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Industry Applauds FDA Moves to Speed 510(K) Review Process

February 19, 2013 by 2 Comments
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA hopes a new guidance will provide a “more efficient approach” to making sure that safe and effective medical devices reach patients more quickly. Broadly speaking, industry generally supports the new guidance, while consumer advocates are wary.

In a nutshell, FDA has modified its 510(k) Refuse to Accept (RTA) policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s).

So far, so good.

FDAlogoIn order to enhance the consistency of acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, the agency says the guidance, including the checklists included in its appendix, clarify the necessary elements and contents of a complete 510(k) submission. The process is applicable to all devices reviewed through the 510(k) notification process and has been compiled into checklists for use by FDA review staff.

“It is critical to distinguish between the completeness of the regulatory submission, and the quality of the data provided and any studies conducted in support of the submission,” FDA says in the guidance. FDA’s assessment of the completeness of the 510(k) occurs during the acceptance review, while the assessment of the quality of the submitted information occurs during the substantive review. FDA will now base acceptance on the objective criteria outlined in the associated Acceptance Checklist, rather than the quality of the data.”

The medical device industry generally applauded the intention and basic guidance scope. However, some had concerns with specific criteria.

As Abbott states in its comment, “Although many of the elements are written in an objective manner to facilitate an administrative review, there are other elements of the checklists which, as written, are more subjective and begin to cross into a substantive review.”

AdvaMed, the medical device industry trade group, echoes that general spirit in its comment.

MITA, the medical imaging equipment manufacturing trade group, also echoed that sentiment in its comment.

Writing, it ” believes the MDUFA III agreement will improve FDA review of medical devices, ensuring that American patients have timely access to safe and effective medical technologies.” However, “to be effective, an improved process must rely on objective checklist criteria, clarify who is responsible for each task in the process, and encourage prompt and clear communication between the Agency and industry throughout the process.”

Finally, FDA encourages all submitters to provide an electronic copy (eCopy) in place of one of the two hard copies of the 510(k) submission. FDA has issued guidance to implement Section 745A(b) of the FD&C Act, added by Section 1136 of FDASIA, which provides statutory authority to require an eCopy for most submissions, including 510(k) submissions and amendments. With the implementation of this provision a valid eCopy will be required in order for a 510(k) to be processed and for the acceptance review to begin.

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

Simple Nutrition Facts for Complicated People

February 13, 2013 by Leave a Comment
Kim Egan

Kim Egan, Founder, Saltbox Consulting

Nutrition labels have been much in the news lately, presumably because we have once again won the Fattest Nation contest.  FDA and various nutrition researchers have all put out some thought-provoking information for us to ponder.

The Problem:

1.     People don’t understand nutrition labels.  FDA learned this by conducting extensive and expensive Internet-based research that showed that if you ask people to compare products made by different manufacturers to determine which is “healthier,” (whatever that means) they will not get it right.  In other words, they will get it wrong. I learned the same thing, much less expensively, by talking to the more strident members of my family at the dinner table.

2.     Pretty much nobody reads nutrition labeling on menus.  Among the reasons cited are “confusion” and the “priority of . . . hunger.”   Good luck fighting that one.  Hunger has been a priority since we descended from the trees or crawled out of the primordial soup or whatever your view of creation might be.

My Insightful Observations:

  • People who read food labels are slimmer than those who don’t.    So if we could fix problems one and two above we might not be the Fattest Nation anymore.
  • Women read nutrition labels and men don’t.   These results are possibly confounded by the fact that as far as I know, men don’t do much grocery shopping and if they do, they are simply executing the very specific instructions of the woman of the house, who may or may not be talking to the man at the store on a cellphone (“no, honey, the blue one with the red lettering, not the yellow lettering”).
  • If you allow food companies to decide what constitutes a serving size, you will end up with a label that says that one pickle can feed a family of four for three months.
  • Mexican-American and other Hispanic men read food labels more than other groups of men, e.g. WASPs. I assume this is because WASP men leave food procurement to the housekeeper or, if times are tough, to the wife.  Recall George H.W.  Bush’s astonishment at how much milk cost.

