Business Law

Ask a business lLawyer. Get business law questions answered ASAP.

Ask a Lawyer,
Get an Answer ASAP!

This answer was rated:

We are a new Class I medical device and are setting up our…

We are a new...

We are a new Class I medical device and are setting up our Ecommerce website for customers to place orders. The product is listed as prescription only, and thus only registered clinicians are allowed to order it. What process must we follow to allow clinicins to purchase our product?

Lawyer's Assistant: What state are you in? It matters because laws vary by location.

PA

Lawyer's Assistant: Has anything been filed or reported?

Our company is registered with the FDA as a Class I device.

Lawyer's Assistant: Anything else you want the lawyer to know before I connect you?

No - we assume that they would have to put in their medical license # (NPI #). But are we required to?

Show More
Show Less
Ask Your Own Business Law Question
Customer reply replied 1 month ago
Hello - is someone working on my question?
Answered in 6 days by:
3/12/2018
WiseOwl58
WiseOwl58, Attorney
Category: Business Law
Satisfied Customers: 4,414
Experience: Senior Associate at White & Case LLP
Verified

The clinician would have to put in their furnishing number (which gives them the right to prescribe). Once the clinician puts in the number, he can place the order.

Please rate five stars ***** by clicking on five stars ***** and press SEND.

A bonus is appreciated after you rate.

Good luck to you. I wish you all the best.

Ask Your Own Business Law Question
Customer reply replied 1 month ago
Is that a requirment of the FDA? Because of the prescription? If we were to remove the prescription status (device is Class I exempt), can we then remove the NPI # to order?

No, it's not FDA required. You can remove the prescription status, then you don't need to collect the NPI.

Please rate five stars ***** by clicking on five stars ***** and press SEND.

A bonus is appreciated after you rate.

Good luck to you. I wish you all the best.

WiseOwl58
WiseOwl58, Attorney
Category: Business Law
Satisfied Customers: 4,414
Experience: Senior Associate at White & Case LLP
Verified
WiseOwl58 and 87 other Business Law Specialists are ready to help you
Ask your own question now
Customer reply replied 1 month ago
Thank you! Yes, that is what we decided after speaking to several sources.
Was this answer helpful?
Ask WiseOwl58 Your Own Question
WiseOwl58
WiseOwl58
WiseOwl58, Attorney
Category: Business Law
Satisfied Customers: 4,414
4,414 Satisfied Customers
Experience: Senior Associate at White & Case LLP

WiseOwl58 is online now

A new question is answered every 9 seconds

How JustAnswer works:

  • Ask an ExpertExperts are full of valuable knowledge and are ready to help with any question. Credentials confirmed by a Fortune 500 verification firm.
  • Get a Professional AnswerVia email, text message, or notification as you wait on our site. Ask follow up questions if you need to.
  • 100% Satisfaction GuaranteeRate the answer you receive.

JustAnswer in the News:

Ask-a-doc Web sites: If you've got a quick question, you can try to get an answer from sites that say they have various specialists on hand to give quick answers... Justanswer.com.
JustAnswer.com...has seen a spike since October in legal questions from readers about layoffs, unemployment and severance.
Web sites like justanswer.com/legal
...leave nothing to chance.
Traffic on JustAnswer rose 14 percent...and had nearly 400,000 page views in 30 days...inquiries related to stress, high blood pressure, drinking and heart pain jumped 33 percent.
Tory Johnson, GMA Workplace Contributor, discusses work-from-home jobs, such as JustAnswer in which verified Experts answer people’s questions.
I will tell you that...the things you have to go through to be an Expert are quite rigorous.

What Customers are Saying:

Mr. Kaplun clearly had an exceptional understanding of the issue and was able to explain it concisely. I would recommend JustAnswer to anyone. Great service that lives up to its promises!

Gary B.Edmond, OK

My Expert was fast and seemed to have the answer to my taser question at the tips of her fingers. Communication was excellent. I left feeling confident in her answer.

EricRedwood City, CA

I am very pleased with JustAnswer as a place to go for divorce or criminal law knowledge and insight.

MichaelWichita, KS

PaulMJD helped me with questions I had regarding an urgent legal matter. His answers were excellent.

Three H.Houston, TX

Anne was extremely helpful. Her information put me in the right direction for action that kept me legal, possible saving me a ton of money in the future. Thank you again, Anne!!

ElaineAtlanta, GA

It worked great. I had the facts and I presented them to my ex-landlord and she folded and returned my deposit. The 50 bucks I spent with you solved my problem.

TonyApopka, FL

Wonderful service, prompt, efficient, and accurate. Couldn't have asked for more. I cannot thank you enough for your help.

Mary C.Freshfield, Liverpool, UK

< Previous | Next >

Meet the Experts:

Infolawyer

Infolawyer

Attorney

1,851 satisfied customers

Experienced lawyer

Dimitry K., Esq.

Dimitry K., Esq.

Attorney

1,611 satisfied customers

Run my own successful business/contract law practice.

