The FDA Approval Process
The FDA approval process is demanding and rigorous. Timely FDA approval is critical to your success and ARDL makes it easier on you. As an industry expert in materials and device testing, ARDL's services can help you minimize your risk.
Our in-house lab and services can provide you with technical support for
Investigational Device Exemption (IDE) Submissionsns.
FDA Detention/FDA Compliance Services
As an importer of latex/rubber medical devices, sooner or later you will be likely to experience US FDA Detention at Port of Entry.
When this occurs ARDL can help you by providing:
• On-Site Sampling by ARDL Personnel
• Training of Third Party Personnel to Sample
• FedEx of Test Data to FDA Compliance Officer
• Telephone & Fax Contact with FDA at Port of Entry to Resolve Problems
• Familiarity with Special Requirements of Specific FDA Branch Offices
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