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Are We Too Hard on the FDA?

May 18, 2012 By Leave a Comment

One title in particular jumped out at me when I researching for my blog this week: Advice from a VC to startups: Speak no evil about the FDA.  What?!?  OK, so perhaps I have been trashing the FDA a bit lately, but not without cause… Right?  Here’s a bit of an excerpt from the article:

After a short complaint about the FDA coming from another panelist — John Ryan of Onset Ventures — Juliet Bakker, founder and managing director of Longitude Capital, said that her advice to portfolio companies is to be always be respectful of the FDA.

“After all, they are here to protect us,” she said.

Bakker added that on many occasions companies and regulatory consultants don’t ” bother to answer the questions that the FDA has asked” or give the answers that they want to give. That, she said, creates delays. And delays are anathema to the venture capital and startup community eager to see a return on investment.

Are we too hard on the FDA? Should we be more sympathetic to their cause?  What do you think?

 

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What Does That Mean?

May 4, 2012 By Leave a Comment

FDA, PMA, SAE, V&V, CPT…  I see acronyms tossed around all the time when researching for my blog and have no clue what most of them mean.  I have never dared mention my lack of understanding to anyone for fear that I might come across as dim-witted, but last week I saw an article in MedCityNews that made me feel like maybe I was not alone. The author lists the above acronyms as the Top 5 Anxiety Provoking Med-Tech Acronyms (APMAs).  In case you are as clueless as I was, here’s the rundown:

Food and Drug Administration

Pre-Market Approval

Serious Adverse Event

Verification and Validation

Common Procedural Technology

Is there an acronym that really makes you PO’d?

Add your (least) favorite med-tech acronyms to the APMA Hall of Shame by clicking here.

I think I am going to form my own support group called PWDUAAAAI.  (People Who Don’t Understand Acronyms and Are Afraid to Admit It)

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Grow Up, FDA

May 3, 2012 By Leave a Comment

The medical device review process adopted by FDA has won many critics for years for being too complicated, vague and slow, especially when compared to the European device approval process. In an internal report, the U.S. Food and Drug Administration is defending its approval process for medical devices, while trashing some of the regulatory practices used by its European counterparts.  FDA officials are critical of a number of EU standards, noting that European regulators seek less evidence and allow “private, for profit companies” to sign off on product approvals in member countries.  Even if the EU system is quicker, it is far from better, the report argues. U.S. companies have repeatedly argued that they lose valuable time and money waiting for FDA approval as they seek to improve the lives of patients they serve.

I am reminded of when my two sons get in a fight.  I am usually alerted to the battle when someone screams, “He hit me!!” to which the other one replies, “Well, he kicked me first!” as if that negates any responsibility he had in the altercation. Whether or not the EU has an effective process really has nothing to do with the FDA’s efficiency.  I believe the FDA needs to take care of their own problems and not worry about what the Europeans are doing, or, as I tell my sons, “take responsibility for your own actions and keep your hands and feet to yourself.”

 

 

 

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Patients’ FDA Act

April 26, 2012 By Leave a Comment

Sens. Richard Burr (R., N.C.) and Tom Coburn (R., Okla.) recently rolled out a new bill designed to significantly improve the regulation of drugs and medical devices at the FDA. The bill, called the “PATIENTS’ FDA Act” is “a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.”

The basic premise behind this piece of legislation — as expressed by Senators Burr and Coburn — is that the FDA needs to be subject to a great deal more Congressional oversight if it is to fulfill its public health mission in a predictable and timely manner and to keep medical innovation and job creation (related to the development of new drugs, diagnostics, and medical devices) from going overseas.

I found Forbes take on the bill interesting.

Avik Roy states “A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.

The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, “Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, it is their duty is to stop it—and stop it they will.””

The entire legislation is 55 pages in length, although the summary is a mere 7 pages.  Something to keep on your bedside table to lull you to sleep at night…

 

 

 

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The FDA Actually Wants to Help You

April 19, 2012 By Leave a Comment

In announcing the next phase or version 2.0 to the Innovation Pathway program introduced in February last year, CDRH Director Jeffrey Shuren said that the program is going to bring about a new way of doing business at the FDA. The new regime will be one where safety and innovation are complementary rather than at odds with each other. Through Innovation Pathway 2.0, the goal is to get entrepreneurs in companies or academia who are designing the next innovative, breakthrough product to collaborate with the FDA early on. That will help iron out regulatory uncertainty that tends to gobble up time when a novel product is actually submitted for a de novo or a premarket approval.

I like the sound of this, but I’m not going to hold my breath…  We’ll see what happens.

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Medical Device Industry vs. FDA

April 11, 2012 By Leave a Comment

The debate continues… Is the FDA doing the best it can, or is it slowing the medical device approval process?   It depends on who you ask.  A new bi-partisan report from GAO praises the FDA for trying to fix the process, then basically notes they haven’t actually fixed it.

The medical device industry says FDA is too cumbersome and slow and that it is thwarting innovation. FDA says it is doing better than it gets credit for and slams some device industry studies backing its position as flawed and misleading.

“Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years,” GAO notes. “Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days.”

Obviously the medical device industry has something to gain if the FDA speeds up its approval process.  So, the question remains “Is the FDA doing its best?” I blogged last week about a recent Consumer Reports Poll in which 8 in 10 people surveyed allocated more importance to avoiding safety problems in devices, as opposed to encouraging innovation or to getting them to market faster.  So, if you subscribe to the old mantra “the customer is always correct”, perhaps the FDA is doing exactly what it was intended to do.

 

 

 

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Perhaps I’m Wrong About the FDA

April 2, 2012 By Leave a Comment

I have blogged in the past about the fact that perhaps the FDA is taking too long to approve much needed life saving medical apparatuses, especially devices that are simply advancements of devices that are already in use.  Well, it seems that most consumers don’t agree with me.  In fact, according to a recent Consumer Reports Poll, more than 8 in 10 people surveyed allocated more importance to avoiding safety problems in devices, as opposed to encouraging innovation or to getting them to market faster.

Other highlights from the report include:

  • 91 percent said each implant should be safety tested before being sold even when similar implants were in use.
  • 71 percent said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
  • 94 percent indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device.
  • 95 percent said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
  • 66 percent indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

Frankly, I’m torn.  I still believe that a lengthy and tedious FDA approval process can lead to lives being lost as people await life saving devices, some of which are actually already in use in other countries.  I also understand the consumer’s concern for the highest safety standards possible on any kind of mechanism that could make the difference between life and death for its recipient.

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Is It a Medical Device, Or Not?

March 2, 2012 By Leave a Comment

Is it a medical device, or not?

Although the definition of a medical device hasn’t changed, the issue is the intended use of certain mobile health products that previously weren’t classified as medical devices. Now, because of the way certain products are being packaged and marketed, they could potentially fall into the category of a medical device, and thus would need to conform to FDA requirements. Part of the problem is that some manufacturers of medical apps may not even know that they are making a regulated device, according to comments that AdvaMed submitted to FDA in October. The association recommended that FDA reword its document into “plain language” as a result. “If you have an application that works on an iPad and the app says that it specifically helps diagnose a certain disease, then the app becomes a medical device,” says Streed. “The iPad is not considered a medical device, but the software would be. However, if an iPad was called a medical iPad, [for example], and the application could only be used on the medical iPad and is marketed as a medical iPad for use and diagnosis [of a disease], then it would be considered a medical device.”

I don’t know if I’m more confused or less confused…

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FDA, What Exactly Are Your Plans?