My Humble Solutions:

  • Get real about serving sizes.  I know Kraft says one box of macaroni and cheese serves four but everyone knows it serves ONE person.   Ask any college student.  A box of macaroni and cheese can serve four only if the four are super tall supermodels trying to go from 120 lbs to 112 lbs the night before New York Fashion Week.
  • Provide dietary information that is useful for consumers, not information that is helpful to manufacturers.Food Labeling
    • For example, FDA is considering adding an “added sugar” component to the label. The idea, I guess, is to help people get a grip on how processed a product may be.  Which is curious because most products that require a nutrition label are processed to begin with.  Hostess Twinkies (may they rest in peace) do not grow on Hostess Twinkie trees, so one can safely assume that everything in a Twinkie is “added.”
    • It would be more helpful to specify the kind of sugar in a product (glucose, fructose, sucrose, etc.), because some people actually need glucose while pretty much no one actually needs fructose unless it comes in the form of a piece of real fruit, and real fruit does not carry nutrition labels.  The Corn Refiner’s Association will no doubt disagree with me.
  • Revive Home Economics in public schools so that children learn what the information on nutrition labels means in the first place.
  • Call Mayor Bloomberg.  He seems to be getting this all pretty much right, in part because he is making food companies remove ingredients that are “harmful when used as directed.”  Trans fats are gone and salt content is down 25 percent.  All without the consumer noticing.

Kim Egan is the Founder of Saltbox Consulting, a firm that provides legal and compliance advice to entities regulated by FDA and USDA.  She can be reached at kim.egan@saltboxlaw.com and on Twitter at @saltboxlaw.

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Filed Under: Bloggers, FDA Regulated, Food, Kimberly Egan, Regulatory Tagged With: , , , ,

Study: FDA Enforcement Growing for Medical Device Companies

February 11, 2013 by 1 Comment
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Turns out that some paranoid people have a reason to, well, be paranoid.

Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

Maybe some in the medical device industry can be forgiven for thinking the FDA has come down harder on them in recent years.  A new study kind of backs their “paranoia,” too.

FDA efforts since 2009 to strengthen key policies has resulted in more medical device enforcement that will have a “long-lasting” effect on the industry, says an independent study from Greenleaf Health’s enforcement and compliance team. It was overseen by former FDA Associate Commissioner for Regulatory Affairs, Michael Chappell.

The Medical Device Enforcement Report focused on four specific area of medical device enforcement data: FDA inspections, 483s, warning letters and product recalls.

Medical Device Recalls

There is a general correlation between CDRH and FDA increasing recall numbers. In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011.

Here’s are some of the more telling stats:

  • Since 2005, CDRH inspections have accounted for 10 – 12% of all FDA inspections.
  • CDRH inspection numbers have increased at a rate consistent with FDA inspection numbers, the report sats. In 2005, CDRH inspected 2,304 facilities compared to 3,369 in 2011.
  • In 2008, CDRH issued 152 warning letters, compared to 200 in 2010.
  • In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011, according to data collected by Greenleaf.
  • Over the last five years, 483s issued to device manufacturers have accounted for 6% of all 483. The number of 483s issued by FDA – for all regulated products – has increased from less than 4,000 in 2008, to nearly 5,000 issued in 2010. The number of 483s issued for CDRH regulated products has remained steady over the 5-year period annually.

Greenleaf’s team suggests that these rising numbers can be attributed to a conscious FDA policy shift that includes more efficient review of warning letters, increased prosecution of misdemeanors, creation of the “Bad Ad” program, and the increased role and responsibility of FDA enforcement officials.

Here’s the $64,000 question: If you are paranoid that something bad is happening to you, and then you learn you may be right and not paranoid, is that a relief?

We’ll let those in the medical device industry speak for themselves on that one.

To purchase the full study, go to www.greenleafhealthllc.com

 

 

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Filed Under: Bloggers, FDA Regulated, Medical Devices, Michael Causey, Quality Management, Regulatory, Warning Letters/Recalls Tagged With: , , , , ,

New Year Doesn’t Change FDA ‘Old’ 483 Focus

February 6, 2013 by Leave a Comment
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Looks like the FDA missed the memo that it’s a new year. If recent 483s are any indicator, the agency hasn’t made any serious New Year’s resolutions about changing its enforcement focus.

