In the medical industry, silicone rubber has become an ideal material for manufacturing medical devices, implants and medical consumables due to its excellent biocompatibility, high-temperature resistance and chemical stability. However, medical-grade silicone rubber must pass strict FDA (Food and Drug Administration of the United States) certification to ensure its safety and compliance. As a professional silicone products factory, we are well aware of the significance of FDA certification and would like to share here the key points on how medical-grade silicone rubber can meet FDA standards.
What is FDA certification?
FDA certification is the safety assessment of products such as medical devices, food contact materials and drug packaging by the U.S. Food and Drug Administration. For medical-grade silicone rubber, FDA certification means that the material complies with the relevant requirements of 21 CFR (Federal Regulations of the United States), especially:
21 CFR 177.2600 (Rubber products used as reusable food contact materials)
②USP Class VI (United States Pharmacopeia Class VI Biocompatibility Test)
③ISO 10993 (International Standard for biocompatibility testing)
Silicone rubber materials certified by the FDA can be safely used in human contact or implantable medical products.
FDA certification requirements for medical-grade silicone rubber:
(1) Raw material selection
The primary condition for FDA certification is the use of high-purity medical silicone raw materials, typically platinum vulcanized silicone (LSR) or high-temperature vulcanized silicone (HCR), ensuring that the material is non-toxic, non-irritating, and free of harmful plasticizers (such as phthalates) and heavy metals (such as lead and cadmium).
(2) Biocompatibility test
Medical-grade silicone rubber must pass USP Class VI or ISO 10993 biocompatibility tests, including:
Cytotoxicity test (to ensure that the material does not cause damage to cells)
Skin irritation test (to ensure no allergic reactions or irritation)
Sensitization test (to assess whether long-term exposure will cause an allergic reaction)
Implantation testing (applicable to products that have been implanted in the human body for a long time)
(3) Chemical stability
The FDA requires that silicone rubber does not release harmful substances when it comes into contact with blood, body fluids or drugs. Therefore, extraction tests are needed to ensure that the material remains stable in extreme environments such as high-temperature sterilization and strong acid and strong alkali environments.
(4) Production process control
Silicone product factories must comply with GMP (Good Manufacturing Practice) standards, ensure a clean and pollution-free production environment, and establish a strict quality traceability system, with every link from raw materials to finished products traceable.
How to ensure that silicone rubber products pass the FDA certification?
As a professional silicone products factory, we take the following measures to ensure product compliance:
1. Select FDA-certified silicone raw materials to ensure that the basic materials meet the standards.
2. Strictly control the production process to avoid cross-contamination and ensure the cleanliness of the products.
3. Conduct third-party testing and entrust authoritative laboratories to carry out biocompatibility tests.
4. Provide complete compliance documents, including FDA certification certificates, biocompatibility reports, etc.
FDA certification is an important threshold for medical-grade silicone rubber to enter the international market. Choosing a compliant silicone products factory is of vital importance. As a professional silicone rubber products factory, we strictly follow FDA standards to ensure that every batch of products is safe and reliable. If you need FDA-certified medical silicone products, please feel free to contact us. We will provide you with high-standard customized solutions!