Jordi Labs is an authority on regulatory testing and compliance-based analytical services for a range of markets worldwide. We can help research and development (R&D) teams to meet strict national and international specifications at every stage of the production chain, from early toxicological risk assessments to complex regulatory applications. These objectives are critical for ensuring the safety and efficacy of products that may impact public health, from food contact materials to pharmaceuticals.
The U.S. Food and Drug Administration (FDA) is largely responsible for regulating the standards of drugs, food goods, and medical devices available on U.S. markets. Though compliance-based testing can often be conducted on a basis of substantial equivalence, many regulators have defined standards that specific products or testing methodologies must adhere to. At Jordi Labs, we are familiar with FDA regulatory testing specifications and can carry out standard-based analyses for a range of industries and objectives. These include:
- Extractables and leachables (E&L) testing
- Toxicological risk assessments
- Premarket notifications; 510(k)
- Premarket approvals (PMA)
- New drug applications (NDA)
We can carry out routine FDA-approved regulatory testing of paper materials intended for contact with aqueous and fatty foods according to FDA 176.170. Our chemists are also familiar with styrene block analyses by FDA method 177.1810. Browse the table below for more examples of the FDA regulatory testing specifications that we regularly adhere to, or contact a member of the Jordi Labs team today to see how we can meet your FDA compliance needs.
| Standard | Category | Description |
|---|---|---|
| FDA 176.170 | FDA | Components of paper and paperboard in contact with aqueous and fatty foods |
| FDA 177.1810 | FDA | Styrene block polymers |
| FDA 177.1380 | FDA | Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces |