December 8, 2016

Independent Study Finds FDA 510(k) Review Process Has Gotten a Lot Slower

Michael Causey, Editor & Publisher,

Well, this is getting interesting.

For the past several months we’ve had relatively partisan folks on each side (device industry vs. FDA) either saying the 510(k) process wasn’t doing so badly (the FDA) or that it was too slow and restrictive of innovation (the medical device industry) or suggesting that the review process was slowing because the other guy was screwing up.

And while a number of industry-sponsored studies have been critical of the FDA for a slower review process, FDA supporters (well, mostly, the FDA) have shot back that studies funded by industry tend to “discover” what industry wants discovered.

Now we’ve got a very raw data type of new study survey from the Emergo Group that is not funded by either side and was conducted by a group that maintains it has no dog in this fight. Noting that the FDA’s overall track record isn’t that bad in many ways, the Group’s Stewart Eisenhart did note that the numbers show clearly it now takes a lot longer to get a 510(k) review than it used to…and he’s not surprised.

Emergo’s analysis finds 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.

More than 53% of 510(k) submissions from January 1, 2006, to May 23, 2010, were cleared within three months, and more than 80% made it through within six months, according to the report. Eisenhart said the FDA should feel proud of its record in that arena, at least.

More than 80% of all companies submitting a 510(k) are able to obtain FDA Premarket Notification clearance for their medical device within 6 months.

Hogan Lovells Partner John Smith an expert on navigating the FDA for medical device firms, says the “new FDA” is a lot tougher for medical devices companies to work with when it comes to 510(k)’s.

Example: the FDA has raised the bar on data requirements for devices it wouldn’t have held to that standard in the past. He recently worked with a medical device that the FDA had never before demanded patient study data. But this time, it did insist the medical device company conduct a 60-patient study. “It slowed the process,” he told us last week (June 23).

“I think the FDA reviewers ask a lot more questions than they did, say, ten years ago,” Emergo’s Eisenhart told us June 23. “It’s difficult to say this is all the FDA’s fault, but the medical device industry is definitely under more scrutiny from reviewers now” during the 510(k) process.

Dealing with the FDA is “a very sobering experience” for small and mid-size companies that may think they know what the FDA wants, but learn that some of the rules have changed, Smith said. His firm has worked on about 300 510(k)’s in the past year.

Emergo works with medical device firms of all sizes, but the bulk of their 510(k) consulting work is with small to mid-size shops. “We have no agenda,” Eisenhart stressed.

So given today’s tough regulatory climate, does Eisenhart have any advice for a medical device firm about to embark on a 510(k) with the FDA? “Be prepared to backup all that you submit, be prepared for more questions, and know that if you are a repeat applicant, it is not the same process anymore.”



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

Michael Causey, Editor & Publisher,

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.




Senate 510(k) Hearings Flawed, Device Attorney Says

Michael Causey, Editor & Publisher,

Calling the recent GAO charges that the FDA is putting patients at risk by approving too many devices through the 510(k) process “silly and off base” leading medical device industry attorney Jonathan Kahan, Co-director of law firm Hogan Lovells’ Medical Device practice which represents about 700 medical device firms, says the current climate of misguided regulation is as bad for device firms as it was in the early 1990s.

Small device firms in particular are struggling to understand FDA’s confusing regulatory posture, and many are going out of business as a result, Kahan told us April 18. Kahan  has been practicing in FDA law for 35 years, and specifically focuses on assisting medical device companies navigate the FDA’s regulatory process.

During high-profile Senate  hearings last week the FDA heard from lawmakers that no one is especially thrilled with the agency’s performance in this arena  As reported in the Minneapolis Star-Tribune,  “Nobody is particularly happy with the FDA,” Sen. Bob Corker, R-Tenn said at the hearing.

Kahan acknowledges that some medical devices fail (“and NASA can’t always make a shuttle that doesn’t blow up”), but he stressed that the numbers are very low and that the GAO report wouldn’t address those failure problems anyway. “The problems occur more in the manufacturing side and not as a result of the 510(k) process,” he said.

“Congress and the White House have an astounding lack of understanding of this issue,” Kahan added. “The GAO emphasis is totally missing” the point.

Kahan stressed that the biggest issue is FDA inconsistency in its regulations and enforcement policy. He was echoed by at least one speaker at last week’s hearings.

The medical device industry is concerned that CDRH procedural and management problems have slowed medical device innovation. In his testimony last week, David Nexon, Senior Executive Vice President of the Advanced Medical Technology Association, criticized that there are, “inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology.”



Here’s an Idea: FDA Launches Device ‘Innovation Pathway’

Michael Causey, Editor & Publisher,

It sounds a bit like some 1960s futuristic ride at Epcot Center, but the FDA gamely today unveiled what it calls the “Innovation Pathway,” which is a fancy way of saying it’s a priority review program aimed at advancing breakthrough medical devices. As the agency seeks comment on how to use the “Pathway” more often, it also announced the first device submission: a brain-controlled, upper-extremity prosthetic.

