond later this month in writing to the FDA to address these and other observations.

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FDA Proposals Take a Fresh Look at Some Stale Food Issues

Tamar June

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

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tough law even tougher.

FSMA, signed into law in January 2011, is designed to tighten food safety regulations and shift the focus to a proactive mindset and away from FDA’s relatively reactive approach in years past. FDA has now proposed seven rules to implement FSMA. This new wave of proposed revisions target four areas: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier verification program.

The action follows FDA’s May announcement it was engaging in the rule-making and guidance development process required to establish the new prevention-oriented standards. FDA implementation teams have developed a slew of ideas for how the agency can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves advancing new public health prevention standards and implementing the strategic and risk-based industry oversight framework at the heart of FSMA.

In just part of what could go into effect next year, FDA calls for revisions to the foreign-supplier verification proposed rule. It aims to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

Arguably, one of the more important FDA proposals is a new call to develop current Good Manufacturing Practices (cGMPs) more applicable to the animal food industry, provide flexibility for a wider diversity in the types of animal food facilities, and establish standards for producing safe animal food.

foodsafety570However, human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or cGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage). That noted, further processing a by-product for use as animal food (e.g., drying, pelleting, heat treatment) would still require compliance with the preventive controls for animal food rule.

FDA’s new amendments would also make exemptions a bit clearer, and raise the requirements defining a “very small business.” To be considered tiny, a firm must post less than $2.5 million in total annual sales of animal food, adjusted for inflation. FDA expects that exemption to apply to just over 4,000 facilities.

The proposed rules also address some supplier issues. FDA wants new controls addressing those occasions when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.

If these new FDA proposals become the law of the land, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing, review of supplier’s records) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.

Industry and any other interested parties have some time to weigh in on the FDA’s proposals. The FDA will accept comments on the proposed revisions of the four proposed rules for 75 days starting next week (September 29) while continuing to review comments already received on the sections of the proposed rules that are going to change. The agency will consider all comments before issuing final rules sometime next year.

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FDA Guidance Advises Device Makers to Think About Home-Use

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device manufacturers would be well-advised to address any potential home-use products risk at the design state, says an August guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device. This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address then entire manufacturing process — and beyond. It covers environmental issues, user issues, design issues, human factors, labeling challenges, postmarket considerations, and the always fun human factor

Digging a little deeper into the guidance, FDA covers many layers of these topics, including:

  • Environmental considers such as location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure and storage.
  • User considerations such as physical location, sensor/perception requirements, plus cognitive and emotional product demand.
  • Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues and special emphasis of electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
  • Human factors ranging from user training to certifications.
  • Labeling issues including describing the basic handling of the device, how to dispose of it in an emergency, disposal, and hygienic maintenance.
  • Post-market considerations such as robust customer service and medical device reporting.

electronic document managementFDA’s Medical Device Reporting (MDR) regulation requires manufacturers to submit reports to the FDA whenever it becomes aware of information that reasonably suggests that a device it sells may have caused or contributed to a reportable death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable death or serious injury should it recur.

For the FDA Form 3500A, instructions for completing specific items on the form, and the coding manual see MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

For additional guidance on the MDR regulation and the reporting requirements refer to FDA’s guidance Medical Device Reporting for Manufacturers (March, 1997). FDA advises medical device manufacturers to also take a look at its draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).

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FDA Spreads Regulatory Love Nationwide

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter round-up.

Indiana-based Med-Mizer, manufacturer of AC powered, adjustable and bariatric hospital beds, was hit by FDA’s Detroit office with a 12-point letter dated July 21.

Among FDA’s accusations, Med-Miser failed to:

  • Establish procedures for reviewing and evaluating incoming complaints
  • Develop, conduct and control and monitor its production process
  • Establish and maintain design controls
  • Validate a manufacturing process
  • Ensure its products meet acceptance criteria

Ventilab LLC, a manufacturer of manual resuscitation bags based in Grand Rapids, was also dinged by the Detroit office for CAPA shortcomings, inadequate complaint management, and failing to establish an acceptable risk management plan.

warning640Moving east to the City of Brotherly Love, FDA’s Philadelphia District office sent a warning letter to the maker of a sleep apnea monitor citing it for failure to ensure its device conformed to specifications and requirements. That June 30 letter was the result of a series of April 2014 inspections.

A June 27 letter called out Zynex Medical, manufacturer of the NexWave multiple mode electrical stimulator and the IF8000 electrical stimulator for perceived CAPA and design control and verification shortcomings. Zynex, baed in Lone Tree, Colorado, was also hit for failure to have adequate device master records and internal audit procedures.

Out in Napa, California where the weather is lovely and the wine flows, June 25 was probably not a day to celebrate for Dexta Corporation, manufacturer of medical chairs used for Lasik surgery and other procedures. FDA hit them for, among other things, failure to adequately train personnel, inability to verify test results, CAPA issues, and process controls problems.

Henry Ford, a man who tried to build his own utopian city in the jungles of the Amazon and modestly name it Fordlandia, would be proud of the FDA’s devotion to hard work these past few months. Perhaps there is an FDAlandia on some city planners drawing board just waiting for the green light. You never know.

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FDA Lets MDDS Off The Regulatory Hook

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA won’t enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical image communications devices recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health.

The good news came in a guidance released June 20, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.”

Specifically off the hook are MDDS’ subject to 21 CFR 880.6310, medical image storage devices subject to 21 CFR 892.2010, and medical image communications devices subject to 21 CFR 892.2020. Devices in these categories won’t be subject to FDA regulatory enforcement regarding registration and listing, premarket review, postmarket reporting and quality system regulations.

As defined by the FDA, MDDS is a medical device intended to store and/or move edata without controlling or altering the functions or parameters of any connected medical device.

 

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Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

This latest round of warning letters is all about pushback.

The FDA is not happy with the responses it received from Acme Monaco Corp., a New Britain, Connecticut-based manufacturer of medical guardwires for cardiovascular and urologic use.

In an April 28 letter, the agency reminds the company that an earlier FDA inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Parts 820.

Mar Cor Purification in Minnesota was hit with an April 17 letter that found fault with, among other things, its CAPA, complaint handling, and document control. In addition, the FDA said Mar Cor’s March responses were inadequate. Mar Cor manufactures water purificaiton systems used to diagnose diseases.

FDAlogoHeading over to Wisconsin, a March FDA letter hit Cytophill Inc, a manufacturer or synthetic bone graft material, bone void fillers, and an intranasal splint, for a number of shortcomings.

In addition to hitting the firm for below mark CAPA, process and storage controls, FDA warned it about failure to:

  • Control environmental conditions
  • Validate a process whose results cannot be verified by subsequent inspection and test
  • Establish procedures to handle changes to a specification.

As many former FDA inspectors have told us over the years, a bad response to a warning letter is a really bad idea. Most FDA inspectors will work with you if they believe you are acting in good faith to correct the problem. It’s not unlike the IRS. If you call them and work out a lenient, reasonable payment plan, everything’s fine. Unless you miss a payment or two without giving them a heads-up. That’s when the trouble usually begins.

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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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