February 20, 2012 By Leave a Comment

I have been reading about the FDA launching its Strategic Priorities for the CDRH for 2012. Here are the highpoints of the Priorities:

  1. Fully Implement a Total Product Life Cycle Approach
  2. Enhance Communication and Transparency
  3. Strengthen Its Workforce and Workplace
  4. Proactively Facilitate Innovation to Address Unmet Public Health Needs

At first glance they all seem to make sense.  As someone who is new to the workings of the FDA, my plan was to read the document over and not make any judgments, as I really lack the wisdom or knowhow on the subject to assume to criticize.  However, as I read through the document, it seemed to me that most of the goals under each Strategic priority are fairly ambiguous.  There was a lot of “improve” this, “develop” that, “implement a plan”, or “take steps towards”, which doesn’t clarify in any detail what is actually to be done.

I used to do a lot of work with the Dale Carnegie program.  One of Mr. Carnegie’s rules for goal setting was that the goal had to be specific, measureable, and attainable.  Although precise dates are mentioned for each goal in the CDRH’s plan, it seemed to me that there isn’t enough detail in the goals themselves to be able to measure if anything has actually been accomplished.

Again, this is just my first impression of something that I know little about, so take it for what you will. I applaud the FDA for its effort and hope that perhaps internally they do have the specifics in place.  In the meantime I will implement a plan for improving my attitude and take steps towards learning more about the FDA so that I will develop a better understanding of this organization- how’s that for a specific goal?

 

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Is the FDA Costing Lives?

October 17, 2011 By Leave a Comment

In the U.S. entrepreneurs are forced to test promising medical devices in costly animal studies for long periods of time before they can advance their products into clinical trials, placing them years behind their European counterparts. When clinical studies finally do get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.

In response, American device makers are moving their business overseas. Between 2004 and 2010, more than half of all innovative devices were first approved in Europe. Because more devices now launch in Europe, companies increasingly study the products there. In 2004, 86.9% of all medical-device studies listed in www.clinicaltrials.gov were being carried out in the U.S. By 2009, only 45% of clinical trials were run here.

There are countless examples where devices already marketed in Europe were still required to undergo costly, multiyear animal trials in the U.S. The FDA could allow human data generated in Europe to obviate the need for animal studies in American pigs and sheep. Surely the scientific data generated by following European patients is more informative than what can be learned by placing a new device in an animal.

If the FDA is serious about promoting medical innovation and advancing the public health, perhaps they should take a cue from their colleagues in Europe.  A 2011 study by the Boston Consulting Group of European device approvals suggests that Europe’s more expedited process is just as rigorous and safe as the FDA’s.

How many lives are lost while waiting out the years of studies required for life-saving devices to qualify for clinical trials here in the US?  Sadly, the same devices are already saving lives in Europe.

 

 

 

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Do You Understand the FDA’s Mobile Medical “Guidance”?

July 25, 2011 By Leave a Comment

Dane Stout of Anson Group wrote an analysis of the FDA’s mobile medical draft guidance in which he highlights significant statements he gleaned from the FDA’s document and provides subsequent analysis commentary.

Jon asked me to do a blog on Dane’s analysis and, I have to admit, given the scope of the FDA’s draft, the prospect was a bit daunting.  Consider the fact that I am a stay-at-home mom who usually does her blogging with Spongebob blaring in the background along with the occasional outbreak of screaming, fighting, or hysterical crying.  While it’s all fine and good for me to do a bit of research and make a few witty comments about this cool technology or that cool technology in between sending children to their rooms or mediating little boy arguments, this particular endeavor seemed to be completely over my head.  Nonethless, I decided to give it a go.

I found it helpful to me that Dane explained some of the definitions of the terms that the FDA used in the draft.  For instance, how does the FDA actually define a mobile medical app?

A. Mobile Platform “defined as commercial off-the-shelf COTS computing platforms, with or without wireless connectivity, that are handheld in nature”

Anson Analysis: I’m not sure why this included, since I don’t know personally of even one mobile platform (handheld) that is not connected to a network. If there is, then no one is buying it. In fact, I have a vintage 2004 Palm device in my garage at home I’ll let you have for nothing (why I’ve kept it is something else that needs to be analyzed). This indicates to me that FDA still views a network as something “external” to medical devices, rather than the centripetal force it presses upon the dismantling and restructuring of the healthcare delivery system, drawing human interactions, processes, devices and information towards complete dependence upon interconnected networks.