In fact, we could turn to two ancient FDA beat reporters, William Shakespeare and WIlliam Faulkner, to perhaps best sum up the most effective way to predict the FDA’s enforcement strategy in 2013.

In The Tempest, Shakespeare tells us, “What’s past is prologue.”

Or you could go with Faulkner in Requiem for a Nun with its famous observation, “The past is never dead. It’s not even past.”

You could also skip the literary quotes and take a look at a recent crop of 483s yourself.

If you fancy yourself a speed reader, you might save time with a quick skim and quickly get the flavor of FDA’s top offenders, if you will. You’ll see the same terms and key words come up over and over in FDA 483s of late:

 

  • Procedures for receiving, reviewing and evaluating complaints not adequately established
  • Procedures for quality audits have not been adequately established
  • Procedures not established for quality audits.

warning640If you’ve got a bit more time, we think it’s worth it spending some of it taking a closer look at the agency’s most recent enforcement actions. In fact, an examination of a single month, October 2012, gives us many clues about where FDA inspectors are looking when they come calling.

In late October 2012, the agency hit D.E. Hokanson Inc.,  a vascular diagnostic product maker based in Bothell, WA, with observations the company had not adequately put procedures in place to review, receive and evaluate complaints by a formally designated unit.

Earlier that month, the FDA hit SRI Surgical, a medical device specifications developer in Maitland, FL, for failure to adequately establish CAPA procedures.

A day earlier, Malem Medical, a device manufacturer based in the UK with  offices in Maryland, was observed to have not adequately established procedures for quality audits — or adequately trained personnel.

On October 1 last year, the FDA hit Danmar Products, a device manufacturer in Detroit, also for not having established quality audit procedures — or adequately trained personnel.

It’s worth noting that each of these 483s came from a different FDA Inspector. In other words, this focus is wider than a single Inspector with a pet peeve.

The release of 483s lags a few months, so it is possible that the next crop of FDA 483s will show a radically different focus from FDA inspectors.

But don’t count on it. Neither William would.

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

Employees Must Wash Hands

January 23, 2013 by 1 Comment
Kim Egan

Kim Egan, Founder, Saltbox Consulting

On January 4 2013, FDA took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,000 years ago in to U.S. Government jargon.

It is interesting reading if you like that sort of thing. There is an entire section devoted to the hazards of sprouts and another to the taxonomic and agricultural definition of mushrooms. FDA takes no position on glass or metal fragments in soil, but the “hazards unique to cilantro” warrant mention. We are introduced to an excellent new phrase: “pre-consumer vegetative waste.”

There are some stupid new acronyms, like Raw Agricultural Commodity (RAC) and some blindingly obvious regulatory findings, such as: “The statutes we describe above, and previous interpretations of the concepts of RACs and processed food as set forth in the 1998 Joint EPA/FDA Policy Interpretation and the Antimicrobial Guidance, lead FDA to tentatively conclude that the basic purpose of farms is to produce RACs and that RACs are the essential products of farms.” (Translation: Farms grow produce and produce is what farms grow.)

farmThere are also a lot of exemptions, such as food grown for your own use and food that is not normally consumed raw. This means that FDA’s first ever effort to regulate farmers does not apply to asparagus, corn, eggplants, figs, lentils, peanuts, or potatoes, among many others. Figs? Why not figs? Fresh black mission figs on a cracker with brie are yum…

To spare you the agony of reading the whole thing, I have boiled the whole 547-page proposal down a few key points. If you are a farmer:

  • Wash your hands.
  • Clean your equipment.
  • Send sick employees home (this means infectious diseases as well as suppurating wounds).
  • Change your clothes if you just spent a bunch of time shoveling manure.
  • Don’t put portable toilets smack in the middle of your irrigation source.
  • Don’t dump raw sewage on your fields.
  • Don’t let dead wildlife decompose in your fields.
  • Don’t harvest rotten apples.
  • Don’t bother with Purell; it doesn’t work on actual clods of dirt or manure.