The new program is highlighted in a report on the FDA’s website. It’s part of a broader effort from the Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus.

The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science. Proposed actions include:

  • establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;
  • creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and
  • using more device experience and data collected outside the United States.

In addition, CDRH intends to engage in formal horizon scanning – or what is calls “monitoring medical literature and scientific funding in a systematic way to predict where technology is heading.” CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.

Formal horizon scanning? Didn’t science fiction great Philip K. Dick write something like that a few decades back? I’m thinking Minority Report or Blade Runner (the book is called “Do Androids Dream of Electric Sheep?” for you purists).

FDA LabsI suspect many in the medical device industry wish the FDA would focus more on the here and now when it comes to spurring medical device innovation. Namely, improving its 510k process so American medical device firms aren’t forced to play catch-up with their competitors in the European Union, as we’ve blogged about before.

But at today’s press event announcing the “Pathway,” CDRH Director Jeffrey Shuren accentuated the positive, “Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions…CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”

FDA even supplied some photos of its labs.


In today’s announcement, the FDA said the Pathway includes these features:

  • products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
  • selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
  • products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.

Maybe it’s just me, but the creation of a new “oversight body” doesn’t automatically sound like it will speed up the process.

At any rate, the FDA said it could ultimately conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

I don’t think many people playing a free association game would link “FDA” with “innovation” just yet, but let’s make like Buzz Lightyear here with a little Formal Horizon Scanning of our own and cling to optimism in the face of any discouraging facts.

Hooray for the Innovation Pathway!


‘Crescendo of Complaint’ Calls for FDA to Improve Medical Device Regulation

Michael Causey, Editor & Publisher,

Medical device recalls in Europe and the U.S. come at about the same rate, though the approval process in the U.S. takes significantly longer, says a controversial new study sponsored by device trade group AdvaMed. The report was prepared independently, however, by Scott Davis, Erik Gilbertson and Simon Goodall of The Boston Consulting Group.

The report examines the rate of safety recalls for medical devices in Europe from 2005-2009 and compares them with the level of similar recalls in the U.S. The study focused on those products recalled because of significant health risks and found an average recall rate in Europe of 21 per year, compared to the tens of thousands of devices on the market. That’s almost identical to the rate of equivalent recalls in the U.S., according to their analysis of the data.

While the FDA takes a lot longer to review medical devices, the evidence suggests the EU basically does just an effective job protecting patients in a lot less time, AdvaMed’s Ralph Ives Vice President, Global Strategy and Analysis, told us exclusively in a Feb. 1 interview.

We’ve blogged a bunch about the sometimes cantankerous back and forth between the medical device industry and the FDA regarding the regulation of medical devices, especially the 510(k) process. Both sides have shown surprising heat in making their cases and defending their positions.

This new report’s findings do beg several questions, however.

First, does the FDA over regulate medical devices compared to Europe?

Yep, says David Nexon, senior executive vice president and head of AdvaMed policy. “What’s surprising,” he told us in an exclusive interview Feb. 1, is how much the FDA’s performance has “slipped in the last four or five years, and especially the last two or three. We’re hearing a crescendo of complaints” from industry about increasingly slow responses and inconsistent review policies from the FDA.

“This initial assessment of comparable recalls between the US and Europe does not suggest that different approval processes, and earlier approvals, in Europe come at a cost in terms of patient safety,” claims the AdvaMed/BCG report.

Second, are medical device companies releasing products in the EU faster than in the US? The report says yes. “As device approvals have become increasingly challenging in the US there has been a shift toward companies obtaining approval of their most innovative technologies in Europe first, often years before the same technologies are approved in the US.”

That lag times averages about two to three years, Nexon told us. That means patients in the EU are often getting leading-edge devices well before American patients requiring the same care.

FDA data shows the time it takes to review and approve a product in the U.S. has increased substantially in recent years. Today’s report comes out less than two weeks after a Medical Technology Innovation Scorecard by PwC showed regulatory approval times in the U.S. now rank close to the bottom – seventh out of the nine competitor nations that PwC studied. And a recent study funded by AdvaMed but conducted by Stanford professor Dr. Josh Makower reported that on average FDA reviews for 510(k) products take two years longer from the point of initial communication with the regulatory agency than reviews for similar products in Europe. For PMA devices, the gap climbs to more than three and a half years.

We’ve heard some isolated rumblings that the new report doesn’t make a perfect “apples to apples” comparison between EU and FDA, but AdvaMed’s Janet Trunzo, executive vice president of technology and regulatory affairs, told us they are very confident that the comparisons are apt.

