FDA Approval

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

This message was posted the Electronics Forum @

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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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