United Health Products Inc (QB) (UEEC)

lol Trust you’re making me get nervous. You’re getting very paranoid lol TrustTheman trust me this will get done eventually way too much time. Effort and money went into this.

Notice every negative post on the FDA is instantly being deleted. Tells you that the low life, bought off turds over there are watching this board.

I honestly don’t know what to say we are at a stand still at the moment again unless Brian gets this done he worked for the past several years in this capacity for a stock that’s worth five cents that he can’t even sell so that being said, I have to believe as they say in the movies, as Rocky said, I didn’t hear a bell This isn’t over far from it in my opinion at this point, I really don’t believe that these major pharmas are blocking us I don’t believe Johnson and Johnson is terrified of us and is paying the Fda let’s face it guys if that was really the case Johnson Johnson could buy us up in the blink of an eye at a price that would probably make all of us pretty happy and they can have the superior product

The FDA can't possibly approve fiction.

Just to add, it has no association to reality either. It sounds more like suckers are needed to dump shares on.

Just to add, finalizing a sponsor between sponsor company and UEEC has nothing to do with the FDA. This isn't the FDA holding up again.

Keep in mind, the track record is that progress happens and it takes weeks for the PR to be generated and released (not sure why it takes so long). For all we know, there could be a sponsor already and we just haven't heard about it yet.

I don’t know Trust.. very quiet these days.. that doesn’t entirely mean that there isn’t anything going on behind the scenes.. but deals are made and they’re made slowly as a result of due diligence and legal and a lot of hands in the soup.. it’s not 1 chef that does it all I’m sure.. especially on the other side assuming there is “the other side” and I’m sure the “other side” isn’t a start up but rather a company that is acknowledged by the FDA… patience friends

He wouldn’t had a sponsor by now if he could’ve gotten one. Either Thom is a moron or the FDA is corrupt and just makes up new shit as they go along or a combination of both.

Not going to deny or question that this is rocket ready to go providing we soon get what we are waiting on

Better jump on before this one pops!

There may be life here in this penny stock if the company has a sponsor, no sponsor no life.

🙏🏼🙏🏼🙏🏼 my friend

There appears to be some life left in UEEC based upon the buying and pps increase this week.

I hope it’s moving my friend in my opinion way too slow for everything but we shall see

Per the last pr....In addition to its agreement with this clinical study arrangement, the FDA has approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP’s protocols, procedures and personnel that was recommended by the FDA. The goal of this audit, which will be conducted in the coming months, is to assess and confirm the company’s ability to conduct its own clinical trial in accordance with all applicable FDA regulations.

FDA approved the audit of UHP and really had pushed for the assessment of the UHP internal management practices. About as far as you can go without outright refusal of the PMA and IDE. Months stated will hopefully be sooner! At least FDA sees and is confirming a pathway for approval!! Stay the course a pharmaceutical has likely been selected AND where the company will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application.

💯 my friend ..: progress would be wonderful

Anyone hearing anything? I would have thought by now we would have had some news or update. *headshake*

Anyone have anything that they would like to say?

Nice close.. got some volume end of day… let’s keep the faith

As I said way back when shit or get off the pot

I’m at E*Trade and you can’t market order this at E*Trade… these yo-yo’s are just hitting the bid and selling.. or it’s a market maker pushing it down to cover the short by making it go further..

I’m at E*Trade and you can’t market order this at E*Trade… these yo-yo’s are just hitting the bid and selling.. or it’s a market maker pushing it down to cover the short by making it go further..

Never understood people who sell at market price if you’re gonna sell put a limit on it.

Why are there clinical trial phases for Class III medical devices?

Phase I clinical trials typically involve a small number of healthy volunteers. They are designed to assess the device’s safety and potential adverse effects.

Phase II clinical trials involve a more significant number of subjects. They are designed to evaluate the device’s effectiveness and safety in patients with the target condition.