“The study did an elaborate data cleaning to make certain comparable devices were being compared,” stressed Nexon. “We haven’t gotten any FDA response yet to this study,” Nexon notes. But he’s encouraged that the FDA “at the top seems to know they have a problem” in their performance. “That’s a real positive,” he adds.

Looks like the ball’s back in the FDA’s court.


FDA Rolls Out Aggressive 510(k) Revision Plan

Under attack from consumers for being too lax and from industry for being too stringent, the FDA today unveiled its controversial and long-awaited 510(k) plan it hopes will improve the review process for “certain innovative, lower-risk medical devices.”

Like most government wonks, the agency focused on numbers from the start. Today’s plan contains not 24 or 26, but 25 specific actions it plans to take. Those include:

  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

An ambitious rollout plan is outlined here:

Publicly, most device industry groups are cautiously praising the FDA, with a few exceptions, such as AdvaMed’s Stanford University report. Privately, most device makers tell us FDA is going overboard and will stifle medical innovation.

Today’s actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), told reporters in a conference call this afternoon.

Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process — industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway.

Reported by Michael Causey – you can read his other posts here.


FDA 2011 Regulatory Climate: Cloudy, With a Chance of More Regulation

Michael Causey, Editor & Publisher,

Last year we put on our weather forecaster’s hat and called for greater FDA enforcement of medical devices in 2010. For the most part, I’d argue we got that right.

Unfortunately for us amateur prognosticators, 2011 is looking cloudier – and weirder. While the FDA has sent some signals that it intends to take enforcement matters more seriously, we have also seen the agency behaving a bit oddly when it comes to its efforts to improve 510(K) regulation and make the agency more “transparent” to John Q. Public.

Let’s take a look at some of the FDA’s Greatest Hits of 2010:

  • The Kids Think They Are Alright: It’s not the year’s biggest issue by a long shot, but the dismissal of several senior media experts and their replacement by Young Turks with little or no FDA-related experience does suggest the FDA may be getting more political and less interested in real science. While hope springs eternal, this doesn’t bode well for an open or especially skilled department in 2011.
  • Cloudy Transparency: A clumsy FDA attempt to tout transparency when no one was watching oddly-timed “transparency” news release from the FDA isn’t really the best time to tell the world you want to open up and apply tougher metrics on your performance. Still, that’s just what the FDA did with an August 31, 2010, release touting its new “organizational performance management system” called FDA-TRACK. It promised to monitor FDA accountability and transparency and will monitor more than 100 FDA program offices through data from key performance measures established each year. Just don’t tell anyone.
  • CDRH Likes Itself: For the year, CDRH gave what kids in school would consider a B+ with an 86% completion rate in a new report, the Center for Devices and Radiological health says it accomplished 86 percent, or 92 of 107 actions it pledged to complete in Fiscal Year 2010.
  • 510(k) Regulation is Either Onerous or Marvelous: An AdvaMed funded report from Stanford sparked controversy –and a testy FDA response – when it concluded that device companies pay a heavy price in terms of time and money when it comes to FDA compliance. That’s the well-researched and well-argued thrust of the big study from Stanford that also said American firms and consumers were at a disadvantage compared to those in Europe. The debate on the cost and hurdles for medical device regulatory compliance will certainly continue into 2011.
  • Hamburg Talks Tough. A new FDA report suggests the agency is trying to get some of its regulatory swagger back after budget cuts and brain drains hampered much of its work in the George W. Bush years. In October, FDA Commish Margaret A. Hamburg M.D., said the agency proposes to build on what it calls the success of the Critical Path Initiative and other projects by leading an effort to advance regulatory science through its new Regulatory Science Initiative.

All in all, it looks like the FDA is still struggling to find its identity as we enter 2011. Will it become a more aggressive, strident regulatory agency? Will it slip back into relative lethargy? Worst scenario: Will it become more aggressive with less experienced inspectors and other professionals at the helm?

Watch this space in 2011.


AdvaMed Tries Public Diplomacy to Handle Swinging FDA

Michael Causey, Editor & Publisher,

One of the most entertaining aspects of those great Rocky boxing movies is the impossible number of punches fighters land in each round. In Rocky Balboa , for example, the challenger throws more than sixty punches in the first round…that comes out to a punch about every three seconds.

As we’ve been showing in some recent blogs, it appears AdvaMed and the FDA are looking to start their own fighting franchise.

When FDA’s Jeffrey Shuren, director of the Center For Devices and Radiologic Health, recently labelled AdvaMed’s 510(k) study “highly flawed,” here he landed a pretty good hook to the jaw. But AdvaMed got up off the canvas today (Dec. 2), though it went more for a diplomatic Tai Chi approach by trying to take the FDAs energy and moving it in another, less industry-threatening direction.

