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CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management

February 1, 2012 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Deciphering the FDA is a bit like trying to understand what the old USSR was up to in the days of the Cold War.  In those days, it was called Kremlinology, or the study of a complex, secretive organization.  We need a catchphrase for those of us today who try to figure out what the FDA means when it says something, or what it means when it says nothing, or what it means when it tells you what it means. You get the idea.

The FDA has been talking a lot of late about transparency. Its 2011 initiative is an agency attempt, it says, to open up about how it does business. FDA is accepting comments on it until February 28.  The jury is still out on whether this initiative will accomplish much.

Our latest piece of FDA evidence is CDRH’s 2012 Strategic Priorities.

CDRH devotes the Introduction of the document about looking ahead to patting itself on the back for its 2011 achievements, e.g. its report, “Understanding Barriers to Medical Device Quality,” that reviews the challenges that the FDA and industry face in supporting well‐integrated, best‐quality manufacturing practices and strategies that industry and the FDA can take to overcome these barriers.

CDRH also reminds us that “to complete this work [in 2011] our staff went above and beyond their already demanding workload. This is a remarkable achievement.”

Good to know.

In 2012, CDRH says it will continue to emphasize four priority areas:

  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

CDRH promises in 2012 to “improve” its premarket programs. By April 1, it pledges to begin its Triage of Pre-market Submissions Pilot to “increase submission review efficiency and better manage the pre-market review workload.”

And by the end of the year, CDRH pledges to publish a proposed rule to clarify the circumstances under which it could rely on clinical studies conducted in and for other countries. CDRH also says it will finalize all guidance documents it has issued as part of its overall plan to improve its premarket programs.

We’ll keep an eye on these and other promises throughout the year and report back as FDA hits or misses its own targets.

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Quality Management, Regulatory, Risk Management Tagged With: , , , , ,

FDA Offers Salty Recipe for Increased Food Regulation in 2012

January 3, 2012 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

To salt or not to salt? That is the question. Well, it’s one of the questions.

It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the FDA overplaying its regulatory hand.

We’re not going to settle this controversy here, but some experts suggest you may be able to sprinkle a little salt on your food without feeling guilty about increasing your risk of heart disease and high blood pressure.

However, some say the FDA has gotten too activist and one-sided in its approach to the condiment – and that it’s just another sign that the FDA in 2012 will be more strident with regulatory overreach that won’t help food consumers and will harm food manufacturers.

saltThe FDA is generally following the lead of a 2010 report from the IOM that says salt contributes to serious health problems. The agency is working on a guidance now that would promote ways to reduce salt consumption by Americans in their diet.

“I think the FDA is adding unnecessary bureaucratic layers” that aren’t improving food safety and are in fact making it harder for food manufacturers to do business, says Julie Gunlock, a senior fellow at the Independent Women’s Forum, a non-partisan research and educational institution that seeks to combat what they say is the too-common presumption that women want and benefit from big government. In the case of salt, for example, Gunlock says the FDA is ignoring more recent studies that at least question the strong connection between salt and the health problems.

Gunlock has written extensively about what she calls “the damage” caused by intrusive FDA regulations. She focuses on the harm to food processors and manufacturers, and the role of parents in making dietary decisions on behalf of their children.

For Gunlock, it’s more than just a battle over salt. She sees this issue as just another example of the FDA taking authority away from state regulators and telling consumers what they can eat. “Unfortunately, I think we’ll see tougher FDA actions in 2012 against a food supply chain that is already safe and probably doesn’t need additional regulation like this.”

When trying to predict what will happen in 2012, it’s important to recall that the Food Safety Modernization Act, signed in January 2011, ushered in a new era of increased security measures, processes and controls for food safety officials; most orchestrated by the FDA, notes Don Hsieh, director of commercial and industrial marketing with ADT Security Services. He works to educate brands on how to build a proactive food defense program and how food officials can effectively comply with FDA regulations.