Phase III clinical trials involve a more significant number of subjects. They are designed to confirm the device’s safety and effectiveness in a larger patient population. The results of the clinical trials are then submitted to the FDA for review and approval.
https://qualitysmartsolutions.com/blog/class-3-medical-devices-regulatory-requirements-unlocked/
How to Navigate Regulatory Requirements for Class III Medical Devices
February 7, 2023
Home » Blog » How to Navigate Regulatory Requirements for Class III Medical Devices

Tags: Class 3 medical devices FDA Medical Devices Health Canada Medical Devices medical devices
Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Understand the Regulatory Requirements of Class 3 Medical Devices. Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations. Step-by-Step Guide for Regulatory Compliance Process. A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below: 1. Understand the local and international standards and regulations that apply to your product. 2. Perform risk assessments, identify hazards, and assess safety risks. 3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications. 4. Prepare preclinical tests related to the identified safety risks of the medical device. 5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary. 6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws. 7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device. Strategies to Reduce Cost and Time in Compliance Testing. There are strategies to reduce the cost and time associated with compliance testing. For example, the development of a standardized quality manual helps to streamline the process, by providing step-by-step protocols that must be met to achieve conformity with regulatory requirements. Leveraging tools like automated data collection can help bring costs down for conducting tests and checks, where testing has been pre-certified as meeting standard requirements. Additionally, engaging external compliance teams or consultants early in the process can help identify any potential problems quickly and provide advice on which steps are critical to addressing quality management issues. Assessing the Role of Third-Party Certifiers in Regulating these Devices. Third-party certifiers are an invaluable tool in the regulation of Class 3 medical devices. Not only do they allow manufacturers to have a comprehensive overview of the entire product development cycle and all its stages, but they also aid in certifying that requirements have been met as outlined by regulatory authorities. Additionally, they can provide valuable insights into which materials must be considered during the production process that may not necessarily be required by regulations, but would improve safety or efficacy. Ultimately, certification from third-party entities is an essential component for Class 3 medical devices to fully comply with applicable standards and regulations. Guidelines for manufacturers for Managing Risk and Adverse Events. The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

Introduction:

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements.

Class 3 medical devices are especially complex and pose the highest risk to patients. To ensure patient safety, manufacturers of class 3 medical devices must strictly follow guidelines issued by the FDA to achieve quality assurance during production. These guidelines include requirements related to design validation, process validation, labeling, sterilization, and more.

Understand the Regulatory Requirements of Class 3 Medical Devices:
Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations.

The regulatory requirements for Class III medical devices are outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which the FDA enforces. The FD&C Act defines the classification of medical devices based on their intended use, design, and potential risks. Class III medical devices are subject to the most stringent regulatory requirements, which include premarket approval (PMA), premarket notification (510(k)), post-market surveillance, and adverse event reporting.

The FDA also requires that Class III medical devices meet specific labeling requirements and have a unique device identification (UDI) system to facilitate tracking and reporting of adverse events. Failure to comply with these regulations can result in significant fines, legal action, and damage to your company’s reputation.

What is the FDA approval process for class III medical devices?

The FDA approval process for Class III medical devices is complex and lengthy, requiring significant resources, time, and expertise. The approval process ensures that medical devices are safe and effective for their intended use and meet the regulatory requirements outlined by the FDA.

The FDA approval process for Class III medical devices consists of several stages, including preclinical testing, clinical trials, and post-market surveillance. The preclinical testing stage involves testing the device in animal models and conducting bench studies to assess the device’s safety and effectiveness.

The clinical trial involves testing the device on human subjects to evaluate its safety and effectiveness. The clinical trial data is then submitted to the FDA for review and approval. Clinical trials are typically conducted in three phases, each involving more subjects and more rigorous testing.

Once the device has been approved, it must undergo post-market surveillance to monitor its safety and effectiveness in real-world settings. This involves tracking adverse events and conducting post-market studies to assess the device’s long-term safety and efficacy.

What is preclinical testing for class III medical devices?

