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complaint definition fda

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When one of your products triggers a customer complaint, you respond pronto. You dot the i’s and cross the t’s. You think you’ve made all the right moves, but chances are …

… you haven’t.

Worse, you may have inadvertently exposed your company to sanctions. Penalty letters … design changes … new UDI-DI … correction/removal … new 510(k) … all are possible.

Regardless of where you base your operation — the U.S., the EU or Canada — the problems are the same. Your company quietly changes even one long-standing practice and presto, you find yourself facing a punishing sanction.

You need a system. You need a plan. You need:

Medical Device Complaint Management Building a Robust System to Meet Global Requirements

Mark your calendar for Boston in February, when FDAnews and Ombu Enterprises host an all-new two-day workshop that’ll transform your device company into a well-oiled complaint management machine.

You start with a hypothetical complaint, then trace it through the regulatory system. First come lectures, then interactive exercises — 11 of them over two days. You find yourself out of your chair and engaging with devicemakers like yourself — from the E.U., Canada and all across the U.S. — confronting and solving shared problems.

At the conclusion of each small-group exercise, you take a test. But not to worry — you can’t fail. Answers will be provided, plus proven solutions to take home and apply in your operation. We know of no other workshop providing such fine-grained level of interactivity, not to mention solutions you can put into effect — at once.

Your mentor is Dan O’Leary, a 30-year veteran of device quality compliance and five-star presenter. Mr. O’Leary is a master at working with devicemakers large and small to apply proven methods that build end-to-end complaint management systems.

Here’s just a taste of topics you’ll cover:

The role of Unique Device Identification (UDI) in complaints and adverse event reporting Regulatory reporting requirements in three major markets: U.S., EU, Canada Understanding why the complaint source (Facebook, Twitter, email, phone call) is not your chief concern — it’s how you handle the communication Proper use of corrective action in complaint management, including statistical analysis Developing a complaint classification system that links to the risk management file Analysis methods to determine impact of design changes on regulatory requirements Planning field actions and making regulatory reports And much more Click here for the full two-day program schedule.

In your fast-changing world, facing multiple regulatory bodies with complex and ever-changing rules, an effective complaint management program is a must. Don’t let an inefficient, outmoded complaint management system bring you down – not when help is at hand. Sign up now.

Course Description

This workshop helps you understand the regulatory system by starting with a complaint and tracing it through the various regulations, including interactions with regulatory agencies.  Complaints are an unrecognized problem in a company’s marketed product. Depending on the nature of the complaint, it could lead to corrective action, design changes, new UDI-DI, correction & removal, or even a new 510(k).  Using past experience and interactive exercises, this workshop teaches attendees how to deal with complaints and their implications throughout the entire regulatory structure in the US, EU, and Canada.

When one of your medical devices triggers a complaint, you respond immediately. You dot each i and cross each t. You think you’ve taken every prescribed step.

But complaint management is ever changing.  Recently there’s been a big focus on customer complaints through a company’s social medium channels.  Should your focus be on the complaint itself or the channel it was submitted through?

And despite all your hard work and focus on managing complaints, you and your colleagues still receive a Warning Letter. What’s going wrong?

What you may not realize is that FDA scrutiny can probe every aspect of your operation — customer service, field servicing, sales, device reporting, CA&PA, design change, corrections and removals, and more.

You need a system wide solution — one that turns your entire operation into a well-oiled complaint-handling machine. If you aren’t sure how to pull it off … FDAnews has created a one-of-a-kind workshop to help.

Using a combination of lectures and interactive exercises that will get you out of your chair and, working in small groups, this workshop will guide you through how to assure you’re focusing on ALL the areas that the FDA looks to hunt and peek within.

Dan O’Leary — a 30-year veteran of device quality compliance — is a master at working with companies large and small to apply proven methods to build end-to-end complaint management systems.

Through a combination of presentations and small group exercises Dan leads attendees through their toughest problems. At the conclusion of each presentation and exercise a “test” will take place, answers will be provided and attendees will have proven solutions they can take back to their operations. No other workshop provides this level of interactivity and take-home solutions.

Register Today.

Course Binder Materials: Full slides from the PowerPoint presentations A copy of each interactive exercise worksheet as well as answer keys An annotated version of MDR sections regulation based on recent Warning Letters An Excel worksheet that helps analyze the FDA regulations. It has a series of questions that start with a complaint and follow the reporting and record keeping decisions to help understand the integrated requirements spread across different parts of the regulations. Reference documents: FDA guidance on Medical Device Reporting FDA draft guidance on Medical Device Reporting Comparison of MDR Rule Changes FDA guidance on Enhancements and Recalls Comparison Part 7 and Part 806 definitions FDA guidance document on 510(k) changes MEDDEV document on the Vigilance System Health Canada document on Medical Device Problem Reporting

your expert speaker

Dan O'Leary,

President at Ombu Enterprises, LLC


"[Dan is an] Excellent speaker. Great experience and examples. Interactive discussions in particularly were very helpful.” — Brian Ray, Senior Manager Risk Management, Welch Allyn

"Dan is an excellent speaker who folds a lot of knowledge and experience.” — Joaquin Bautista, Quality Specialist, Colgate-Palmolive Co.


Who will benefit?

Quality Managers Regulatory Affairs Managers Engineering Managers Quality Engineers Design Engineers Project Managers involved in design and development Specialists assigned to complaints, corrective actions, or medical device reporting Recall coordinators Medical staff evaluating risk, safety or effectiveness General/corporate counsel

This conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification.