Simply put, the FSMA is the” most significant expansion of food safety requirements and FDA food safety authority in over 70 years, since the original Food Drug & Cosmetic Act in 1938,” Hsieh says.

And FDA is clear on its intent. “The historic FSMA is aimed at transforming our food safety efforts toward prevention and based on risk analysis” said LeeAnne Jackson, PhD, Health Science Policy Adviser, FDA.

Hsieh reminds us that recalls are bad for business, to put it mildly. One of the largest food recalls was the recall of peanut products produced by Peanut Corporation of America. What resulted from this mass distribution of contaminated product were 714 confirmed infections, nine deaths and $1 billion in losses to the United States peanut industry. The Peanut Corporation of America filed for Chapter 7 bankruptcy and its owner and CEO appeared before Congress under Congressional subpoena. Although the cause of the outbreak was one firm and did not involve major peanut butter brands, consumers reacted by avoiding the peanut butter category and sales plunged 25% after the recall announcement. “This points out the importance of not only protecting the food supply chain for your company’s products but being able to prove that your supply chain was not impacted by a specific incident,” he sums up.

But are food processors ready for 2012? Doesn’t sound like it. As Hsieh points out, for most food manufacturers, “documentation is typically done by a person with a clipboard checking off items on a paper check-off list. Given FDA’s mandate of providing documentation of compliance, these documents may not accurately reflect compliance and are difficult to access and compile.”

Looking ahead to 2012, that’s probably an understatement.

 

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Filed Under: FDA Regulated, Food, Michael Causey, Regulatory Tagged With: , , , ,

Companies Struggle to Harness Business Intelligence

December 16, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Business Intelligence (BI), the process of transforming the raw data companies collect from various operations and sources into usable and actionable information, is an often under-utilized and misunderstood tool in the strategic arsenal.

A new white paper from Information Builders by Kevin R. Quinn notes that companies are increasingly leveraging BI software to help them aggregate, manipulate, and display data to further inform their decision-making. Harnessed properly, this can improve the way companies do business if they utilize the proper business intelligence improvement cycle (BIIC).

But many companies fall short of their BI potential for several reasons, including:

  • Users’ skills and desires are misinterpreted.
  • An emphasis is put on the wrong stage of the cycle (plan, improve, measure, and analyze).
  • No information self-sufficiency.
  • No culture of established measurement.
  • Disparate tactical BI solutions gain footholds.

Let’s look a little more in-depth at how these common pitfalls trip up companies.
SKILLS MISINTERPRETED: There are four categories of information workers. Nontechnical business users, who tend to make up 80 to 90 percent of the workforce, business analysts, power users, and IT developers. Quinn says that too many organizations focus all of their BI resources and tactics on the business analysts and power users, this prevents “the majority of users from using the tools and becoming part of the information culture.”

WRONG EMPHASIS: Quinn argues that companies often neglect the first stage, planning or gathering information, in their haste to get to the good stuff. As the old computer adage goes, “garbage in, garbage out.” Planning and collecting information may not be as fun as working with the data, but it’s the foundation for the success of any big BI project.

LACK OF SELF-SUFFICIENCY: A common pitfall when setting the BIIC in motion is that the IT department is relied on as the sole information-producers in the company, while of course they aren’t the only group that generates data. “This causes an imbalance that leads to a heavier burden on IT because as more and more information consumers need information, more and more requests are made of IT.” Making matters worse, IT personnel frequently don’t understand the underlying nature of the business questions that data users are looking to answer, so their responses are often incorrect or incomplete in practical terms.

NO MEASUREMENT CULTURE: We’ve emphasized this before. If there is not buy-in at the top, any initiative is most likely going to fail. No exception here, Quinn says. “If executives are the only people who are about measurement and the improvement of those measurements’ outcomes, the motivation to improve will not be established among the ranks of workers who have the capability to make the necessary changes.”

