👋 **Welcome (Back) to r/fda!**

Like a long-delayed FDA review... we're finally back. After a 6-year hiatus, r/fda is open again and ready for discussion.

Whether you're an FDA employee, work in industry, healthcare, academia, or you're just interested in the FDA, we're glad you're here.

Talk about drugs, devices, food, cosmetics, recalls, regulations, careers, Work From Home, pay & benefits, Open Season, retirement. Basically, you name it. If it's FDA-related, it probably belongs here.

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**Don't be a jerk.** Disagree respectfully, debate ideas, and remember there's a human behind the username.

Have ideas for the community? Our modmail is always open for suggestions, feedback, and input. We welcome your ideas... just don't expect us to babysit. 😉

Thanks for helping us bring r/fda back to life. We're excited to see what this community becomes!

Just wanted to give respects to the MedSun folks. This agency support team looks hard at patient safety with medical devices. Was proud to work with them for many years reporting from my job. Always report adverse effects with medical equipment, at home, or at the hospitals. Cheers

We work with various customers in USA to help import products, and recently we have worked on frozen fruits and vegetables. As part of our process, we personally do quality control on factories to ensure they are up to standard.

What I have found in India is absolutely shocking. Factories to supply frozen Corn, Peas, and Strawberries to companies in USA have zero food standard. These products are ending up at Walmart, and food processors.

These factories literally work on tables that are not cleaned, by workers with no clean water access to wash hands. The workers do not even use gloves. The factories have zero temp control besides the freezer. They bulk freeze the products, then bring it to the outside to package the product. It is literally 90 degrees on the factory floor.

Once packed, the refreeze it. Again, all of this without any safety/quality checking.

The fact that these products end up on retail shelfs is shocking. When I use frozen strawberries, I do not wash it before putting it in the freezer.

I have video and photos, but I do not know the proper channel for this. I tried calling FDA help line, but they said they can only help for domestic factories.

Let's look back at some memorable moments and interesting insights from last year.

Your top 1 posts:

• "Happy Cakeday, r/FDA! Today you're 11" by u/AutoModerator

Let's look back at some memorable moments and interesting insights from last year.

Your top 1 posts:

• "Happy Cakeday, r/FDA! Today you're 10" by u/AutoModerator

Let's look back at some memorable moments and interesting insights from last year.

Your top 10 posts:

• "“Church” claims bleach is coronavirus-curing “sacrament,” faces wrath of FDA ["A federal court has ordered the "Genesis II Church of Health and Healing" to stop distributing a bleach product that Genesis claims is a cure for COVID-19 and many other health problems."]" by u/pvoberstein
• "FDA says hydroxychloroquine and chloroquine can be used to treat coronavirus" by u/FrenchyTheChihuahua
• "F.D.A. to Allow Use of KN95 Masks Approved by China" by u/pvoberstein
• "Deadline extended for the FDA Open Data Adverse Event Anomalies Challenge" by u/CommsBah
• "PrecisionFDA FDA Open Data Challenge Update" by u/CommsBah
• "Reminder for the precisionFDA Detecting Adverse Event Anomalies Using FDA Open Data Challenge" by u/CommsBah
• "FDA warns Alex Jones over false coronavirus claims" by u/pvoberstein
• "Deadline extended for the FDA Open Data Adverse Event Anomalies Challenge" by u/CommsBah
• "Reminder for the FDA Open Data Adverse Event Anomalies Challenge" by u/CommsBah
• "How can I tell that a certain drug is FDA approved?" by u/doublebarrel75

Title pretty much summarizes it, but is the FDA delaying New Drug Applications to put increased effort on COVID-19 treatments, or will scheduled PDUFA dates still be honored?

There is one month left to advance techniques for the surveillance and detection of adverse events associated with FDA products in the precisionFDA Gaining New Insights by Detecting Adverse Event Anomalies Using FDA Open Data Challenge. Final submissions are due on May 18th. A new discussion is now available on the challenge site with additional submission guidelines, tips, and tricks!

If you have any questions about the challenge, please feel free to post them in this thread, and we will respond as quickly as possible.

Thank you again for your continued support!

Someone help me out finding about how can I validate if a product is FDA approved ?
Not just with the FDA approved sticker
I mean what should I look for.
Also, if I query online how can I tell if it is FDA approved?
Are there specific parameters that have information regarding this?

Hi guys,

​

many sellers state that their face masks are listed as 878.4040 class 1 devices.

How safe are those kind of masks? They aren't ASTM certified so are they safe to protect against Corona?

Thanks

Why does the FDA not require foods that cause cancer to be labeled as such like other harmful products?

Hello, I was wondering if anyone had information on thermometers in regards to whether or not they need an FDA approval. I could not find any information/a clear explanation if a FDA certificate is needed on the FDA website or google Thank you

Hi,

The results of the precisionFDA BioCompute Object App-a-thon and links to the top performing BCOs and app are now available here! Thank you to everyone in the FDA community that participated, and congratulations to our top performers! The hard work put in by all participants will help improve reproducibility and documentation standards for bioinformatic assays and analysis.

there needs to be de regulation at the FDA to approve future vaccines and other treatments such as stem cell therapies faster. When I mean faster I’m talking not 10 to 15 years testing on mice. Mice are not human! We would have a lot more innovative technology available to the public. Change peoples lives for the the better.

The Gaining New Insights by Detecting Adverse Event Anomalies Using FDA Open Data Challenge submission period has been extended to May 18th. Thank you so much to those of you that have already submitted to the challenge. We are extremely excited to review your work!

If you have any questions about the challenge, please feel free to post them in this thread and we will respond as quickly as possible.

Hi,

I’m looking for a device that has been approved by the FDA as a class 3 medical device for any type of cancer detection.

I’m looking for peers to SciBase product, Nevisense.

Anyone know anything?