November 23, 2014

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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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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Unprecedented Energy Demand on Aging Grid: Important Discussions at NYISO Energy Conference

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

New York Independent System Operator (NYISO) had their 2014 Energy Conference in New York City at the end of June. The topics this year included; addressing the aging infrastructure, grid modernization, distributed resources, and fuel diversity. The panelists were a mix of industry experts from utility executives, a university professor, and government experts.

Steve Whitley, President and Chief Executive Officer of the NYISO, talked about the ongoing energy trends taking place in the northeast and the rest of North America. There are historic patterns of electricity demand that are being influenced by extreme weather patterns, the sluggish economy, and the adoption of more efficient energy technologies. Mr. Whitley discussed that within a span of six months, New York State set two seasonal records for peak electrical loads. Those two involved the summer heat wave in June 2013 and the Polar Vortex in January 2014. New York State successfully met these two extreme challenges by maintaining reliability and not resorting to emergency measures.

When it came to the panel discussions, there was plenty of dialogue for the need of fuel diversity. With coal being phased out in most of the northeast and no nuclear expansion planned, natural gas is the primary fuel source for electricity generation. With one of the coldest winters in years, natural gas price spikes and operational challenges demonstrated the need for coordination between the electrical and gas industries. Many of the panelists called for stronger regulatory policies because of the growing dependence on natural gas in North America for electric generation.

electricityTowersOrangeDistributed energy resources were also discussed along with the aging infrastructure. More than 80 percent of New York’s high-voltage transmission lines went into service before 1980. New York State studies estimate that this will require replacements over the next 30 years costing an estimated $25 billion. On the other hand, photovoltaic systems in New York State increased by over 40 percent from 2012 to 2013. Wind generation in the state continues to grow requiring utilities to complete transmission upgrades to move the power from upstate New York to southeastern New York like the Lower Hudson Valley, New York City, and Long Island.

These are all good examples of what many utilities, independent power producers, and government entities are dealing with across North America. As day-to-day energy use and peak demand diverge, this impacts wholesale electric markets, grid operations and planning, as well as, demand-side management programs.

We are all concerned with electric reliability. There are new standards for physical security and cyber security. More stringent requirements are being implemented for system protection maintenance for the bulk electric system. The utilities and independent power producers are assessing and revising their internal controls and programs so that issues are being identified earlier, mitigated and tracked to completion. They are also implementing new risk management programs so that the high and medium risks are receiving the required attention from their executives.

The electric industry has many changes ahead of them in the coming years. There will always be new competition, extreme weather and new technologies, but the companies that are addressing these issues and taking the proper actions will end up being stronger and more resilient. These initiatives benefit all of us, as customers, with a resource that we cannot live without.

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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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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 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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FERC Order to Impose Stricter Physical Security Standards on Electric Utilities

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

On March 7th, FERC released a new order (Docket No. RD14-6-000) directing the North American Electric Reliability Corporation (NERC) to develop new reliability standards for the NERC registered entities, the owners and operators of the Bulk-Power System, to address the risks due to physical security threats and vulnerabilities.

“Because the grid is so critical to all aspects of our society and economy, protecting its reliability and resilience is a core responsibility of everyone who works in the electric industry.” FERC Acting Chairman Cheryl LaFleur said. “Today’s order enhances the grid’s resilience by requiring physical security for the facilities most critical to the reliable operation of the Bulk-Power System. It will complement the ongoing efforts of FERC and facility owners and operators to ensure the physical security of the grid.”

In the Commission’s release the order directed the owners and operators of the Bulk-Power System to take at least three steps to protect physical security.

Gerry Cauley, NERC President and CEO, released a statement on NERC’s website:

FERClogo2“On Friday evening, March 7th, FERC issued a directive to NERC to develop reliability standards to address risks due to physical security threats and vulnerabilities. As you know, FERC Acting Chairman Cheryl LaFleur asked NERC to work with her staff to determine the need for a mandatory standard for physical security. I believe we identified a path forward that focuses on the most critical assets, incorporates risk assessment and further affirms foundational physical security efforts, while providing enough flexibility to avoid prescriptive, lock-step regulation. Any standard must be dynamic and adaptable to the constantly changing threat environment. As we review the order, I take seriously the comments made by all the Commissioners to ensure that a standard achieves the goals identified in a cost effective manner.”

As mentioned in a previous AssurX blog, NERC and Industry Move in the Right Direction for Greater Reliability, security vulnerabilities of the electric grid has been a focus for the regulators and registered entities since the attack by gunmen at a California (Metcalf) substation.

Commissioner John Norris, writing a separate opinion, wants Congress to act on protecting sensitive security information “I believe that our success in developing a comprehensive approach to addressing physical vulnerabilities relies at least in part on Congress taking steps to ensure the confidentiality of sensitive security information regarding the physical vulnerabilities of our grid. Currently, industry remains concerned that confidential security information submitted to the Commission would be subject to disclosure through Freedom of Information Act requests. These concerns have understandably left industry reluctant to provide the Commission with its most sensitive security information related to potential physical threats or vulnerabilities to our power grid. A reliability standard will likely have limited impact if industry, NERC, and the Commission remain unable to safely and securely exchange such information. Thus, I urge Congress to act expeditiously by creating a clearly-defined exemption to the Freedom of Information Act to allow for such exchange of information without fear of disclosure.”

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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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