November 24, 2014

Time to Take a Closer Look at FDA MDDS Moves

Russ King, Managing Partner, Methodsense

Russ King, Managing Partner, Methodsense

The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring.”

The core issue it raises, I believe, is one of data integrity. More on that later.

The new draft guidance cites the growing trend “that many medical devices be interoperable with other types of medical devices and with various types of health information technology.” And further “[s]ince down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public,” the FDA wrote. “Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices.”

The FDA’s interest in this kind of risk based approach has pleased a great many. On the one hand, the draft guidance demonstrates a proactive approach by the FDA for addressing the explosion of mobile health applications in the light of pending legislation on the same topic in the US Congress. It frees application developers to innovate without the additional burden of regulatory compliance, and it dovetails with the rapidly expanding electronic health ecosystem servicing the informational appetites of healthcare providers and patients alike.

Driving this trend are advances in mobile networks and the proliferation of smart phones and tablet devices, which the Cisco Visual Networking index projects will result in 10 billion mobile devices around the world by 2016. This revolutionary expansion constitutes a global service delivery platform for many industries, including health care. Creating affordable and efficient health care systems is a critical challenge for everyone, and mobile health solutions offer tremendous potential by improving and lowering the cost of health care interactions for everyone.

But, there are also some complications to consider with this overall approach. Creating mobile medical device applications is relatively easy and inexpensive, which enables developers inexperienced with the medical device industry to quickly develop applications that are, in fact, medical devices. This ranges from hospital software developers creating interfaces that network device data to Electronic Health Records to college students with a basic understanding of iOS for iPhone applications.

mobile health appRegardless of whether the applications are distributed to clinicians by hospital IT staff or available as a download from iTunes to clinicians and patients alike, once in the hands of the user, the data from MDDS applications will be used for diagnostic purposes –even if the expressed intended use of such applications is to the contrary. We would be naïve at best to believe otherwise.

The use of a device “off label”or contrary to its intended use, however, is not the concern here. Reconciling the conflicts between the intended use of devices and the intentions of end users is a different kind of problem more properly framed by the argument between those advocating stronger more far reaching government controls and those advocating more personal responsibility. Instead, the issue here is one of data integrity and the risks associated with compromising that data.

The draft guidance for MDDS, in essence, proposes a lifting of controls that are otherwise designed to ensure data integrity of MDDS software applications. In the absence of those controls, what assurances will we have that the data stored, transferred or converted was done so in a way that did not create an unintended change in the data? At this point, advocates for the draft guidance might remind us that the FDA “has determined that these devices pose a low risk to the public.”

Here is the rub: however simple the application, there is very little credibility in claiming that a particular software application is “bug free.” Simply ask “how frequently does your iTunes Store app alert you to application updates for bug fixes?” This gives you a sense for the state of software development in the absence of strong quality controls and the rigorous software lifecycle planning that are part of medical device regulations and standards, such as 21 CFR Part 11 and IEC 62304.

If MDDS application developers are not required to have a competent software development lifecycle, not required to test or validate their software, not required to manage their quality…what assurances does the user have that the software operates as intended, and the data is not compromised in some fashion due to software bugs? And, if we take for granted that the data from MDDS applications will be used for diagnostic purposes despite their stated intended use, what risks are we accepting on behalf of patients?

In short, the risk of misdiagnosis, either by the clinician or the patient themselves, increases as do the consequences for misdiagnosis. The more widely distributed mobile health care monitoring and treatment options become and the fewer requirements for ensuring data integrity, the more likely patients will be exposed to such risks.

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 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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Charles Darwin, Social Media & The FDA’s New Guidance

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

If someone out in there in the wild wonderful world of the Web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth his or her salt will tell you it’s often best to let the attacker eat silence rather than draw more attention to their criticism or cheap shot.

But if the criticism is relentless, or damaging and unfair, if it looks to be gaining traction, then a measured response can be part of the solution.

The FDA just released a guidance it says “responds to (among other things) stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party.” In other words, how to fight back fairly.

But the short guidance is vague on specifics, though it does give us a “helpful” reminder that the Internet makes it much easier for third-parties to easily disseminate information about your products and your company. The agency calls it User-Generated Content (UCG). I don’t mean to sound like an elitist snob, but this sounds kind of obvious to me.

“I wouldn’t call this guidance useless…well, yes I would,” a device industry consultant told us. He asked to remain anonymous on the off chance anyone at the FDA ever reads this blog.

Is the guidance helpful? You be the judge. Here’s how the FDA advises a drug or device company to address negative and or inaccurate claims online:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

I suppose writing all of this down somewhere doesn’t hurt anything except the trees killed when it is printed out. Still, it feels a bit like FDA is talking down to future winners of the Darwin Awards. That’s the “prize” named in honor of Charles Darwin, the father of evolution. The Darwin Awards commemorate those who “improve our gene pool by removing themselves from it.”

Here’s a good example of a Darwin Award: In 2000, a motorcycle taxi driver challenged his neighbor to stand beneath a hornets’ nest, while two men pelted it with stones. The 53-year old man should have known better, but he had a local reputation as a strong man to uphold. He stood beneath the nest and the pelting commenced. The man endured the pain of countless stinging hornets before expiring from the toxic injections.

To be fair, if you need an FDA guidance to tell you to “be accurate,” I’d also say you may need a reminder to stay away from hornets or men holding stones. Otherwise, there’s no harm bookmarking this new guidance in your computer.

But don’t print it out, please. It’s not fair to the trees.

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FDA Acts to Harmonize Global Adverse Event Reporting

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a small world after all. One of the by-products of globalization is the speed and spread of everything from t-shirts to medical devices.

But everything has its plusses and minuses. When it comes to globalization, a plus for American’s is something like high-quality inexpensive clothes from my haberdasher of choice, J. Crew. On the minus side, we’ve got MERS hitting our shores.

Of course, t-shirts are one thing and safe medical devices and drugs are quite another.

As the FDA has learned, health regulations and standards in one nation do not often translate, figuratively and literally, to another nation.

Zeroing in on one of the most pressing requirements, FDA is working with the International Conference on Harmonization (ICH) to harmonize global adverse event reporting forms and requirements. It won’t be easy, but the two organizations appear to be off to a good start.

A recent notice in the Federal Register outlines a step forward covering three parts of the globe: the United States, Japan and the European Union. It does not address other parts of the world.

The core of the new effort is the Periodic Benefit-Risk Evaluation Report (PBRER) draft guidance first issued in 2012, building on a guidance issued in 1997 and amended in 2004. PBRER is designed to “promote a consistent approach to periodic postmarket safety reporting among the ICH regions and improve efficiency by reducing the number of reports generated for submission to regulatory bodies.

FDAlogoFDA advises that companies operating in more than one country or region may find it easier to prepare a single PBRER rather than preparing multiple types of reports for multiple regulators.

FDA also outlines some situations where medical device companies must be granted a waiver, and other situations where they can apply for a waiver. Existing regulations permit applicants to request waivers of any post marketing safety reporting requirement, and the information collections associated with those waiver requests are “generally are approved” under existing regulations, FDA says.

Comments are due by June 9th.

 

 

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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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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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