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Recent FDA questions

I have a question about FDA (Food & Drug Administration)

I have a question about FDA (Food & Drug Administration) compliance for medical devices.I own an algorithm that detects beat location and rhythm abnormalities in an ECG signal. My intent is to sell this to medical hardware manufacturers to put inside their products. Is 510(k) clearance for my software library mandatory (or even possible)? Or is this only done by the manufacturer that uses my library?

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Richard - Bizlaw

Juris Doctor

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Making a mobility assistance device people. It as attachment

Making a mobility assistance device for blind people. It as attachment to the white can. What are the laws/regulations manufacturers have to follow to make this product? are there any laws for products for disabled people?

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Richard - Bizlaw

Juris Doctor

9,802 satisfied customers
I'm planning to import a new line of skin care products and

I'm planning to import a new line of skin care products and I need FDA approval. Doing some research in the FDA website I've read that some of my products are both cosmetics and a drug. So what do I need to do to get my products FDA approved to be sold in the US?The products are already being sold in Mexico and I plan to private label them and sell them here.

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Law Educator, Esq.

Attorney At Law

Doctoral Degree

108,100 satisfied customers
Not sure what expert is available, but here goes: I am

Not sure what expert is available for this, but here goes: I am amazed at people who, for example, bake something their grandma made and they start off small, but then grow to where they need a large area with lot of commercial equipment to make their item, which is placed in stores and sold on line. Where, how, when does one start such a business? What about health certificates when item is made at home, etc. What else is needed? How does one get the product in large grocery stores? What goes on the label? Where do we get information that goes on the label, such as ingredients, calories, nutritional value, etc.? Is there a site for such information of starting a new food business? What are your thoughts, and suggestions?

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Law Educator, Esq.

Attorney At Law

Doctoral Degree

108,100 satisfied customers
My question is regarding labels in the cosmetics/skincare

My question is regarding labels in the cosmetics/skincare industry. I know there are regulations in using the word 'organic'. However, are there any regulations that I should be aware of when using the terms 'Pure' and 'Natural'?

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Law Educator, Esq.

Attorney At Law

Doctoral Degree

108,100 satisfied customers
I have a small business selling electric kegel toners

I have a small business selling electric kegel toners online. My business license is sole proprietor. This is not a medical device, it is a fitness device. It is not FDA approved. It is CE approved, which is the UK's version of the FDA. I am not the manufacturer, I am only a distributor. I bought these devices from a company in China. My anticipated profit on the inventory I have is about $8,000. I got a quote for insurance and it came back at $8,400 a year. My question is; do I need product liability insurance? What is my liability? The device runs on a 9v battery. The risk of injury is almost non-existent, but psychos can get hurt with a glass of water. Should I save the money and simply pay a lawyer to defend me if a psycho tries to sue?

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MDLaw

Attorney

Post-Doctoral Degree

4,330 satisfied customers
1) What are the requirements online seller to

1) What are the requirements for an online seller to lawfully sell fda approved type 2 medical devices in the State of NY? 2) What are the requirements to accept prescriptions, but not health insurance

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Law Educator, Esq.

Attorney At Law

Doctoral Degree

108,100 satisfied customers
Following, I want to be personally protected and not

For the following, I want to be personally protected and not liable with my own personal assets.That's the primary goal.I am a non US resident and will be selling supplements on Amazon USA, that I will have manufactured by an FDA approved US manufacturer.I don't want to start a US LLC right now, since I probably won't be able to open a bank account for it as a non resident.If I start a UK LTD, that will have a PayPal account. I personally pay the UK LTD on its PayPal account to order the supplements, the UK LTD pays the US manufacturer and has the supplements manufactured (the brand on the bottles will be the UK LTD) and has them shipped to Amazon. I sell them on Amazon (through my personal seller account) and Amazon pays me.If someone wants to sue 'me' for the supplements or anything related to it, will I then be protected, or personally liable?And if not, what should I change in this approach?thanks!

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5,238 satisfied customers
Google was awarded patent #9,051,043 on June 9, 2015 entitled

Google was awarded patent #9,051,043 on June 9, 2015 entitled "Providing emergency medical services using unmanned aerial vehicles". I own the patents and trade secrets on the lightest and smallest chemically created oxygen generators in the world and am about to resume manufacturing after a 9 year hiatus. Our generators produce medical grade oxygen (USP) and are approved by the FDA for sale over the counter (OTC) without a prescription. The technology is also approved by the FAA and was used in over 500,000 Flight Attendant "walkarounds" for passengers in distress and Flight attendant mobility.We have never found a delivery method until UAVs. How do we connect with appropriate Google people and invite them to review our products and how they fit the UAV-delivery marketplace?Kenneth J. PalmerChairman & CEOStand-By Systems, Inc (a 23 year old Texas corporation) ***@******.***

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Law Educator, Esq.

Attorney At Law

Doctoral Degree

108,100 satisfied customers
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