 

B. Mobile Application (Mobile App)

“For purposes of this guidance, a mobile application or “mobile app” is defined as a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.”

Anson Analysis: The FDA gets this one right in my opinion. I was concerned that the rapid development of downloadable smartphone apps, first introduced on the iPhone platform, would ignore the development of HTML 5, which many people, myself included, feel will bring the web model back into prominence as an equal, if not preferred, delivery model. If you’re unfamiliar but interested in learning more about HTML 5, you can read an overview about it from O’Reilly
C. Mobile Medical Application (Mobile Medical App)

“is used as an accessory to a regulated medical device; or
transforms a mobile platform into a regulated medical device”

“The intended use of a mobile app determines whether it meets the definition of a “device”

Anson Analysis: FDA is staying fairly close to the script here when it comes to defining a mobile medical app. It maintains regulatory jurisdiction for mobile apps that connect in some manner to an existing medical device (aka the accessory rule), and it covers apps that through their intended use and function “transform” a mobile platform (here again the term platform as FDA uses it means a particular handheld device, not “platform” in the sense that technologists tend to think of. So as more functionality converges into these mobile handheld “platforms”, ala GPS, location based services, accelerometers, etc. mobile apps that leverage new hardware or software features inherent in the COTS device can “transform” it into a regulated article. Finally, as we frequently remind our clients, at the end of the day it all comes back to intended use. In the mHealth Regulatory Coalition work we identify the confusion that intended use creates for the new blurry world of wellness and medical treatment, but for now FDA is sticking with the current interpretation without too much change.

 

D. Regulated Medical Device

Anson Analysis: Reiteration of using the definition of a device in section 201(h) of the FD&C Act and the reliance on the existing classification system. Again in the work that we’re doing as part of the MRC, we intend to introduce entirely new classifications for mHealth products that take into account their uniqueness that FDA actually acknowledged on page six.

He also explains what the FDA doesn’t consider to be a medical app:

Mobile apps that are not considered mobile medical apps:

• “electronic “copies” of medical textbooks

• Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health or wellness

• Automate general office operations like billing, inventory, appointments, or insurance transactions

• Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication

• Mobile apps that perform the functionality of an electronic health record system or personal health record system

Anson Analysis:

• There are of course on-line medical textbooks and e-reader functionality to enable electronic copies of textbooks to be accessed on mobile devices. However, as is frequently the case, innovation rarely stops at simply recreating a physical format into an electronic format without some additional capabilities and enhancements beyond printed paper. Embedding clinical decision support rules as algorithms that access patient data and then point a physician to a particular section of a physician reference manual or peer reviewed journal article is not simply an “electronic copy” function. App developers need to be careful in this space.
• Health and Wellness boundaries with medical use, as previously discussed, is still a gray, fuzzy area that still requires tighter and clearer boundary definition, but this is a step in the right direction.
• Automating office functions used to be pretty clear, and still can be, but patient medication reminders and other automated functionality like intelligent pill bottles communicating to a mobile app are not simple diary input automation or calendar reminders.
• FDA allows for the use of generic functions, such as the example they use in the guidance draft of magnification properties, but also point out in the foot note on page 11 that commercially marketed medical functions for medical purpose magnifiers are classified devices under 21 CFR 886.5840 Magnifying Spectacles. Again, what is being marketed will determine whether or not the function is generic or constitutes a regulated claim.

I also appreciated the way Dane “translates” (What the FDA might be saying):

“FDA recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and potential benefits and risks to public health”

Anson Analysis: (What FDA might be saying)  ”We can’t possibly keep up with everything going on, it’s overwhelming, so here is how we’re going to discharge our duties to the best of our ability at this point in time in this area.”

“narrowly-tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device. FDA believes that this subset of mobile apps poses the same or similar potential risk to the public health if they fail to function as intended. Using mobile or other innovative platforms along with a mobile medical app to perform medical device functions does not necessarily change the intended use or the risk to patients if the device fails to operate properly”
Anson Analysis: (What the FDA might be saying)  ”We’ve selected those apps that clearly fall into the medical device definition in our view, and we don’t see any reason or way to excuse the manufacturer of these apps from the same regulations as traditional medical devices.”

