August 30, 2015

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

Tamar June

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

Looks like it’s crunch time for medical device manufacturers. Whether they submit one or 10,000 medical device reports (MDRs) to the FDA per month, they are required to go all electronic come August 14, 2015. No faxes, no mailed in reports, no more burned CDs. Device manufacturers have two choices. Either use the eSubmitter, or utilize the HL7 ICSR. Both go through FDA’s Electronic Submissions Gateway.

If device manufacturers haven’t yet setup their ESG accounts, they better get started right away. It takes at least two weeks to get on board with FDA, as well as additional time to test the submissions. FDA issued another reminder and an updated implementation package this morning:

fancyFDAlogoOn August 14, 2015, the eMDR final rule goes into effect, requiring manufacturers to submit medical device reports (MDRs) to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, and importers. There are two options available to all reporters for submitting eMDRs: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).

Today, the FDA released an updated implementation package with the system requirements to enable manufacturers that chose the HL7 ICSR submission option to prepare for and test eMDR submissions.

As a reminder, both eSubmitter and HL7 reporting options transmit MDRs to the FDA using the FDA Electronic Submission Gateway (ESG), a secure entry point for all electronic submissions to the Agency.

Manufacturers should consider registering for an ESG account and submit a test submission as soon as possible to ensure that they are electronic submission compliant by August 14, 2015, regardless of which transmission method they choose. Manufacturers may begin testing their submissions as early as June 29, 2015.

Information on the FDA ESG and steps to obtain a production account, please visit the Electronic Submissions Gateway page.

For more information about how to prepare for eMDR, please visit the FDA eMDR page.

After this deadline, there will be no more extensions. Even if device manufacturers rarely submit reports, they need to make sure they are ready just in case.

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FDA’s Shuren Works to Assure Device Industry Innovators

Michael Causey, Editor-in-Chief, Association of Clinical Research Professionals

Michael Causey, Editor-in-Chief,
Association of Clinical Research Professionals

Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.

If potential users believe a product’s benefits outweigh its potential risks, Shuren said the agency is more likely to approve it today. “We want to make the U.S. a much more attractive market for medical device innovations,” he told attendees at this month’s Drug Information Association (DIA) convention in Washington, D.C., acknowledging that America has some of the toughest standards blocking the way between device manufacture and approval.

Jeffrey E. Shuren, M.D., J.D., Director, CDRH

Jeffrey E. Shuren, M.D., J.D., Director, CDRH

Shuren pinned a lot of his hopes on the Medical Device Innovation Consortium (MDIC), the first public-private partnership devoted to the advancement of regulatory science in the medical device industry. MDIC aims to coordinate the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology. It will hold its annual meeting September 25 in D.C.

Boasting 49 members, including large and small device companies, PhRMA, venture capitalists, consumer groups, FDA and NIH, MDIC has been active over the past year or so, holding a slew of meetings across the U.S. (and Japan), spreading the good word of innovation.

Shuren also talked about the FDA’s May guidance which offers additional detail regarding how it will consider patient needs as it weighs risk/benefit calculations. “We’re looking to find ways to reduce medical device time to market,” he said. CDRH is making “changes in our approach” as evidenced by the guidance and the FDA’s work with MDIC, among other things, Shuren stressed.

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FDA Moves UDI Initiative Further Down the Production Line

Michael Causey, Editor-in-Chief, Association of Clinical Research Professionals

Michael Causey, Editor-in-Chief,
Association of Clinical Research Professionals

We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. But it’s only fair to give equal space to something when they seem to get it right. Take the Agency’s Unique Device Identification System (UDI).

Readers of this blog might have different experiences with it – and we’d like to hear about them, good or bad – but you’ve got to tip your hat to FDA because they’re trying to get it right.

Last month, FDA launched the Global Unique Device Identification Database (GUDID), a searchable website containing a listing of all UDIs. Expectations, both from industry and the agency, are high for this system implemented to simplify the identification of many regulated medical devices used by patients in the United States.

GUDIDThe complex infrastructure, which will be phased in over several years marked by a variety of deadlines that began in 2014 and are slated to wrap up in 2020, offers a number of potential benefits, including:

  • Speeding and improving the accuracy of the reporting, reviewing and analyzing of an adverse event.
  • A quicker means to identify a device and extract important information about it.
  • Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.