DISPARATE SOLUTIONS: Quinn writes that many organizations purchase BI tools without a clear strategic plan for using them to truly make changes within the organization. When reports are generated at the behest of a Big Cheese, for example, rather than being part of a bigger BI plan, key reports and key information is often locked in figurative silos without contributing to a smooth-flowing BIIC.

Quinn advocates a simple method of information access and distribution along with open communication within an organization to ensure that everyone understands the value of BI and why an intelligent BIIC is a critical component of success in today’s marketplace.

Editor’s Note: To read the full white paper, click here. Note: Registration is required.

 

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Lilly CEO Calls on FDA to Lighten Up

November 8, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA has to speed up adoption of a “Benefit-Risk Framework” to improve decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company.

Speaking at recent industry conference, the CEO of the drug giant called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

“The stakes are high,” Lechleiter said. “The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress.”

The FDA appears to be a bit on the defensive here. It recently issued a report touting its record approving drugs it says demonstrates it isn’t stifling innovation at all thank you very much.

The backdrop to this battle is the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V. Originally enacted in 1992, PDUFA and its iterations set the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lilly’s Lechleiter stressed the importance of a non-partisan course for reauthorization. “As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics,” Lechleiter said. “As Congress considers reauthorization next year, we hope to see a ‘clean’ bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties.”Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.

Lechleiter offered five key characteristics of a “state of the art” regulatory approval system:

  1. Timely – “There are far too many conditions for which therapy is inadequate or nonexistent. We need a system that is not only effective, but efficient as well.”
  2. Predictable – “The system must be predictable in its judgments, its decisions, and the criteria on which those decisions were based – whether scientific, ethical, legal, etc.”
  3. Consistent – “The system must be consistent across review divisions using standardization and repeatable processes – so that an innovator clearly understands the regulatory requirements and so that institutional learning can be harnessed to replace time-consuming one-off learning by review groups and division.”
  4. Transparent – “The system needs to be transparent in its judgments and criteria so [stakeholders] understand the rationale for its decisions.”
  5. Scientifically rigorous – “This requires scientific expertise within the agency – or access to the expertise – that understands, engages in, and influences the constantly evolving external scientific environment and ensures that standards are up-to-date.”

Lechleiter also discussed ways to strengthen a medicine’s benefit and lower its risk, including calling for greater emphasis on improved outcomes for individual patients, through the development of tailored therapeutics.

“From the point of view of patients and their doctors, a tailored therapy will provide a better benefit/risk trade-off, because they can have a higher degree of confidence that it will work effectively and with minimal harmful side-effects relative to the benefit obtained,” said Lechleiter. “From a value-for-money standpoint, tailored medicines should also reduce the heavy costs associated with non-responders. In other words, payers will get what they are paying for.”

Cry havoc and let slip the dogs of war. This one isn’t over by a long-shot.

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Filed Under: FDA Regulated, Michael Causey, Pharma/Biotech, Regulatory, Risk Management Tagged With: , , , ,

FDA Promises ‘Sea Change’ in Food Regulation

November 2, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The new mantra for food manufacturers better be prevention, prevention, prevention according to current and former FDAers commenting on the January 2011 passage of the mammoth Food Safety and Modernization Act.

“This law represents a sea [of] change for food safety in America, bringing a new focus on prevention…” FDA Commissioner Margaret Hamburg says.

But former FDA Commissioner of Foods Dr. David Acheson takes it further in a new white paper from Plex Online. The new law “will result in significant changes for FDA-regulated food manufacturers and processors.” FDA’s emphasis on prevention will require registered facilities to develop and maintain a written food safety plan, for starters, Acheson stresses in a new white paper “Food Safety plans: New Requirements for Registered Facilities.”

