For medical applications, FDA certification according to 21 CFR 177.1550 is an absolute must. The materials used in our SMC product series PEAPP, TD, TH, TL, LQ3, LVD, PAB, PF and LVQ meet the required FDA regulations of § 177.1550. This means: All our PFA articles in the product lines pumps, tubing and valves are made of materials that meet the FDA regulations.
Who is the FDA?
The FDA (Food and Drug Administration) is a U.S. agency responsible for the approval and market surveillance of food, drugs and medical devices.
FDA guidelines specify which materials, equipment and tools may be used when handling certain classes of products. The aim here is to achieve product purity and avoid certain contamination by pathogens such as mold.
Approval by the FDA thus certifies that
- the benefits of a product outweigh the known risks,
- the relevant FDA requirements are met
- and that there is no risk to end users when the product is used properly.
Special requirements in the life science sector
Part of the life science sector is medical technology. Companies in this sector, for example dental technicians or manufacturers of equipment for analyzing blood, proteins and urine, need a reliable, competent partner at their side. FDA approval also becomes necessary for companies that produce food (e.g. breweries and manufacturers of other beverages).
Not all suppliers are FDA-certified, or their products only have insufficient certification. For customers, this can lead to problems with authorities or they may not even be able to use the products in question.
With the SMC product series mentioned above, however, you are on the safe side: Since the materials used meet the requirements of FDA certification § 177.1550, you can be sure that there will be no contamination by our products and that your approvals will be approved without any problems.
Are you interested in details of our FDA-certified product series? Contact us – our team will be happy to answer your questions.