MShore Law

MShore Law

Attorney

1,233 satisfied customers

Drafted Negotiated and/or Reviewed Thousands of Commercial Agreements

RGMacEsq

RGMacEsq

Attorney

751 satisfied customers

Licensed Texas General Practice Attorney

Barrister

Barrister

Attorney

646 satisfied customers

17 years practicing attorney, JD, BA, MBA

Ely

Ely

Attorney

577 satisfied customers

Counselor at Law.

J.Hazelbaker

J.Hazelbaker

Attorney

393 satisfied customers

Experienced and trained in the area of business law.

< Previous | Next >

Related Business Law Questions
We are a new Class I medical device and are setting up our
We are a new Class I medical device and are setting up our Ecommerce website for customers to place orders. The product is listed as prescription only, and thus only registered clinicians are allowed … read more
WiseOwl58
WiseOwl58
Attorney
4,414 satisfied customers
Import of the traditional herb: "bitter leaf" into the US.
Import of the traditional herb : "bitter leaf" into the US. If all labeling is according to the FDA law does it needs an FDA import license as a food supplement? Or can it be freely imported?… read more
WiseOwl58
WiseOwl58
Attorney
4,414 satisfied customers
I'm looking into importing ice cream premix powder from the
I'm looking into importing ice cream premix powder from the far east since I plan to open my own store (the reason being new flavors and cheaper prices) but I am not sure whether I need to get any pre… read more
WiseOwl58
WiseOwl58
Attorney
4,414 satisfied customers
I am intending to bring few cosmetics on the market and put
I am intending to bring few cosmetics on the market and put the ingredients, directions, etc as OTC but do not register as an OTC product. I believe that is OK but like to have confirmation.… read more
Lori
Lori
Juris Doctor
1,076 satisfied customers
I'm starting an herbal supplement business and want to know
I'm starting an herbal supplement business and want to know about all the licenses, permits and registrations I should have. I can provide more details once we speak.… read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
Do I need liability insurance to sell homemade organic
Do I need liability insurance to sell homemade organic lipbalm … read more
WiseOwl58
WiseOwl58
Attorney
4,414 satisfied customers
CLASS ACTION ATTORNEY PLEASE. Currently there are, or going
CLASS ACTION ATTORNEY PLEASE. Currently there are, or going to be, or have been class action suits concerning the drug Mirapex. Mirapex is now well known to have devastating effects on those who take … read more
WiseOwl58
WiseOwl58
Attorney
4,414 satisfied customers
I have a bar in New Rochelle and I'm interested in getting a
I have a bar in New Rochelle and I'm interested in getting a hookah license … read more
Damien Bosco
Damien Bosco
4,179 satisfied customers
I'm looking into getting into the nootropic business but
ma'am, I'm looking into getting into the nootropic business but instead of doing a store front I'm looking to do a more personalized approach. … read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
Do I need a certificate of analysis to sell herbal
Do I need a certificate of analysis to sell herbal supplements? I wanted to start selling some, but an analysis may be prohibitively expensive, and I'm having a hard time finding a company that does t… read more
Damien Bosco
Damien Bosco
4,179 satisfied customers
Try and find out what licensing I need to open a vape shop,
Try and find out what licensing I need to open a vape shop … read more
Damien Bosco
Damien Bosco
4,179 satisfied customers
Ray, Do you feel like David? Take on Goliath? I am a
Ray, Do you feel like David? Take on Goliath? I am a physician and feel the FDA must have been paid off by big pharma to get approval for Repatha. This drugs dramatically lowers cholesterol and accord… read more
Ray
Ray
Lawyer
Doctoral Degree
32,117 satisfied customers
I was hoping to get more expert advice on this question that
Hi, I was hoping to get more expert advice on this question that was previously asked:http://www.justanswer.com/business-law/8emdd-sell-etizolam-powder-online-long-disclaimer.html There seem to be a l… read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
I have a personal lubricant I would like to start marketing.
I have a personal lubricant I would like to start marketing. Do I need FDA approval? I've been told if I label it for men only that I do not need FDA approval.… read more
KLAW
KLAW
Juris Doctorate
2,044 satisfied customers
I recently paid a FDA/GMP certified company in California to
I recently paid a FDA/GMP certified company in California to make my alcohol based tincture recipes so that I can sell them online. My LLC is registered in Colorado and I am trying to find out whether… read more
KLAW
KLAW
Juris Doctorate
2,044 satisfied customers
My partner and I are starting an online handmade skin care
Hello, My partner and I are starting an online handmade skin care shop. We live in different states (NY and NJ). How does this work in regards ***** ***** IDs and sales tax?… read more
KLAW
KLAW
Juris Doctorate
2,044 satisfied customers
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 t… read more
Richard - Bizlaw
Richard - Bizlaw
Juris Doctor
3,750 satisfied customers
Under FDA cosmetics claims guidelines, no claims can be made
Hi,Under FDA cosmetics claims guidelines, no claims can be made as a cosmetic regarding structural changes to the skin without being classified as a drug.Am I responsible for the reviews that are left… read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

Show MoreShow Less

Ask Your Question

x