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FDA Approval

Roderick Ray

#23502

FDA Approval | 24 February, 2003

I would like to find out what it would take to get a small prototype SMT shop FDA approved. Any informationn would be appreciated.

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MA/NY DDave

#23503

FDA Approval | 24 February, 2003

Hi

Let me just give a little and someone else might chip in with fast and ready details.

I don't know what your product or service is, so I am not sure how direct to the FDA you need to be for your shop. If you work for someone they should handle this topic.

From what I know usually you hire someone that really knows the FDA system and can get you up to speed fast. Throughout the year there are classes on Best Practices and Certification and if I could remember fast I would give you the acronmyn for the latest and greatest. GM???

Piles of resources on the web, and magazines as well depending on your product and it's application.

YiEng, MA/NY DDave

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#23505

FDA Approval | 24 February, 2003

Key Food and Drug Administration [FDA] Compliance Guidelines are in: * Blood/Biotechnology * Cosmetics * Drugs * Food * Medical Devices * Positron Emission Tomography

The medical device industry adheres to the rules of Good Manufacturing Practice (GMP), which are set out in the Code of Federal Regulations (CFR) by the Food and Drug Administration (FDA) of the USA.

GMP / QSR (21 CFR Parts 820 Medical Devices; Current Good Manufacturing Practice (cGMP) Final Rule, Quality System Regulation, Oct. 7, 1996

21 CFR Parts 820 Table of Contents 21 CFR 820.1 Scope 21 CFR 820.5 Quality System 21 CFR 820.20 Management Responsibility 21 CFR 820.22 Quality Audit 21 CFR 820.25 Personnel 21 CFR 820.30 Design Controls 21 CFR 820.40 Document Controls 21 CFR 820.50 Purchasing Controls 21 CFR 820.60 Identification 21 CFR 820.65 Traceability 21 CFR 820.70 Production and Process Controls 21 CFR 820.72 Inspection, Measuring, and Test Equipment 21 CFR 820.75 Process Validation 21 CFR 820.80 Receiving, In-Process, and Finished Device Acceptance 21 CFR 820.86 Acceptance Status 21 CFR 820.90 Nonconforming Product 21 CFR 820.100 Corrective and Preventive Action 21 CFR 820.120 Device Labeling 21 CFR 820.130 Device Packaging 21 CFR 820.140 Handling 21 CFR 820.150 Storage 21 CFR 820.160 Distribution 21 CFR 820.170 Installation 21 CFR 820.180 General Requirements 21 CFR 820.181 Device Master Record 21 CFR 820.184 Device History Record 21 CFR 820.186 Quality System Records 21 CFR 820.198 Complaint Files 21 CFR 820.200 Servicing 21 CFR 820.250 Statistical Techniques

Here�s a sample GMP manual: http://www.fda.gov/cdrh/dsma/gmp_man.html

In reviewing 21 CFR 820, the shrewd observer will notice an eerie similarity to ISO-9000. FDA �xeroxed� ISO-9000 and then patched-on their own peculiar requirements, similar to what the US BIG automobile sellers did with QS-9000.

So, after you line yourself-up with these Good Manufacturing Practices, you request that a FDA audit certify your compliance to those requirements. The FDA re-audits you every year, similar to the ISO-9000 certification process.

To learn more: * Root around the FDA site * Search the web * Buy books at your favorite bookstore or on Amazon.com

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#23510

FDA Approval | 25 February, 2003

One addition to Dave's comments.....my previous experience yielded one key observation about the differences between ISO audits and GMP (FDA) audits: ISO audits were to establish that you had a documented process, complete with procedures, established record keeping systems, qualification and validation systems, etc.

The GMP audits matched that, but also verified that you were using the systems, i.e., they looked through your records to make sure that you did your maintenance on schedule, and that if you didn't, you had records of the equipment being red-tagged (offline) for the lapse period....either that, or you 100% visually inspected everything that might have been affected by the lapse.

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MA/NY DDave

#23512

FDA Approval | 25 February, 2003

Hi,

Good Notes from others.

A few web sites of the piles available. http://www.imdmc.org Indiana Medical Device Mfgs Council http://www.mmda.org Michigan's

http://www.raps.org Regulatory Affairs Professional Society

The last time I was involved the FDA approval for the manufacturer was handled by the OEM. I was in a large CEM who was a subcontractor for a portion of the product.

The OEM had the FDA knowledgable and connected person. Connection, and credibility was almost more important than knowledge from what I gathered.

From what I have read, unless you really want to spend the time or your product is your own, hiring a person in this industry is the best way to get started.

I don't have the brochures yet there are training classes on the GM??? processes, which I think I noted above. They are expensive. I say GM?? because if I remember right there are variants.

YiEng, MA/NY DDave

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#23515

FDA Approval | 25 February, 2003

http://www.fda.gov/cdrh/devadvice/32.html is another good basic read.

One of the meatiest things to come out of the '96 release of the QSR (Quality Systems Regulations) was more emphasis on design as a contributor to quality. It's nice to have the 'gov' on your side.

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#23516

FDA Approval | 25 February, 2003

And the really sad part about that is: Some organizations actually REQUIRED a institutionally myopic organization like the FDA to go "Hello, design has a BIG impact on quality and you HAVE to pay more attention to that area".

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MA/NY DDave

#23561

FDA Approval | 27 February, 2003

Hi

Hey just found a guide to some of the members and companies in this field. If you haven't already found someone or two to call and ask for consultant prices to help you get FDA approval tell me where you live and I will pick two or three from this directory.

YiEng MA/NY DDave

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