{"id":9316,"date":"2019-08-30T13:05:39","date_gmt":"2019-08-30T11:05:39","guid":{"rendered":"https:\/\/blog.wika.com\/en\/?p=9316"},"modified":"2022-02-10T10:32:13","modified_gmt":"2022-02-10T09:32:13","slug":"are-there-any-fda-approved-measuring-instruments","status":"publish","type":"post","link":"https:\/\/blog.wika.com\/en\/knowhow\/are-there-any-fda-approved-measuring-instruments\/","title":{"rendered":"Are there any FDA-approved measuring instruments?"},"content":{"rendered":"

Does the FDA issue its own approvals for systems or devices and therefore also issue approvals for measuring devices? Find out more in the following blog post. There are always uncertainties with this topic, which is why I’d like to shed more light on the question in this blog post.<\/strong><\/strong><\/p>\n

What is the FDA?<\/h2>\n

The FDA (\u201cFood and Drug Administration\u201d) is a US authority under the Department of Health. It is responsible for the monitoring of foodstuffs and pharmaceuticals and serves to protect public health in the United States.<\/p>\n

When should FDA requirements be considered?<\/h2>\n

The FDA’s control includes both US-made and imported products. For this reason, regular audits are carried out at overseas pharmaceutical manufacturers. US-approved drugs may only be produced by FDA-inspected manufacturers whose facilities comply with FDA regulations.<\/p>\n

How are plants and equipment assessed for FDA requirements?<\/h2>\n

The FDA does not grant approval for measuring instruments. The assessment is carried out in accordance with general GMP requirements (\u201cgood manufacturing practice\u201d). These must already be taken into account in the planning of the plant as must also the selection of suitable measuring instruments:<\/p>\n