Are there any FDA-approved measuring instruments?

Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Learn more in the following blog post. You can find always uncertainties with this topic, which explains why I?d prefer to shed more light on the question in this blog post.
What’s the FDA?
The FDA (?Food and Drug Administration?) is a US authority under the Department of Health. It is responsible for the tabs on foodstuffs and pharmaceuticals and serves to protect public health in the United States.
When should FDA requirements be looked at?
The FDA?s control includes both US-made and imported products. For this reason, regular audits are completed at overseas pharmaceutical manufacturers. US-approved drugs may only be produced by FDA-inspected manufacturers whose facilities comply with FDA regulations.
How are plants and equipment assessed for FDA requirements?
The FDA does not grant approval for measuring instruments. The assessment is completed relative to general GMP requirements (?good manufacturing practice?). These must already be taken into account in the planning of the plant as must the selection of suitable measuring instruments:
Liquids that could find their way in to the end product in case of a failure must be FDA-compliant. These can, for example, be transmission fluids or fill fluids.
Seals that are in contact with the measuring medium should be manufactured from FDA-compliant material. As proof, a material certificate for the seal must be available.
Process connections should ideally have 3-A approval to ensure the connections are suitable for sanitary applications. Instruments with 3-A marking have been shown to meet up with the specifications for radii and surface roughness (Ra < 0.8 ?m).
Metallic parts which come in contact with the media must have a 3.1 material test certificate relative to DIN EN 10204. In sterile engineering, it really is better use CrNiMo steels, of quality 1.4404 and 1.4435 or 316L. (For instance, WIKA uses 1.4435 as the standard material for applications in sanitary applications, because it has improved corrosion properties compared to 1.4404 because of the lower delta ferrite content).
Off-the Record measuring instrument should be calibratable and the accuracy should be confirmed by 3.1 or DAkkS certificate.
Conclusion
Nothing will stand in the form of the success of one’s FDA audit, so long as you take these points into account.
Note
Further information on our products can be found on the WIKA website.

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