Preclinical testing is critical to the FDA approval process for Class III medical devices. Preclinical testing involves conducting laboratory experiments and animal studies to evaluate the device’s safety and effectiveness before it is tested in humans.
Preclinical testing typically involves testing the device in animal models to assess its safety and efficacy.

This may include conducting toxicity studies, biocompatibility testing, and other tests to evaluate the device’s performance and potential adverse effects.

The results of preclinical testing are used to determine whether the device is safe to test in humans and to design the clinical trial protocol. Preclinical testing is a vital step in the approval process for Class III medical devices, and it helps to ensure that the device is safe and effective before it is tested in humans.

Why are clinical trials required for Class III medical devices?

Clinical trials are critical to the FDA’s approval process for Class III medical devices. Clinical trials involve testing the device on human subjects to evaluate its safety and effectiveness. Clinical trials typically involve more issues and more rigorous testing in three phases.

Why are there clinical trial phases for Class III medical devices?

Phase I clinical trials typically involve a small number of healthy volunteers. They are designed to assess the device’s safety and potential adverse effects.

Phase II clinical trials involve a more significant number of subjects. They are designed to evaluate the device’s effectiveness and safety in patients with the target condition.

Phase III clinical trials involve a more significant number of subjects. They are designed to confirm the device’s safety and effectiveness in a larger patient population. The results of the clinical trials are then submitted to the FDA for review and approval.

What are class III medical device post-market surveillance and adverse event reporting?

Post-market surveillance is critical to the FDA’s regulatory process for Class III medical devices. Post-market surveillance involves monitoring the device’s safety and effectiveness in real-world settings and tracking adverse events.

Medical device manufacturers must report adverse events to the FDA and maintain records of these events. The FDA uses this information to monitor the safety and effectiveness of medical devices and, if necessary, take action to protect public health.
Suppose a medical device manufacturer becomes aware of a problem with a device. In that case, they are required to report it to the FDA. Failure to report adverse events or maintain records can result in significant fines and legal action.

What are the labeling requirements for class III medical devices?

Class III medical devices are subject to specific labeling requirements designed to ensure that patients and healthcare providers have access to essential information about the device’s use, risks, and benefits.

The labeling requirements for Class III medical devices are outlined in the FDA’s Code of Federal Regulations (CFR) and include information such as the device’s intended use, indications for use, warnings, and precautions.

The labeling must also include a unique device identification (UDI) system, which facilitates tracking and reporting adverse events. The UDI system consists of a unique identifier assigned to each medical device, which must be included on the device’s label.

Pipedream....

Pipedream....

You are correct. This is taking longer than it should. Thom has ZERO sense of urgency. The one thing that Thom has made very clear without telling any of us . . . he will move and communicate at the pace he feels appropriate regardless of what those experts around him are suggesting.

Does anybody know anything that’s going on? Has anyone communicated with Thom?? I haven’t texted with him in a while.. seems like as ideal usual this is taking longer than usual. Thanks

It's crazy..... One would think you would have been talking with potential sponsors long before the FDA ever gave him the green light.

Thom is a joke. 6 weeks - give or take a few days - since the FDA has given the green light as long as UEEC has a babysitter. There should have been an update by now stating something to the effect of " final list of sponsor candidates selected. Decision by . . . date." or better yet ". . . entered agreement with sponsor . . . " All we get is crickets and a stagnant stock price.

At this pace, we can all place our bets on which quarter something happens, but don't try to guess the year other than some year in the future. I've driven past hog farms that stink less than Thom's ability to deliver.

Get it done Thom or be gone. That’s a message to the investment group that has been carrying us for the last two years. Either he produces now or get rid of his dumbbass.

Bingo - for all we know, a sponsor has been selected and they are prepping locations for surgeries. We will never know because Thom only tells us the bare minimum and it's always weeks to months after it occurred . . . just like with the latest FDA approval to proceed communication.

Thom seems to have ZERO interest in growing the value of this company along the way to FDA completion; which in the end hurts every one of us shareholders in terms of maximizing our ROI.