Ultimately FDA hopes its UDI can become a worldwide model, too.

It’s worth noting that FDA’s former point man for the initiative, Jay Crowley, continues to lead the bandwagon now that he’s ensconced in private practice with USDM Life Sciences. He’s led a number of webinars and given a number of talks that make a persuasive case for the positive impact UDI will have on the device industry. Sometimes, a former FDAer spends the next ten years of his or her career criticizing the very program they led. Not the case with Crowley and that bodes well for UDI.

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Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Just when we’d all decided Washington lawmakers couldn’t do much more than enjoy their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.

It’s called the 21st Century Cures Act and its got a lot of device and drug makers excited. It’s been under development since April 2014. Amazingly, the version Congress released recently is almost 50% shorter than the earlier draft. In a city full of bureaucrats who write memos about memos, that’s a pretty incredible feat.

Fresh off a May 15 Congressional vote moving the law closer to passage, Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), praised Subcommittee Chairman Joe Pitts and Ranking Member Gene Green for their bipartisan work “recognizing the importance of medical technology innovation in answering the pressing challenges facing America’s health care ecosystem.”

Joining AdvaMed, among others, Leahy applauded legislation he says “provides substantive proposals to improve the regulatory process, while addressing ongoing challenges in obtaining adequate reimbursement for the cures and treatments that patients need.”

Among a myriad of potential changes, the Act would clarify the standardization of eligibility information in clinicaltrials.gov, and spur the Department of Health and Human Services to forge ahead with additional public/private partnerships with grants to promote patient advocacy groups and research of disease causes, especially for rare diseases.

SixGroupsAccording to the folks at Hyman, Phelps and McNamara, the new version is broader in terms of Qualification of Drug Development Tools. For example, “it now addresses biomarkers, surrogate endpoints, and other drug development tools; the first discussion draft focused primarily on surrogate endpoints,” reports the firm’s Law Blog. “On the other hand, it is narrower because it does not affect devices. The section also removes many of the formal procedures and timelines from the first discussion draft and provides FDA with more discretion in the development of the program.”

There’s still a lot to dissect from the Act, and, while passage appears likely, some provisions could still be tweaked or cut entirely. But one this is clear: Congress is probably going to shock a lot of us by actually pulling together a relatively bi-partisan piece of legislation and placing it on President Obama’s desk before the end of the year.

Who’d have thought, right? Now, maybe these distinguished men and women can take a hard look at our nation’s infrastructure, tax code, and maybe a few dozen other issues that would also benefit from some good, old-fashioned bipartisan discourse.

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Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

Russ King, Managing Partner, Methodsense

Russ King, Managing Partner, Methodsense

IEC 62304, the international standard that defines software development lifecycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop software components. Conformance with this standard demonstrates that there is a software development process in place that fulfills the requirements of the Medical Device Directive.

If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. This standard requires all aspects of the Software Development Life Cycle (SDLC) to be appropriately managed to ensure patient safety, including:

  • Development and code reviews
  • Risk management
  • Configuration management
  • Incident and bug resolution
  • Validation
  • Maintenance

dnachainThe most common mistake medical device manufacturers make is failing to assess which elements of risk their software mitigates. These are the elements that must be addressed by IEC 62304. For example, what would happen if the creator of a hoist didn’t properly vet the software that signaled the hoist to lower the patient at a certain speed? If a patient were lowered too quickly – or not at all – there would be a risk management nightmare. Since software plays a role in the Basic Safety functions of the hoist, it must comply with 62304’s requirements.

Common software functionality manufacturers fail to recognize as IEC 62304 compliance issues include:

  • Alarms and Alerts often an Essential Performance requirement because they are intended to detect abnormalities
  • Speed & Position Sensors use of software to limit range of motion, speed and force, which are Basic Safety concerns
  • Algorithms remove the software and the device is no longer able to operate as intended, resulting in the algorithms being part of Essential Performance 

It is critical to have clearly defined processes for your company and your Software Development Life Cycle, in particular. IEC 62304 identifies several expectations related to the information that should be included in your SDLC procedures, including:

  • Documentation of your process – document management is essential for meeting compliance goals
  • Software of Unknown Pedigree (SOUP) – manage your SOUP appropriately
  • Document Development – make certain you are sufficiently resourced to support document development needs
  • Version Control & Updates – clearly define software updates and how software will be maintained in a validated state.

