Dietary Supplement Warning Letter Immersion Center - Letters Categorized by Type

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Updated July 22, 2021

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Warning Letters Related to Food, Beverages, and Dietary Supplements - FDA.gov

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If you're tracking FDA Warning Letters issued to dietary supplement companies, follow the link below:

NPI Warning Letter Immersion Center:

"This Warning Letter Immersion Center is a place to find the latest information on warning letters sent to dietary supplement and related companies. Included is a table of all the known warning letters to date, including a link to the full text of each letter on FDA website."

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AMA Declares Obesity Is A Disease

Updated November 17, 2020

Sadly, links broke in the original post.

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Obesity Is Now A Disease, American Medical Association Decides - Medical News Today

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90 Million Americans Wake Up to New Disease as Obesity Reclassified:

"Obesity has been official declared a disease by the American Medical Association after passing a vote this Tuesday. As such, this effectively means that upwards of 78 million adults and 12 million children across the US have a dangerous medical condition that demands treatment."

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FDA Inspection Classification Database Search - Free

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FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

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FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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FDA Expected To Rule On Mercury Dental Amalgams

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I'm so glad that I don't have mercury fillings in my mouth anymore. Unfortunately, I've got a mouthful of crowns, and precious little left of my natural teeth. I ran across this press release, and thought you'd be happy to know that the FDA is expected to rule on mercury-containing dental amalgams, "Resolution to Study Phase Out of Mercury Tooth Dental Fillings Receives 16% of Vote at Danaher Shareholder Meeting." The press release states, "Some-time in late July, the Food and Drug Administration is expected to rule on the use of mercury amalgam. The Consumers for Dental Choice won a 10-year battle with the FDA to comply with the law and set a date to classify mercury amalgam." 

Related Posts: Caution - Teeth Whiteners Can Reduce Enamel Strength Mercury-Containing Dental Fillings - Health and Environmental Concerns 

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Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips

It's better to know what's needed upfront, than to get hung up at the last moment in the 510k process. "FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes," reports Nicolaas Besseling in, "Five Tips for Quick FDA 510k Clearance for Medical Devices." In a nutshell . . .

1. Find out if the FDA regulates the device
2. Make sure the classification of the device is correct
3. Determine who will be the owner of the 510(k), and who will be the official correspondent
4. Use (a) predicate device(s) that is close to the new device
5. Pay close attention to the formatting of the submission

Following the 5 tips above won't necessarily guarantee success because there are many nuances and traps to avoid. If you're not expert in 510k filings, you might want to consider partnering with an industry consultant.

Related Posts:
Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)
FDA 510(k) Free Tips And Pearls Of Wisdom
Medical Devices - A murky 510(k) world?!

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Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

1. Introduction
2. Regulatory Definition of Medical Devices
3. Risk-Based Device Classification
4. Safety and Effectiveness Requirements
5. Food and Drug Administration Programs/Regulatory Pathways
6. Quality Systems Regulation (QSR)
7. Regulation of Drug-Device Combinations (Combination Products)
8. Guidance Documents Available to the Device Industry
9. Conclusions

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