As we’ve blogged before, most registered food facilities will be required to develop a clear, detailed safety plan that documents the facility’s:

  • Prerequisite programs are in place to ensure food is produced in a safe and sanitary manner;
  • Hazard analysis that identifies all potential risks throughout processing;
  • Preventive controls that are implemented to mitigate risks;
  • Monitoring of preventive controls to ensure they are properly implemented;
  • Verification that the preventive controls have the intended reduction in risk; and
  • Re-analysis of the hazards and preventive controls when there are significant changes in the process or every three years.

Acheson, now with Leavitt Partners, notes that regulated entities must soon be “able to quickly access records and demonstrate compliance with the food safety plan requirements.” They’ll also be expected to have “implemented a robust food safety program” if they want to maintain a position as a food safety leader.

He advises regulated entities to develop well-documented safety plans with strong monitoring procedures and corrective actions, for nine key areas:

  1. Facility Information: Facilities will need to document a description of the food, the methods of distribution and storage, the intended use and intended customer for all products produced.
  2. Prerequisite Programs: These programs will require a written plan, established monitoring procedures, established corrective action procedures, and an established recordkeeping system.
  3. Hazard Analysis: Facilities will be required to conduct and document these to identify potential product-related hazards, including biological, chemical, and other hazards such as terrorism.
  4. Preventive Controls: Once identified, each hazard must be evaluated to determine the significance of the hazard if it isn’t controlled, the likely occurrence of the hazards, and if it constitutes a “critical control point” that must be addressed.
  5. Monitoring: Each critical control point must be then monitored to ensure compliance with the critical limits.
  6. Corrective Actions: Beyond on-going monitoring, facilities must establish and document procedures for taking proper and effective corrective actions when critical limits aren’t met.
  7. Verification: Facilities will then need to verify that the preventive control and critical limits result in the intended control and reduction of hazard.
  8. Record-keeping: The new legislation authorizes the FDA to request access to a regulated entities’ Food Safety Plan. Each entity must establish a record-keeping system that documents their hazard analysis, critical control points, monitoring, verification, and corrective action plans and follow-up.
  9. Re-analysis: facilities are required to conduct one of their food safety plan and hazard assessment whenever they implement significant changes or every three years.

It will take some time for the FDA to decide exactly how it will enforce the new law, and its interpretation will clearly have some impact on food manufacturers and other regulated entities. But it’s equally clear that the new law means big changes for companies that make food for a living.

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Filed Under: FDA Regulated, Food, Michael Causey, Quality Management, Regulatory Tagged With: , , , ,

Former FDAer: ‘Sweeping’ Food Regulations Will Challenge Entire Industry

October 20, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The most sweeping food regulation since the days of Franklin Delano Roosevelt is about to catch some unsuspecting companies off guard, warns former FDA Associate Commissioner of Foods Dr. David Acheson. “Companies need to update their compliance systems to meet a new mindset and new regulations,” he stressed.

The Food Safety Modernization Act, signed into law in January, will go into effect in stages in the next few years. The final rule is expected to be enacted in July 2012, with a ramp up time for companies to comply. It’s worth noting that, unlike its work with, say, 21 CFR Part 11 and eMDR, the FDA has in fact hit every regulatory deadline it has given itself. “That doesn’t give you very long to understand and navigate the change,” Acheson said.

But as with pharma and medical device industries, the bigger food companies tend to have a jumpstart in terms of compliance when compared with smaller companies, notes Plex’s Executive Vice President, Tom Mackey. Big companies had a hand in writing the law and are generally supportive of its provisions, he adds.

FDA, reacting to some high-profile recalls with cantaloupes, peanuts and other food products, is now preaching a mantra of “prevention, prevention, prevention,” Acheson said this week at a Webinar sponsored by Plex Online.

Acheson, now managing director food and import safety with Leavitt Partners, warned food industry players that “protecting the brand today is different than it was five years ago…and these new regulations are just icing on the cake.” New challenges for the food industry include higher consumer expectations and more aggressive social media that can damage a brand almost instantly.

We’re in a new world of global risk and supply chains, Acheson warned. Food companies that don’t get it, are going to get it from the FDA.