It’s because Thom‘s pattern never changes. Comes out with some generic, bullshit press release basically stating he’s accomplished nothing over the last six months and then you won’t hear from him again for another six months.

It’s a real shame every time we start to build a little momentum we lose it as a result of lack of follow through or lack of information

Can Thom ever accomplish anything without it taking 6 to 12 months? This guy either doesn't care or has no clue what he's doing.

This is a very common practice for owners / directors of smaller companies to use their own money to continue to fund operations when there is a lack of income. They fund through the purchase of stocks. I'm guessing this is what Brian has done after learning his lesson with White Lion.

More importantly, it's been 1 month and no update on a sponsor. What's taking so long for what would have already been a shortlist a month ago?!

From the time a sponsor is under contract, the process should take roughly 4 months (if everything goes smooth) before data is handed over to FDA for their review.

We are very quickly approaching the date where we will all be saying next year is the year.

When will the dickless morons in charge of this country start arresting the SEC? It’s the most useless fucking organization in this entire country who is bought off and they should all be in jail.

Someone buys four times the amount that is sold and we go down. I give you the corruption of market makers and how useless the SEC is.

FWIW the company CEO has had recent purchases that qualify as insider trading and were reported.
Insider Trades of THOM BRIAN DAVID
Officer, UNITED HEALTH PRODUCTS
4/08/2025 UNITED HEALTH PRODUCTS, INC. Officer Buy Direct 32,000 $0.24 1,104,671 View
3/31/2025 UNITED HEALTH PRODUCTS, INC. Officer Buy Direct 18,000 $0.26 1,072,671 View

Believe in the FDA supported opportunity in front of us!
$5-$10+

We can hope and pray but we’ve been here this long but… a year hopefully will be worth it..

We can hope and pray but we’ve been here this long but… a year hopefully will be worth it..

Yeah…You are right! If it’s one more year than we are good.

Yeah…You are right! If it’s one more year than we are good.

Trust if they’re ever getting their shit together it’s now.. a lot of delays.. I get it.. I’m in this for years..: you know what I’m doing??? I’m adding to my position because I believe that we will have a sponsor and they will get us to where we need to be…. If it is ever going to happen this will be it..
Everyone seriously cheer up.. we’ve been here a long time… if our time is coming this is it.. and I’m sorry to say this but if a year is the timeframe (and I hope it’s sooner) it will definitely be worth it.. an FDA approval is the answer to everyone’s prayers as far as in the world of UEEC. Good luck to us

I hear you Sterner. Very disappointed that approval hasn’t happened yet. I also put some of the blame on FDA, which has demonstrated with tons of different things that they are inept. Way too many clusterfucks running all kind of things in this country which is a shit show right now. All we can do is hang in there and hope we get a sponsor and FDA gets the fuck off our case.

Thanks guys. My friend posted on occasion, but it has been some time. It's just a shame that this has gone on this long. I am happy with recent changes and the gradual change in price. Still hopeful. I just don't want to be too old to enjoy the proceeds.

So sorry for your loss. Your friend will be watching down on us and will be celebrating with us in spirit someday. It's unfortunate that many of the past indicators failed to materialize, and us longs are still stuck here. I'm with you a win is due.

We might go higher if clowns stopped taking garbage profits at these low levels. Most likely people that don't know how to manage their finances properly. If the nickel and dimers would have some vision and stop taking little scraps, this thing would go back up to .35 to .50 cents.

Sorry for your loss Csterner. Was he a poster on this board? I think the same thing about several people including me that I know. It's absurd the buffoons in charge of this thing haven't been able to get approval in 15 fn years. Mind boggling.

First, let me say I’m sorry about your loss and I’m sorry your fellow shareholder who was obviously into the company is now unable to not only prosper but hopefully see something come together that we’ve been working on for a long time or at least start to come together, you get what I’m saying as far as you, my friend from what I understand, we all have some time left. Only God knows what lies ahead so let’s hope for the best. Let’s hope we all get to see the plan. Come together and profitability and sharing some profits.