Medical device manufacturers frequently seek 3rd party software development assistance. However, the manufacturer remains responsible for the device software. Important areas to consider when contracting out your software development include:

  • Supplier Management Processconfirm that your software vendor complies with IEC 62304 and their processes are reviewed during vendor audit
  • Quality Agreement – confirm that:
    • It defines vendor responsibilities and IEC 62304 Deliverables
    • Vendor procedures used for software development will be provided to you and the test lab for review
  • Establish your SDLC – at minimum, your process will define acceptance criteria (i.e. IEC 62304 compliance and deliverables) from your vendor

Once you know you must comply with IEC 62304, how do you go about preparing? To start, know that compliance with this standard is defined as implementing all of the processes, activities and tasks identified in the standard in accordance with the software safety class. 62304 itself does not prescribe a particular organizational structure or specific format for documentation. Compliance is determined by a review of all required documentation, including the risk management file.

IEC 62304 file will be reviewed to ensure:

  • It contains all required documentation including a risk management file
  • Procedures meet the requirements of the standard
  • Each check list item is satisfied
  • A product review is conducted and further a review of the relevant software segments if it has been decided that the software performs Basic Safety or Essential Performance for your device

If you get caught in any of the above-mentioned pitfalls, you’ve probably got a problem. You will either not receive a report at all, or will receive a report that says you failed somewhere in IEC 60601-1 or IEC 62304.

Because the standards are voluntary in the US, you don’t necessarily have to make product changes. However, for each “fail,” you will be required to provide justification for each deviation. If you have valid justification, your device should still attain regulatory approval from the FDA, although developing this justification can be a lengthy process in itself. In the end, though, you may find it more efficient to comply with IEC 62304.

Download your IEC 62304 action list here. 

Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market. He can be reached at (919) 313-3962 or rking@methodsense.com.

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FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR

No more paper. That’s what the FDA requires from the medical device community starting August 14, 2015 with regards to electronic medical device reporting (eMDR). With the draft guidance initially introduced in 2009, and the final rule released in 2014, medical device manufacturers have a little over three months to comply. In the infographic shown below, CDRH submissions overall have dramatically increased through the years. Back in 2006, only 1,575 records were submitted electronically by CDRH to FDA. At year end 2014, electronic submissions to CDRH had reached a record high of 812,443 and are expected to continue to rise going forward.

 

FDAeMDR

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FDA Works to Clarify Device Data Collection Priorities

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of approval for premarket approval applications (PMAs).

The agency says there are some instances where it may consider it acceptable to collect certain data in a postmarket setting rather than premarket.

FDAlogoOne area is mature technologies. For example, a subcutaneous implantable cardioverter defibrillator (S-ICD) has the same basic elements of an ICD, which have been used for decades. Clinical and preclinical evaluations in the premarket setting for the subcutaneous ICD were tailored to collect data on the new aspects and to evaluate functionality of the device, while more detailed safety data is collected in a postmarket study.

Other situations include an urgent public health need, especially in a situation where postmarket testing would do a better job confirming the benefits of a device.

The guidance spells out several other examples where it may be appropriate, including:

  • Migration, an approach used when approval of Class III in vitro diagnostic devices previously approved, licensed, or cleared assay is shifted to another system for which FDA hasn’t evaluated assay performance, is suitable in cases when sufficient knowledge can be gleaned for the documentation of design controls, risk analyses, and prior performance studies on an already marketed system.
  • Confirmation of mitigation effectiveness for a known risk in a post-approval study.
  • Modifying warnings, contraindications, and/or precautions in approved labeling.
  • Approval for an intended population beyond what was fully evaluated in the pivotal trial, with a confirmatory post-approval study.
  • Assessment of long-term performance in a post-approval study.
  • Assessment of rare adverse events in a post-approval study.
  • Confirmation of bench data with clinical data collected in a post-approval study.
  • Where the performance of a particular device type is well-studied, documented, and understood
  • Where long-term outside the U.S. clinical performance data is available but deemed insufficient.
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FDA Plays Catch Up In Brave New World of Electronic Consent

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool which promises faster, cheaper access to potential trial participants, and unimagined data streams to boot, the guidance comes at an important time for the clinical trial world.

Never accused of being early adopters of technology, clinical trial folks need to heed the FDA’s new guidance. Used properly, it can serve as something of a roadmap as everyone veers into previously unchartered territory.

