October 31, 2014

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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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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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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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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