Were I Queen, I would add:

  • Wash your produce before you eat it.
  • Know where your produce comes from, and don’t eat it if it came from a sewer or a nuclear power plant.
  • Follow the “Diplomats Rule” when traveling, i.e.,:
    • things with rinds or husks (oranges, nuts) are usually safe
    • things filled with water (lettuce, tomatoes and cucumbers) less so,
    • eventually you will acclimate, and
    • alcohol cures all.

But this is in fact a serious topic and I think the Food Safety Modernization Act misses the point. FDA really can’t do this by itself and the produce farmer is not the problem. If we want to improve the safety of our food supply, we need to:

  • Figure out a way to keep pharmaceuticals out of the water supply. If they aren’t in the water supply to begin with, they won’t end up in our lettuce and cucumbers.
  • Figure out a way to reduce our over-reliance on antibiotics. We would be less susceptible to food-borne illnesses in the first place if we didn’t routinely carpet bomb the flora in our bodies that keeps us healthy.
  • Figure out a way to prevent surface water run-off. I propose building codes that require green roofs for all new commercial structures over a certain size, and that require green verges on all new roads, etc.
  • Apply existing tort law to food producers who negligently or intentionally put a dangerous food product (raw or otherwise) into inter-state commerce. For biotech crops and hybrid seeds, this could include design defect and manufacturing defect claims, which can carry substantial financial penalties.
  • Take serious steps to increase agricultural biodiversity, which would include ending or seriously reducing subsidies for corn, wheat and sugar, and encouraging effective crop rotation.
  • Solve the problem of migrant farm labor. We depend on undocumented workers to harvest our crops because it turns out that picking tomatoes it not really “unskilled labor,” as the recent example of Alabama shows.

In the meantime, let’s keep things in perspective. A little dirt never hurt anyone.

Kim Egan is the Founder of Saltbox Consulting, a firm that provides legal and compliance advice to entities regulated by FDA and USDA.  She can be reached at kim.egan@saltboxlaw.com and on Twitter at @saltboxlaw.

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Filed Under: Bloggers, FDA Regulated, Food, Kimberly Egan, Regulatory, Risk Management Tagged With: , , , , , ,

Utility Industry Grapples with Larger NERC Enforcement Penalties

January 22, 2013 by Leave a Comment
Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

As we approach the sixth year of mandatory compliance with the NERC Standards, we can see that NERC and the Regions are becoming more experienced dealing with the audit findings and penalties.  As shown in the last two releases of NERC enforcement actions, the non-compliance fines are larger and larger.  We have seen some penalties well over $500,000 (see $725,000 and $950,000 fines, too.)

Some registered entities are leading by example, with strong compliance programs and engagement with industry.  Registered entities are sharing experiences with each other in forums and workshops. They’re talking about their experience with Electric Reliability compliance software, and hiring consultants for independent reviews.  A few companies have even implemented the needed internal corrective action programs (CAPA) that benefit their Find, Fix, Track and Report (FFT) initiatives.

That’s the good news!

The relative bad news is that registered entities are still out there trying to doing the absolute minimum for NERC compliance.  There are reasons for this including a tough economy and over-worked resources.  Registered Entities that have tried to maintain compliance with limited resources and managing through many spreadsheets, weak document control, and lack of proper compliance participation in the industry.  We are still seeing common mistakes out there that can be easily corrected.  As the top Electric Reliability software provider, we see best practices that can anticipate or correct these problems.  Our customers are sharing their success with other companies.  Some of those successes include:

Registered Entities need to take a look at best practices, talk to their industry counterparts and evaluate their programs. They also need to look at strong compliance software tools, remove burdensome internal processes, and build a reliability culture that will be engaged, proactive and identify issues before they become signification violations.

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Filed Under: Bloggers, Electric Reliability, Featured, Regulatory, Risk Management, Trey Kirkpatrick Tagged With: , , , ,

FDA to Medical Device Submitters Using WebTrader: Remove Your Files Now

January 17, 2013 by Leave a Comment
Tamar June, VP, Strategic Marketing, Product Manager - eMDR

Tamar June, VP, Strategic Marketing, Product Manager – eMDR

A January 11, 2013 email sent by Michael Fauntleroy, Program Manager, FDA ESG, is warning those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future. WebTrader is a supposed to be a low-volume submission tool, however, some companies have apparently been using the system as a file server or archival system.