First, understand the FDA’s expectations as laid out in the new guidance. It expects subjects to receive enough information to allow for an informed decision and an easy way to ask questions and receive jargon-free answers.

When using an eIC, FDA requires it to contain all elements of traditional IC, but also that any interactive eIC program be easy to navigate, including the means for the subject to stop and return to it later. Further, eIC tools must meet any subject’s physical limitations, e.g. poor vision or impaired motor skills. Perhaps most importantly, the eIC “must be presented in a manner that minimizes the possibility of coercion or undue influence regarding the subject’s decision to participate in a study.

FDAlogoFDA requires an investigator to obtain the informed consent. However, if the investigator delegates the responsibility, it is their obligation to hire a surrogate with demonstrable credentials. Nothing new there. But it gets a little more complicated when it comes to eIC. For example, consent can be handled remotely. However, when the consent process is not personally witnessed by study personnel, the eIC should include a method to ensure that the person giving consent is the person participating, or the subject’s legally authorized representative. The subject must also have the opportunity to ask questions and receive answers before actually signing electronically.

A subjects’ questions can be answered in a number of ways, including text message, phone calls, and videoconferencing. The data and communications must be secure. Subjects should also be told in advance how and when they will receive answers to questions and given information on how to contact an appropriate individual with questions about the investigation, the subjects’ rights and whom to contact in the event that a research-related injury occurs.

FDA also issues some eIC direction to IRBs. “A critical part” of an IRBs responsibility is to ensure that there is an adequate informed consent process in place that protects the rights and welfare of subjects participating in clinical investigations. Further, the agency recommends, but does not outright require, that an investigator discuss plans for using eIC with the IRB before finalizing development of the eIC to ensure that the IRB agrees that a particular format may be used for obtaining informed consent.

The FDA remains neutral when it comes to archiving documents. That said, the agency does weigh in on “cloud” and other remote storage solutions. Data privacy laws and regulations that apply to the remote site, in addition to those that apply to the research site itself, “may apply and should be considered.”

Finally, the agency reminds us that when one of its cheerful investigators is waiting in your lobby, he or she will be expecting access to records and reports made by the investigator including site-specific versions of eICs, materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs. Any updates to the documentation must also be available for review.

Comments on the guidance are due May 8. When submitting your input, refer to docket no. FDA-2015-D-0390

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Brookings Looks to Advance Medical Device Postmarket Surveillance System

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmarket Surveillance System (MDS), says a new report by the Brookings Institution with input from a wide swath of public-private players including the Office of Surveillance and Biometrics Center for Devices and Radiological Health.

The Brookings paper, “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” calls for an MDS that’s responsible for coordinating medical device postmarket evidence activities, then builds and facilitates access to a network of data partners. The report also stresses, however, that the MDS should not work in a vacuum. Instead, it should be built upon and coordinate with existing public and private sector programs to better leverage existing expertise and resources.

Brookings envisions a system that collaborates with other groups to support other high-priority evidence needs that may benefit from the same infrastructure, including product tracking and utilization, clinical quality improvement, and economic analysis of medical device-related care.

medicaldeviceThe Brookings Planning Board (PB) suggests the new MDS be implemented and managed by a wide array of stakeholders. But none of this is going to happen overnight. The PB envisions a seven-year rollout, with the first two years devoted to an incubator project tasked with developing a five-year MDS implementation plan.

Ideally, the incubator project would be initiated by the FDA. The report lays it out pretty clearly. “Without some initial seed funding and active FDA engagement, it will be difficult to assure the purpose and sustain the momentum necessary for other stakeholders to fully engage in the development of MDS.”

Finding funds won’t be easy, the report authors acknowledge. For example, the FDA does not currently have any specific appropriations dedicated to paying for the initiative. Congress enacted legislation in 2012 mandating the agency expand the Sentinel system to include medical devices. Unfortunately, folks on Capitol Hill didn’t come up with or identify other sources for the cash to fund it. The PB calls for “more explicit Congressional support” to support and fund the infrastructure required to emerge with a robust system of medical device surveillance in this country.

While Washington’s culture of gridlock isn’t exactly encouraging, maybe the prospect of safer medical devices developed in a climate that encourages innovation is the kind of thing a few of them can actually support on the same day. We’ll see.

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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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