FDA Definition of "Raw Material"

R

ryno fan

#1
Hi,

Does anyone know of FDA's definition of "raw material"?

Are there guidance documents or regulations applicable to raw material?

Is "raw material" in FDA terms, only applicable to drugs?

Thanks
 
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M

MIREGMGR

#2
Re: FDA meaning of "raw material"

I'm not sure what your context or underlying question might be.

For devices, FDA does have Recognized Consensus Standards that define the chemical and physical nature and characteristics of a number of materials, which might be considered "raw materials".
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Re: FDA meaning of "raw material"

Hi,

Does anyone know of FDA's definition of "raw material"?

Are there guidance documents or regulations applicable to raw material?

Is "raw material" in FDA terms, only applicable to drugs?

Thanks
I think for drugs (instead of raw materials) they call it "API starting materials" (where the API stands for active pharmaceutical ingredient):

API Starting Materials: A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure.

Active Pharmaceutical Ingredient: Any substance or mixture of substances indended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance

Brian :rolleyes:
 
Last edited:
R

ryno fan

#4
Re: FDA meaning of "raw material"

Basically, we manufacture medical device software. We have vendors contracted to perform our coding and some testing. If the vendors are not producing a finished device (because we may add specs to it later to satisfy customer needs (as design changes), does raw material have anything to do with this? I am thinking raw material would only apply if they were actually building microchips for us or similar...
 

insect warfare

QA=Question Authority
Trusted Information Resource
#5
Re: FDA meaning of "raw material"

Basically, we manufacture medical device software. We have vendors contracted to perform our coding and some testing. If the vendors are not producing a finished device (because we may add specs to it later to satisfy customer needs (as design changes), does raw material have anything to do with this? I am thinking raw material would only apply if they were actually building microchips for us or similar...
If you manufacture medical device SW, and you outsource the code and testing through approved vendors, they are actually supplying you with a tested component, which are the software bundles. I don't know your operation, but are you also handling the medium which the software is imprinted onto, such as a disk? You may have another vendor who supplies you with those. Together these are all raw materials that go into a finished product, which (in this case) would be a disk that contains the specific SW configurations.

Brian :rolleyes:
 
R

ryno fan

#6
Thanks Brian (insect warfare).

In your example, do "raw materials" have the same meaning as "component" in the FDA regulations?

And which FDA regulations apply to raw materials? (for example, 820.50 Purchasing Controls, 820.80 Receiving Acceptance) Others?

Are you aware of any guidance documents specific to controlling raw materials as in your example (software)?

Any help is appreciated.

(I find this forum of great value...) :applause:
 

insect warfare

QA=Question Authority
Trusted Information Resource
#7
In your example, do "raw materials" have the same meaning as "component" in the FDA regulations?
In this context I think they do:

From 820.3c - (Definitions)
Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

And which FDA regulations apply to raw materials? (for example, 820.50 Purchasing Controls, 820.80 Receiving Acceptance) Others?
Technically, raw materials could apply anywhere where the term “product” (or “components”) is used. You would need to sift through the 21CFR requirements and make those determinations of applicability.

Are you aware of any guidance documents specific to controlling raw materials as in your example (software)?
Not to my knowledge. I did a Google search and could not find anything pertaining to my example, but I would re-read 21CFR 820.1 – (Scope) and 820.30a(2) – (Design Controls) for more information specific to your operation.

Brian :rolleyes:
 
R

revolution_2006

#8
ryno fan,
As the prior posts indicated, software is certainly considered a component of a medical device (or a medical device on its own, as applicable) and therefore requires the same controls as applied elsewhere in your company for your medical device.
The control of the raw material/component, in your case outsourced software or software modules/ assessments, would fall under your general purchasing controls. The primary standards for software control would be defined within the FDA Harmonized standard ISO 62304, and the general principals of software validation guidance from the FDA, GHTF and other agencies, as applicable. Some of the ones I have utilized in the past few years include:
? 21 CFR 820.30, Quality System Regulation, Design Control
? Design Control Guidance For Medical Device Manufacturers (March 11, 1997),
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
? Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff (05/11/2005)
Guidance for Off-the-Shelf Software Use in Medical Devices (09/09/1999)
? Applicable EU directive (i.e. 90/385/EEC Council Directive of June 20, 1990 relating to active implantable medical devices ? Active Implantable Medical Device Directive (as amended by directive 2007/47/EC, 21-Sep-2007, and previous)
? EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
? ISO 14971:2007 ? Medical devices ? Application of risk management to medical devices
? EN 60601-1:2006/AC:2010 for Programmable Medical Software (?14)
? IEC 62304:2006 Medical device software ? Software life cycle processes

I would ensure that your supplier controls for the subcontractor are well defined. You may want to consider reviewing Appendix 2 of Guidance for Notified Bodies Auditing Suppliers to Medical Device Manufacturers for some important considerations to include in your contract with the outsourced partner that may help demonstrate adequate control during your next audit.

Raw material and software is also mentioned in the preamble for the QSR as a component. Anyway, just my :2cents:
 
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