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Dr. Norman
Estrin
is a
recognized authority in the medical device and cosmetic
industries. He has had over 30 years of experience in
directing scientific and technical and regulatory programs
in these industries. He is Regulatory Affairs
Certified (“RAC”) by the Regulatory Affairs Professional
Society. Dr. Estrin is the founder of ESTRIN CONSULTING
GROUP, INC. (ECG). ECG offers cost-effective,
experienced consulting to medical device firms on FDA-
related issues. Its Services include preparing 510(k)
and other FDA submissions, regulatory strategy development and
acting as agent and official correspondent for non-U.S. medical device
companies.
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If you have questions
related to the contents of this column, please write to Dr Norman Estrin at
yourFDAconsultant@medisourceasia.com
and he will try to answer you. This column is for you and we welcome your
suggestions on how to improve it. |
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Questions related to the Column
FDA
Regulations & Your Business |
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Q1. |
510 submissions for
the product has been on the market prior to May 28 1976
Just read your articles on 510 submissions Perhaps
you can answer this question. You mention that a 510(k) need not be
submitted if the product has been on the market prior to May 28 1976 . How
would you go about proving this to the FDA?
-Shelly
Nov. 05 , 2005
-Reply
from Dr. Norman Estrin |
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Q2. |
About regulations regarding storage and archiving of radiological images
What are the applicable regulations regarding companies that use, but do not manufacturer, devices classified under 21 CFR 892 2010 or 892.2020? Specifically the storage and archiving of radiological images. Are there specific regs that cover this type of service operation?
Tony Proctor , June 24 , 2004
-Reply From Dr Norman Estrin
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Q3. |
Radiological images and 820
Do companies that provide the service of storing medical radiological images fall under 820?
Tony Proctor , June 24 , 2004
-Reply From Dr Norman Estrin
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Q4. |
Are the Companies called Distributors?
They do not manufacture either the image storage equipment, communications equipment or the software but simply use this equipment to archive images. Other companies hold the registration. Are these companies considered distributors?
Tony Proctor , June 24 , 2004
-Reply From Dr Norman Estrin
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Q5. |
About regulatory control for software as Class I Medical Device
Also, at what point does software used in concert with a medical device come under regulatory control? I realize that stand-alone software is mostly Class 1 if the device can function without it, however what characteristics deem software a "medical device"? Does simply containing patient information constitute a medical device? If the software interfaces at ANY level with a device, is it a device?
Tony Proctor , June 24 , 2004
-Reply From Dr Norman Estrin
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Q6. |
About Medical Purpose Claims
Thanks for your helpful device series. My question is a device- esp. class I- is one that intended for a "medical purpose"- has FDA clarified what kinds of claims are "medical purpose" claims?
-Robert_Reinhard
Dated 14-04-2004
-Reply
from Dr. Norman Estrin
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| Q7. |
About Registration for
Cosmetic Dentistry Products
We are a company located in Millbrae,
California, specialized in the products for cosmetic dentistry. We have
contracted two products for manufacturing in China: plasmas arc dental
curing light and LED dental curing light. In order to bring in the products
for our distribution in the US Do we as an American company have to register
the two products?
-Philip Cheng, California
Dated 17-02-2004
-Reply
from Dr. Norman Estrin
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| Q8. |
About Validation
I being working for a company for a few years as production supervisor, we re-pack just class I devices, by my boss instructions, we send just one product of 25 products, every three months for the sterilization audit, we never send the other products to the Lab, when I asked, he told me the we just need to validate the worse product and it will cover the other products, is this correct? Thank you very much for your
time.
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Mymstg
Dated 22-01-2003
-Reply
from Dr. Norman Estrin
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