 

While admittedly, I still don’t completely understand the process, I certainly have a better grasp of what is involved with FDA procedures.

Now if someone could just explain to me why my four-year old insists on sitting next to me and incessantly beating the bottom of a coffee can with a wooden stick while I am trying to work, my world would be complete…

 

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If FDA Knocks, Are You Ready to Answer?

July 17, 2011 By Leave a Comment

If I look back over the past couple years of business, I notice a common theme from client engagements: address FDA-related non-compliance issues. Sure, maybe this is to be expected since our business focuses on the medical device industry. Regulatory compliance is the name of the game and in our wheelhouse of services and expertise.

But I continue to be a little surprised by some of these engagements and how little the client companies are prepared in case the FDA comes for a visit.

If you are a medical device company (or other company regulated by FDA), you should ALWAYS be prepared for visit from FDA. Technically, FDA is supposed to conduct site inspections of registered companies every couple of years. And if you happen to have product issues, expect the nature of the inspection to be quite a bit more stringent.

What can you do to prepare for a FDA inspection?

  • Conduct internal audits of your processes per Quality System Regulations (which you should be doing any way).
  • Bring in an objective third party at least once a year to thoroughly audit your processes and procedures against FDA regulations.
  • Conduct management reviews annually (and I suggest semi-annually). Be critical of complaint handling, CAPA, supplier management, risk management, document control / record management, and design control processes. Be sure these processes are appropriately linked so that data from one process feeds the others.
  • Be overly conservative in decision-making processes.
  • Consider patient and end-user safety first.
  • Follow your own procedures.

Yes, if your company has adequately defined processes and procedures according to FDA regulations and you follow them, you should always be ready for a FDA inspection.

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Does the FDA clearance process need an overhaul?

July 8, 2011 By Leave a Comment

There’s been a lot of talk lately about how the FDA clearance process is doing, and whether it is working or not, depending on who you talk to.

Emergo Group did a study in which they found that application times jumped 37% from 2006 to 2010. In 2006 510(k) applications cleared by the FDA took about 96 days, but that number soared to 132 days in 2010.

But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years.

Technology is rapidly changing – and diverging further from current technology, thus making SE (Substantially Equivalent)decisions harder to prove and review. As new technology becomes more ever more divergent from the predicate device, it becomes all the more difficult for the FDA reviewer to agree with the sponsor’s proposed SE strategy, resulting in longer review times. Quite often the 510(k) submitters aren’t providing FDA with adequate scientific data (performance data) and/or SE strategies (appropriate predicate devices). The bottom line result of these trends is longer review times.

Sen. Al Franken (D-Minn.) sent a letter to Dr. Jeffrey Shuren, director at the Center for Devices & Radiological Health at the U.S. Food & Drug Administration, that urged the agency to include industry input on any recommendations the Institute of Medicine makes about changes to the 510(k) process.

CDRH director Jeffrey Shuren said seven new guidelines are now in preparation, covering the following subjects:

  • Device modifications that will trigger a 510(k) (expected in June).
  • Preparing 510(k) submissions (this will include a flow chart indicating what constitutes a new intended use and when clinical data are needed).
  • Emerging technologies (with device-specific guidance).
  • How to conduct clinical studies, including the application of least burdensome principles (due in July).
  • Conducting first-in-human studies.
  • Conditional approvals (due in late October).
  • Factors in making benefit and risk determinations (including a discussion of such issues as disease severity and relation to patients’ tolerance of risk).

I, for one, will be interested to see where the whole process leads us.

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VueMe Allows Patients and Doctors Easier Access to Medical Records

June 7, 2011 By Leave a Comment

MIM software, the makers of the first FDA approved radiology viewing app for physicians, Mobile MIM, just released a medical imaging app aimed directly at patients, and a new cloud service called MIMCloud 2.0, enabling medical imaging to be readily stored and shared securely via a cloud service.