FDA states that the misuse of the system has resulted in significantly lower performance for all other account holders. They suggest removing the submission records and storing it either locally or on a company-wide network. The email also listed the number of “offending” accounts:

1 account has more than 3000 documents
9 accounts have more than 2000 documents
34 accounts have more than 1000 documents
96 accounts have more than 500 documents
763 accounts have more than 100 documents
2833 accounts have more than 20 documents

(Each submission transmission has 3 – 4 documents associated with it. e.g. 20 documents in an Inbox  translates to 5 -6 submissions).

According to FDA, “…ESG’s WebTrader functionality is provided to the industry by FDA as a low cost alternative to send submissions to FDA. The WebTrader Inbox provides the users a view of submissions sent to FDA and receipts and Acknowledgements received from FDA. This inbox should not be used as a storage place for your Receipts and Acknowledgements – once you receive Receipts and Acknowledgements for your submissions you should;

  • Download Receipts and Acknowledgements and save them to your local machine
  • Delete records from your WebTrader Inbox

Following these steps will ensure faster display of the Inbox for you, other ESG users and increase overall performance of the system.”

The email also states “The account owners that have more than 2,000 documents in their WebTrader Inboxes will be receiving an email with a zip file of their messages.  We will delete these documents from your Web Trader Inbox at the FDA immediately. This policy is being re-implemented on a permanent basis.”

In the closing paragraph of the email, written in red ink, the FDA sternly warns: “On February 1, 2013 we will start deleting documents in Web Trader account Inboxes without notice.  Any Web Trader Inbox with more than 20 documents in it will be cleaned starting February 1, 2013. Once the Inbox is cleared of documents (Receipts and Acknowledgements) they cannot be retrieved so WE STRONGLY ADVISE YOU TO DOWNLOAD RECEIPTS AND ACKNOWLEDGEMENTS FROM YOUR INBOX after each transmission.”

Clearly, those who have hundreds or thousands of documents should probably consider upgrading to another type of eMDR submission system.

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Filed Under: eMDR Updates, FDA Regulated, Medical Devices, Regulatory, Tamar June Tagged With: , , , , ,

Drug Labels: Free Speech Yes, Dangerous Speech No

December 19, 2012 by Leave a Comment
Patrick Stone

Patrick Stone, President, TradeStoneQA

The U.S. Court of Appeals for the Second Circuit just overturned the conviction of a drug sales representative promoting off label use for a narcolepsy drug that included fibromyalgia, restless leg syndrome and insomnia (use for drug not approved by FDA). The Dec 3 court decision determined that this falls within the realm of free speech and should be protected. So, they overturned the sales reps 2008 conviction of introducing a misbranded drug into the market.

So is it really just about free speech?

Many off label uses for drugs may be similar in nature to the varying disease states. But the indications above could not be more far apart. Narcolepsy is a debilitating nervous system disease where you fall asleep uncontrollably. Insomnia is a state where you can not fall asleep at all.

Free speech should not harm your fellow citizens. That’s just dangerous speech. I don’t think the Constitution intended to encourage that.

Patients may be harmed by off label use of a drug that has not been clinically proven for that specific disease state. The drug companies are making hefty profits to cover more clinical trials to prove more uses for their medical health products. Off label use does may not always capture SAEs related to off label use. The new SAE’s encountered may not be included for addition to product labeling nor does it prove the off label treatment is effective for the “new use”.

Free speech is not free when the consumer purchases a prescription and is then injured by that drug. Far from free, the patient pays a big cost.

It is very difficult for the average patient to prove a specific drug caused them harm unless they are under a clinical trial where blood and urine samples are drawn regularly to keep track of their health.

I am certainly not against new safe and effective treatments, I am against snake oil salesmen touting panacea “cure all” drugs when in reality no such thing exists.

The False Claims Act for off label drug promotion is a very specific statute. It’s there to keep our medical health product manufacturers and innovators honest.

But false claims aren’t the only law being broken by some offenders. These other offenses include: Physician payout for prescriptions, suppressing risk of the treatment, fictitious clinical trials and price fixing.