“AdvaMed is pleased that Dr. Shuren’s remarks are a strong statement recognizing the need to improve CDRH’s effectiveness in supporting innovation and with his commitment to an interactive premarket review process that is predictable, consistent, transparent and timely,” commented AdvaMed President and CEO Stephen J. Ubl.

Ubl said Shuren’s comments “reflect support for common sense 510(k) reform recommendations that will address some of the most critical problems at the Center – recommendations for enhanced guidance and standard operating procedures, greater transparency and clarification of review requirements, and increased training for Center staff and industry.”

AdvaMed’s Ubl strained himself to put a good face on FDA’s tough public reaction to its Stanford Survey. “As the reform process moves forward, we look forward to continuing to work cooperatively with Dr. Shuren and his staff. There are a number of areas where broad support for needed changes exists. These points of agreement should serve as a foundation for future reform efforts. Such an approach would improve the 510(k) process and would avoid proposals that could have a negative impact on innovation and patients.” So, who would win in a computer fight? Rocky or Bruce Lee? Guess we’re going to find out.


The Empire Strikes Back: FDA Blasts New 510(k) Study

Michael Causey, Editor & Publisher,

It may not be quite as epic as the intergalactic battles in the Star Wars saga, but it’s still heating up to be a pretty juicy fight.

This week, the FDA took the relatively unusual step of publicly and directly challenging an interesting and controversial study conducted by Stanford University but funded by The Advanced Medical Technology Association (AdvaMed) that says FDA regulatory policies are stifling medical device innovation and costing those companies much more than counterparts in Europe.

Pointing to what he called “several significant flaws,” FDA spokesman Dick Thompson said the study “compared apples to oranges because companies come to the FDA earlier in the device development cycle than they do in the EU,” as reported by Devices & Diagnostics Letter.

FDA also criticized what it characterized as a low response rate for the study. Some 20 percent of the more than 1,000 companies contacted actually responded. Thompson suggested the relatively low response rate could have produced biased results.

Not surprisingly, medical device folks we’ve spoken with by and large heartily endorse the AdvaMed/Stanford report’s findings. Consultants and former FDA inspectors also tell us it’s generally on target, though they are less vehement than medical device personnel.

The study was released Nov. 18. AdvaMed President Stephen Ubl that day commented, “this report is a wake up call for those who want to promote medical innovation and preserve American jobs.” He also said the study “shows that timely patient access to new technologies and industry competitiveness are being held back because of inefficiencies that must be addressed. We urge FDA to review the findings of this study and we are committed to working with them to address these issues.”

Well apparently FDA did review them, and came to quite a different conclusion.


In September, AdvaMed released a study it said demonstrated the “ strong safety record of FDA’s premarket review process for low- and moderate-risk devices. That study, conducted by the research firm Battelle Memorial Institute, found that of the nearly 47,000 medical devices cleared by FDA through the 510(k) process since 1998, only 0.16 percent were involved in a serious recall event.

“This study highlights the remarkable safety record of FDA’s 510(k) process,” said AdvaMed Chairman James V. Mazzo, president of Abbott Medical Optics.

AdvaMed is on record saying it backs recommendations regarding increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale could address these deficiencies that result in delays and inconsistencies in the program.


Earth to FDA: Medical Device Compliance is Really Expensive

Michael Causey, Editor & Publisher,

Sometimes it takes an independent study to confirm what everyone kind of already knew or suspected: Device companies pay a heavy price in terms of time and money when it comes to FDA compliance. That’s the well-researched and well-argued thrust of a big new study from Stanford.

The survey of more than 200 medical device companies found some sobering results. For starters, FDA turnover presented many of them with a hassle: 44% said they had to deal with the departures of sometimes key FDA folks handling their premarket approval. And more than a third, or 34%, said that appropriate FDA staff was not present at key meetings.

Makers of high risk devices seeking premarket approval said it took them an average 54 months from first communication with the agency to getting approval. In Europe, that average is 11 months.

Now let’s talk money.

The average cost to bring low-to-moderate risk 510(k) products to market was $31 million, reported medical device companies. The FDA accounted for a whopping $24 million of that via direct and indirect compliance activities.

Higher-risk devices reported a sticker price of $94 million, with $75 million of that linked to the FDA.

“For U.S. companies, these mounting costs are unsustainable in a venture-backed industry where less than one out of four medtech start-ups succeed, 50 percent of all reported exits, [such as an acquisition or initial public offering] are less than $100 million, and the total pool of available investment capital is shrinking.”

In the 1950s and early 1960s politicians made a lot of a so-called “Missile Gap” between the United States and the U.S.S.R. Today, this report points to a “Device Lag” between the U.S. and Europe. “In some cases, the device lag [between US and European approval] reached up to 70 months.”

In the coming weeks, we’ll get some more experts to weigh in on this issue. Stay tuned.