While he doesn’t expect FDA food inspections to increase for at least another year or two domestically, they are already on the rise internationally. He noted, too, that FDA inspectors today are focusing more on how well companies have a handle on CAPA and root cause analysis. “The FDA really expects you to understand what went wrong,” he said.

For example, in a typical inspection, an FDA inspector will now ask to see your food safety plan. He won’t read it cover to cover, but he will focus on a particular point, then ask you to demonstrate what’s gone wrong in your system in the last six months and ask you to show your root cause analysis capability, too.

“This is a great way to inspect, and the FDA has a heavy emphasis on verification and knowing that your plan is working,” Acheson said. All components must be continuously documented.

Oh, and expect more warning letters and recall notices, too, as a result of the Act and FDA’s new emphasis.

“It’s a heavy lift [to comply] but there are many ways to make it easier, including staying informed and using technological innovations” to get a better handle on your supply chain and your operations, he said.

But don’t get complacent just because you have some time before you need to comply, he suggested. Instead, use this time to get ahead of the curve.

Start by identifying a team in your firm to spearhead compliance, conduct a gas assessment, determine the best way to close those gaps, examine if your current business practices conform to these new regulatory demands, set priorities based on risk and resources, and establish a system to stay informed internally and one that can be used to demonstrate to FDA inspectors that you are on top of it.

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Filed Under: FDA Regulated, Food, Michael Causey, Regulatory Tagged With: , , , ,

Medical Device Industry Warily Eyes More FDA Reorganization Plans

October 10, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

That sound you heard last week was the device industry sighing and maybe even applauding lightly when the FDA announced  it was seeking the public’s input on a plan to identify and harness a web of outside experts who may help it speed device approval.

As Reuters reported, FDA formed a pilot committee of experts, which will run through December 30 and expand the pool of vetted sources the agency already has on tap. It’s all part of the FDA’s effort to reform the 510(k) medical device review process. Some say the agency isn’t tough enough in protecting the safety of device users; others say the agency is stifling innovation and sending more jobs overseas.

Device manufacturers we spoke to were guardedly optimistic about this and other recent FDA moves. “We support the creation of such a network, providing that the FDA ensures that the experts do not have any personal or professional ties or conflicts of interest with the products / manufacturers / specific device industries they oversee,” Kelly Roman, Vice President at Fisher Wallace Laboratories, told us.

“We are aware that current Panel members that the FDA works with on PMA and reclassification matters may have these types of ties and conflicts,” Kelly continues. “It is difficult to retain top experts who have no vested interest in the fate of the industries they oversee, but ensuring that the process is completely free of bias is essential to the FDA’s mission and to public health.”

She suggests that, as with Panel members, FDA should “provide the full professional biographies of network experts. “ She also called on the agency to provide a forum by which the public may raise concerns over potential conflicts of interest on a case by case basis, and provide some process by which these concerns are officially addressed.

“This will help provide transparency and resolution to conflicts of interest that will inevitably arise. As of now, there is no clear, prescribed way to address such issues.

But Charlie Chi, Ph.D., former CEO and co-founder of OtisMed (now part of Stryker Orthopaedics), is a medical device industry entrepreneur and inventor flat out thinks it’s a bad idea for the FDA to get involved in new medical technologies.

Chi doesn’t think any company would want the FDA to get involved in every step of the product development cycle. In addition, he thinks it would take longer and be more costly for companies to develop new medical devices even though the approval process might be faster.

Chi noted that most U.S. companies are now going to Europe/Asia first to launch their new products because the approval process is quicker and less stringent than in the U.S. Yet, the failure rate is actually less than here in the U.S. He thinks the FDA should follow a review and approval process similar to other countries around the world.

Doug Mowen

Doug Mowen, Accenture

Accenture’s Doug Mowen feels the pain of both sides and urged the medical device industry to take a “wait and watch” approach. “There has been so much noise around FDA and these issues, but I believe the FDA has now heard everyone loud and clear.” He and his team work with medical device firms to handle 483s and other FDA-related dealings.

