Silicone products with FDA registration

Since 2020, Silikon-Technik Siltec has been registered as a contract manufacturer of medical devices with the FDA. The FDA – the US authority for food and drugs (“Food and Drug Administration”) – monitors and administers the approvals of medical products on the US market. With the FDA registration, Siltec can produce medical silicone articles for the US market as a contract manufacturer.

For registration as a contract manufacturer, Siltec’s quality management system must meet the requirements of FDA 21CFR Parts §820 and §807. To meet this quality standard, Siltec has adapted various procedures within the company to meet the necessary requirements. For example, there is now a clearly defined process for process validation of silicone molded parts when this is required for the manufacture of a silicone product registered with the FDA.

Siltec can manufacture silicone products with FDA registration for customers using both silicone injection molding and/or silicone extrusion. This includes silicone molded parts, silicone tubing and silicone gaskets. Ready-to-use items such as ventilation tubing or assemblies can also be manufactured by agreement with the customer. In addition, Siltec can provide end-user packaging or packaging under clean room conditions by agreement.

With the registration, Silikon-Technik Siltec acts as a contract manufacturer (“Contract Manufacturer”) for the corresponding silicone products in the US market. The distribution of the products and accessories (“Legal Manufacturer”) remains with our customers.

Are you interested in our products and services?

Silikonformteile mit FDA Anmeldung

Manufacturer of silicone products with FDA registration

Siltec is already registered with the FDA as a contract manufacturer of silicone products for several customers. Among them, Siltec produces these products with respective FDA classification:

  • Silicone molded part: a menstrual cup under the category “CUP, MENSTRUAL” (HHE)

  • Silicone molded part: a test lung for ventilators, under the category “BAG, RESERVOIR” (BTC)

  • Ready-made article made of a silicone spiral tube with sleeves attached by LSR: “CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)” (CAI) and “SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)” (BZO)

Currently, Siltec is also in coordination with customers for the registration of various silicone seals (sealing caps) for medical devices. The FDA registration of Siltec can be viewed here

Silicone products manufacturer according to the standard FDA 21CFR Part §820

The U.S. Food and Drug Administration (FDA) has one of the world’s strictest quality requirements for manufacturers of medical devices. A large number of countries therefore require a quality management system that complies with the FDA standard for market approval. Siltec can meet this quality standard for customers – set by the FDA 21 CFR Part §820.

This means, for example, that Siltec can perform a process validation for the production of silicone molded parts after consultation and agreement with the customer’s quality team. In this process validation, the production of the silicone product is checked in specific, critical process scenarios with detailed quality controls.

Siltec thus offers customers the possibility to produce silicone products as contract manufacturer for markets beyond Europe. In particular, Siltec can produce silicone products for customers that want to export to the US market.

Silikonschläuche-FDA-Silikon-BeatmungsschläucheSilikonschläuche-FDA-Silikon-Beatmungsschläuche
Silikonprodukte QualitätskontrolleSilikonprodukte Qualitätskontrolle

Further legal standards for medical silicone parts

Siltec’s production has had ISO 13485 certification for the manufacture of silicone medical devices for a number of years. Siltec is inspected in detail annually by an independent inspection company to maintain this certification. The requirements of the new MDR can be met, too.

Depending on the requirements, Siltec also offers components according to these standards and certificates:

  • USP Class VI and EP 3.1.9

  • ISO 10993 (e.g. for cytotoxicity or skin irritation)

  • BfR XV and FDA §177.2600

  • RoHs

  • REACH

The required conformity depends on the respective area of application and the requirements of the component. We will be happy to advise you on this with our experience and expertise.

Are you interested in our products and services?