VueMe, the latest offering by MIM software, allows patients to store and share their medical images on the cloud, and interfaces with the physician centered FDA approved Mobile MIM app. The app uses MIMCloud 2.0, a cloud based service that stories all the radiology images — the MIMCloud 2.0 service facilitates exchange of the images from physicians to patients, and vice versa.

Patients can use VueMe and share their images with other physicians who use the MIMCloud 2.0. Instead of a patient having to take a manilla folder or CD with radiology results — they can use a cloud service to store their images, and beam them to other specialists who might not have immediate access to their medical imaging.

Imagine how much easier this will make things for us as patients.  As a self-declared technophobe who doesn’t text and still has an “old fashioned” cell phone that is only really good for actually making phone calls, it does make me wonder if perhaps this “smart phone thingy” might be something I should consider…

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Everyone Agrees the FDA 510(k) Process Needs to be Fixed

June 5, 2011 By Leave a Comment

We came across this article and thought it was worth reposting:

Everyone Agrees the FDA 510(k) Process Needs to be Fixed

May 25, 2011 By Michael Causey Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the FDA’s 510(k) review process, but there’s a tension underneath it all: Industry generally thinks the FDA is way too slow and inconsistent in its 510(k) review process and threatens medical device innovation in the US, and FDA seems to agree that the review process needs some tinkering but isn’t so bad and that much of the problem lay with industry anyway.

While he thanked the Institute for Health Technology (InHealth) for conducting the survey and putting together this forum, FDA Director of CDRH Jeffrey Shuren cautioned that its findings should not be accepted without putting them in some perspective. He noted that the survey was only answered by about 10% of industry, and that those respondents were those who tended to have more complicated than average 510(k) situations.

That said, Shuren acknowledged that CDRH has to do a better job preventing high levels of employee turnover. InHealth’s survey found that one of six or seven reviewers left during the 510(k) review process they were working on, which clearly slows the process and makes life more difficult for medical device companies, especially smaller ones.

Shuren also said FDA and CDRH should and will produce more guidances and will work to address consistency issues. He also said that CDRH should do a better job of identifying those 510(k) applications that won’t be approved as early in the process as possible, therefore spending less time on those.

But Shuren also noted that industry, especially smaller device companies, isn’t doing such a hot job on its 510(k) submissions. For example, a recent FDA study found that about half of all submissions arrived at the agency missing key information out of the gate. He also challenged companies, again especially smaller ones, to take more advantage of pre-submission meeting opportunities with FDA.

The survey is part of “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” a study funded by the Institute for Health Technolog (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life. Bottom-line, it found that the vast majority of respondents (68%) say it is critically important that the regulatory process be predictable, and that 85% said they’d seen “substantive changes” from FDA in its 510(k) review process in the past three years.

The survey offered a number of recommendations it said would improve the process:

Enhance predictability

  • Increase number of guidance documents
  • Timely update of guidance documents
  • Clear and timely communication of new FDA expectations before publication in guidance

Increase process consistency

  • Increase training (particularly implementation of current regulations)
  • Reduce perceived differences in agency follow-through (by enhanced communication)
  • Reduce reviewer turnover

Ensure efficient review process

  • Preparation of clear and complete submissions
  • Eliminate repeat requests of information already provided
  • Timely access to meetings
  • Increased use of interactive review concept

Close gap with international systems

  • Continued harmonization efforts (GHTF)
  • Sharing best practices (particularly on process side), while acknowledging differences in regulatory requirements

Increase attention to specific needs of small companies (while maintaining a level playing field)

  • Improve opportunities for interaction
  • Provide training support in areas where small companies tend to face particular challenges

Monitor effect of process changes

  • Evaluate impact of any process changes through appropriate performance metrics
  • Work with industry to monitor process performance over time

It appears that FDA and industry agree that the 510(k) process is broken. But things get more complicated when they begin to discuss how badly its broken, and what’s needed to fix it.

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