Doug sees some reasons for optimism because the FDA does seem to finally understand the medical device industries concerns. “If the FDA is able to reform a few things in the 510(k) process and make it more transparent, that will be such a positive thing.”

With over 15 years of experience in the Life Sciences industry, Doug has worked broadly across the medical technology industry, assisting major MedTech companies with compliance in key areas including emerging markets, supply chain, and pricing and customer profitability. Most recently Doug developed a research paper “Achieving High Performance: Reinventing Medical Technology for a Dramatically Different Future,” addressing how global regulatory issues are changing the overall business landscape for MedTech.

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory Tagged With: , , , ,

IOM Report Calls for Gutting Current 510(k) Review Process, Angers Everyone

August 3, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Tyra Banks aside, not many 35 year olds look as pristine and buff as they did in younger days.

But if the new Institute of Medicine (IOM) report has its way, the FDA’s 35 year-old 510(k) process should be put out to pasture entirely.

I suppose there’s something to be said for the fact that IOM’s controversial new report seems to have made almost everyone mad.

FDA is reportedly not happy and surprised that it calls for scrapping the current 510(k) system.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said industry isn’t happy with it, either. “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

Ulb goes on, “Numerous academic studies have shown that the 510(k) process is overwhelmingly safe. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance. It even goes so far as to say that further investment in 510(k) process improvements would not be ‘a wise use of FDA resources.”

But IOM’s report seems to have surprised everyone with its stark view of the situation.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effective­ness of moderate-risk devices and, furthermore, that it cannot be transformed into one,” the report says.

IOM believes “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

In other words, junk it. Start over.

Has the FDA’s 510(k) process hindered innovation (as much of the medical device industry maintains), or has it struck the best balance between protecting patients and spurring new ideas?

Sorry, IOM punted on that one. “It is unclear—and the committee concludes that it is indeterminable, given current information— whether the 510(k) process over the last 35 years has had a positive or negative effect on innovation. To answer this question, the FDA should commission an assessment to determine this effect.”

In other words, do another study.

Respected industry attorney and Hogan Lovells Partner John Smith tells us, “the report is extremely disappointing given the time and effort that has been dedicated to this process. The assumptions underlying the IOMs conclusions are fundamentally flawed and those conclusions are vague and highly questionable.”

Specifically, he faults the IOM report for saying the 510(k) process does not evaluate safety and effectiveness. “This is simply not true in FDA’s application of the 510(k) paradigm to new medical devices. Although the standard for clearance is ‘substantial equivalence,’ the agency routinely integrates an evaluation of both safety and effectiveness into its substantial equivalence determinations. In other words, the IOM analysis lacks a ‘real world’ perspective and appears to have relied upon on a very conservative reading of the Federal Food, Drug, and Cosmetic Act, and its implementing regulations to reach this conclusion.”

IOM says scrap the 510(k) system, but some say scrap the IOM report.

“The Institute’s primary conclusion that the 510(k) process should be abandoned completely ignores the considerable debate that lead to its creation and the successful applicable of the 510(k) paradigm over 35 years,” Smith says. “No specific, systemic shortcomings that would justify such a radical restructuring were convincingly identified. Simply put, establishing the 510(k) paradigm was a thorough, thoughtful process and the process served both FDA and industry well since its inception. The Institute also fails to offer concrete recommendations as to potential alternatives, likely reflecting how difficult it will be to improve on the existing 510(k) paradigm.”

Watch the IOM’s webcast unveiling the report here.

Comment period ends September 30. To comment, go here:

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory Tagged With: , , , ,

Book Review: Former FDA Inspector Calls for Revitalized Agency, Focus

August 1, 2011 By 1 Comment

Patrick Stone, President, TradeStone QA

In a book he says is neither a “toasting or a roasting,” former inspector Patrick Stone clearly loves the FDA he worked at from August 1998 until March 2011, but hates some of what he’s seen happen at the agency.

“Bubble Gum Badge” is invaluable for regulated companies because, among other things, it shows the importance of gauging the human side of FDA inspectors. As Stone notes, they have different approaches and interpretations to how they do their work, including what they look for on inspections and what they consider problems. It’s incumbent on regulated companies to have best practices in place, but also to be prepared to explain their rationale to inspectors.

“FDA investigators, the good ones, at least, can read individuals like a book; and your lack of experience is on the front page. Good leaders listen to the experts in the field and are willing to learn from a subordinate,” Stone advises higher-ups at regulated companies. His book is full of such practical, nuts and bolts advice.

Bubble Gum BadgeStone also calls for both industry and the FDA to do a better job with electronic data integrity and electronic record keeping. There’s lots of room for improvement on both sides. He lays out several areas where each needs to raise the bar, but for industry it boils down to taking it seriously, using common sense, and not trying to hide violations. For the FDA, it’s about practicing what it preaches, and issuing some vastly overdue new guidances for 21 CFR Part 11, among other electronic record areas. Fuzzy FDA directives aren’t helping anyone, Stone maintains.

This isn’t a rough hatchet job, but more of a carefully considered critique of an agency Stone loves, but wishes could be better. “I am not a disgruntled employee… I have nothing but respect for the field investigators, laboratory staff, support staff, and frontline workers as well as the center reviewers.”

I hope some current senior FDA staff read this book and take it to heart.

Click here to purchase his book.

Connect with Stone, and to read a book excerpt visit http://www.bubblegumbadge.com or email him at patrick@tradestoneqa.com.

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Filed Under: FDA Regulated, Michael Causey, Quality Management, Regulatory Tagged With: , , ,

FDA to Medical Device Industry: Slow 510(k) Process is Your Fault

July 22, 2011 By 1 Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA is going Peter Finch in Network on us. They’re mad as hell, and they aren’t going to take it anymore.

Hit by recent studies claiming the 510k review process is slowing and that the agency is largely to blame, the FDA has struck back with its own study that basically say the medical device industry is the villain because it does a lousy job with its submissions.

For those keeping score at home, the FDA’s new study essentially lays a bit over 80% of the blame on industry, and says it’s responsible for some of the rest.

Two separate analyses of AI Letters were conducted in the FDA study: one to assess incoming submission quality (Cohort 1) and one to assess the drivers of the increasing numbers of review cycles (Cohort 2).

“Results indicate that 83% of the submissions in Cohort 1 and 82% of the submissions in Cohort 2 contained at least one deficiency related to quality, as defined below. The remainder of the submissions in each cohort had deficiencies that fell outside the conservative definition of quality used in this report. In Cohort 1, 52% of these quality issues involved the device description, meaning the sponsor either did not provide sufficient information about the device to determine what it was developed to do, or the device description was inconsistent throughout the submission. Like Cohort 1, the Cohort 2 analysis shows that roughly 50% of submissions that received at least one AI Letter lacked an adequate device description.”

But former FDA inspector (and my fellow AssurX blogger) Patrick Stone isn’t buying the FDA’s interpretation and thinks they are leaving a few key elements out of its analysis. “The stats will show that there are many thousands of submissions in line for review or audit.  More than FDA can handle…that is one issue,” Stone notes.

Another problem: “The FDA device Experts can not readily keep up with the technology so there is the on the job training for FDA at inspection time and slow center review cycle.”

Stone’s solution? “FDA needs to provide comprehensive BIMO device guidance and cradle to grave expectations.  The game gets changed half way through the development cycle so that what was compliant four years ago is now not.”

I’m not sure how much it will help, but the FDA is getting support from some Democrats in DC, who also question some of the studies critical of the agency.

This battle ain’t over. Watch this space.

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