Team Discounts

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

    Agenda  |  Venue  |  Speaker  |  Register

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA. Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578


What Does the FDA's Definition of 'Gluten-Free' Mean for You? Nine Facts You Need To Know About Gluten-Free Labeling By Jane Anderson Updated January 01, 2015 Share Pin Email Print What is gluten-free? According to the FDA, it's products with less than 20 parts per million of gluten. © Jane Anderson More in Celiac Disease Gluten-Free Diet Recipes Coping Personal Care Products Side Effects Vegetarian and Vegan Kitchen Basics Symptoms Tests and Diagnosis How to Cope Gluten-Free Food Shopping Gluten-Free Snacks Gluten-Free Grains Gluten-Free Alcohol Dining Out and Socializing Gluten Sensitivity Cooking Tips Gluten-Free Beverages Related Conditions Medical Issues Glossary View All

What does the FDA's definition of gluten-free mean for you?

The U.S. Food and Drug Administration has formally defined the term "gluten-free" as less than 20 parts per million (ppm) of gluten. But what does this mean for your day-in, day-out grocery shopping? Here are your questions answered.

Question: What are the basics of this new gluten-free rule from the FDA?

Answer: The FDA gluten-free label rules mean food companies need to follow certain specific guidelines in order to label something "gluten-free."

According to these guidelines, something with a "gluten-free" designation on the packaging:

Can't contain the gluten grains wheat, barley and rye, or crossbreeds of these grains, such as spelt or Einkorn wheat (note that there's an exception to this rule, which I detail below) Must contain less than 20 parts per million of gluten

Here's the exception to the first rule: a product can contain ingredients derived from the gluten grains wheat, barley and rye, as long as those ingredients have been processed to remove the gluten , and as long as the resulting final product contains less than 20 parts per million of gluten .

Examples of ingredients derived from gluten grains but processed to remove gluten can include: wheat germ oil, wheat or barley grass , and barley-based enzymes.

Question: Does this rule mean that products labeled "gluten-free" will contain zero gluten?

Answer: No, not at all. Under the FDA's rules, products carrying a "gluten-free" designation can have up to 20 parts per million of gluten in them.

According to the FDA, "most" people with celiac disease can handle a small amount of gluten in their food each day (the studies haven't been done to see whether that much gluten harms people with non-celiac gluten sensitivity ).

However, plenty of people react to levels of gluten below 20 ppm. So if you get glutened after trying a new "gluten-free"-labeled product, don't assume you're reacting to something other than gluten — it's perfectly possible that you're reacting to the trace gluten in that product, even if it meets the FDA's legal definition of "gluten-free."

Here's some more information on this:

Foods Labeled 'Gluten-Free' May Still Contain Some Gluten I'm eating gluten-free, but I still have symptoms. Why am I getting sick? Why Gluten PPM Numbers Matter How Much Trace Gluten Is In Your Gluten-Free Food? Table Listing Different PPM Testing Limits for Manufacturers

Question: Are companies required to label something gluten-free if it doesn't contain any gluten?

Answer: Nope. The regulations are strictly voluntary. However, many companies are well aware of the growing popularity of the gluten-free diet, and want to serve the gluten-free market.

Question: Do the regulations now require companies to disclose gluten in products?

Answer: No again — the rules governing disclosure of allergens haven't changed. See more on this here: Do food labeling laws require manufacturers to disclose gluten ingredients?

Question: How long do manufacturers have to comply with the new rules?

Answer: They have until August 1, 2014. However, the FDA says that 95% of all gluten-free-labeled products on store shelves right now actually meet the requirements just fine.

Question: Do the FDA rules require manufacturers to test their products for trace gluten if they're labeling those products "gluten-free"?

Answer: Unfortunately, no, they don't. If it's important to you that you buy only food products that are tested periodically for trace gluten, then you'll have to contact individual manufacturers to see if they test their products.

Question: I found a barley kernel in my lentils. Do the new FDA regulations address this kind of gluten cross-contamination issue?

Answer: Yes. The FDA is well aware of problems that stem from shared harvesting and storage facilities for various commodities (see more on this here: Wheat Harvest Time Shows How Cross-Contamination Occurs ). Under the FDA rules, food products — even single-ingredient products like sorghum flour or your lentils — cannot sport a "gluten-free" label unless they are tested to contain less than 20 ppm of gluten.

I doubt your lentils would qualify.

Question: What about "gluten-removed" beer made from barley — can that carry a gluten-free label?

Answer: As of right now, no, it can't. There are two federal agencies that govern beer: the FDA and the Alcohol and Tobacco Tax and Trade Bureau. The alcohol bureau told brewers in 2012 that it wouldn't allow a gluten-free label for beer made from barley because the tests to detect gluten in those brews may not be reliable. The FDA, meanwhile, is studying the issue and intends to propose a new rule detailing its approach to making sure these types of products meet gluten-free labeling standards.

Learn more on this:

Labeling Rules for Gluten Grain-Based Alcoholic Beverages Gluten-Removed Beer: Is It Safe on the Gluten-Free Diet?

Question: So will these new FDA rules change how we shop for gluten-free food ?

Answer: Quite honestly, probably not that much. The FDA notes that the rules can give us confidence that the food products we buy meet the agency's gluten-free standards ... but the vast majority of products on the market today (19 out of every 20) already do meet those standards.

If you can eat most of the gluten-free-labeled products out there now without getting sick, you should be able to continue that (and it's possible you'll get glutened even less often than before). If, however, you're sensitive to trace gluten below the 20ppm standard, you'll still need to carefully shop for products you know meet a more stringent standard, such as those that are certified gluten-free .

Show Full Article Up Next Up Next Article

I'm Gluten-Free. Should I Eat Only Certified Gluten-Free Products? Up Next Article

What Does Gluten-Free Certification Mean for Consumers? Up Next Article

Is Rice Dream REALLY Gluten-Free? Up Next Article

Is 'Gluten-Removed' Beer Really Okay on the Gluten-Free Diet?