There are many more schemes involved and here is a link alerting us to many recent false claims payouts that may break the half a trillion mark.

The FDA will appeal the recent court decision, and this may go to the U.S. Supreme Court for final disposition. But the question remains, will we go back to the snake oil salesman of yesteryear or move forward with transparent, safe and effective health care treatments?

Let’s remember why the FDA was formed over a hundred years ago. It’s about protecting the public health. Not about protecting dangerous speech.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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Filed Under: Bloggers, FDA Regulated, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , ,

It’s Time for FDA, States to Step Forward for Public Health

December 5, 2012 by Leave a Comment

Patrick Stone, President, TradeStone QA

It’s clear that the FDA should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?

The recent news is troubling.

Example: According to state and federal records, it took FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for compliance branch local district directors to decide on a firm’s regulatory outcome. The FDA mandates strict 483 fifteen day response letter times and should also be held to a 60 or 90 day turnaround.

As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a 6 month follow up that should be conducted.

But if regulators give the regulated industry time to make more  lethal products who is to blame? Usually FDA gets local state authorities involved for immediate detention and embargo of harmful products. Each state has unique authority over products made within it’s borders if they are held for interstate trade. The New England region was also involved with the FDA inspections. The state could have stopped many products from interstate trade before the situation escalated.

PharmaceuticalsThe FDA’s initial inspection on this product began in September 2004 and ended on January 19, 2005. In the Dallas district an Investigator would be reprimanded for taking five months on an inspection. It does not take that long to conduct a compound pharmacy inspection or to collect product samples. It usually takes two or maybe three weeks for this type of inspection. Each district has time limits that can be spent on any one assignment. There seems to be a pattern of errors here that could have prevented lives from being lost with much time wasted.

Going forward FDA must adhere to internal timelines for all inspections and final regulatory compliance determinations. State Pharmacy Boards should allow FDA inspections of firms that compound sterile drug products for conformance with U.S. Pharmacopeia (USP) chapter <797> “Pharmaceutical Compounding – Sterile Preparations,” or cGMP’s. Compound pharmacies should partner with FDA in order to insure safe market distribution of approved drugs.

This should not be a regulatory turf war – it’s a matter of public safety. The state should be brought in early and if necessary take immediate detention and hold actions.  This is a tragic learning experience that should be reviewed with rapid corrective action implementation.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

 

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Filed Under: Bloggers, FDA Regulated, Patrick Stone, Pharma/Biotech, Quality Management, Regulatory Tagged With: , , , , ,

The Only Vote That Counts: FDA 483 Round-Up

November 6, 2012 by Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Pollsters, prognosticators and pundits love to obsess over the polls before Election Day. Their self-appointed task is sifting for nuggets that will tell us who will win before anyone has actually cast a ballot. But as wide political sages like to say, “The only poll that matters is the one on the day people actually vote.”

Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training.

A letter issued after a month-long inspection that ended in May 2012, cited Cardiva Medical in Alameda, California for failing to adequately train its workers. Its Cardiva Catalyst is “designed to increase the comfort of the manual compression process and facilitate the body’s healing process,” according to the company’s website. It also allegedly failed to identify future training needs for its personnel, the 483 said..

voteDevice manufactuer Coviden in Chicago was chastised after an inspection earlier in the year for CAPA shortcomings lacking “quality data sources that indicate the occurrence of high risk non-conformities.” The firm was also found wanting for failure to have a CAPA in place to “ensure that failure investigations are comprehensive.” Further, the FDA says it found a lack of a CAPA to “correct and prevent the issue of incomplete device history records.”  Coviden manufactuers a number of products, including respiratory monitors and endomechanical products.

Other CAPA-related problems were found at Denver-based Sandhill Scientific. There, the FDA alleges the company lacked adequate an adequate CAPA program to address nonconformities and root causes. The company manufactures monitors aiding in acid reflux detection and a high resolution manometry system.

Arrow International in Parsippany, New Jersey, a Class II manufacturer of catheters,  was hit with a 483 because “a validated process was not reviewed and evaluated when changes or process derivations occurred.”

We’ll keep tallying FDA’s real “votes” and an eye on real trends coming from the agency.

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