Did You Know… Pad & Liner Education

Did You Know… Pad & Liner Education

 

1. Carefree Pads & Liners are Regulated by the FDA

Our pads and liners are regulated by the U.S. Food and Drug Administration (FDA) through its Center for Devices and Radiological Health (CDRH). This agency ensures that medical devices like Carefree Pads & Liners are safe, effective, and high quality.

 

2. Pads and Liners are Classified as Class I Medical Devices

Pads and liners are usually Class I medical devices and must meet FDA rules:

      • Safety and performance testing: to ensure they work well and are safe to use
      • Manufacturer registration: companies must register with the FDA, so they know who makes the product
      • Product listing: each product must be listed with the FDA so it can be tracked

💬 Did you know? Other Class I devices include adhesive bandages and manual toothbrushes.

 

3. Manufacturing and FDA Oversight

Carefree manufacturing facilities follow strict quality and safety standards. The FDA can inspect them at any time to ensure we comply with:

      • FDA’s Quality System Regulations: covering everything from design to production to packaging
      • International standards like ISO 13485:2016: a global benchmark for medical device quality management

We also monitor our products after they’re on the market to ensure they continue to meet safety, quality, and performance expectations.

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