The difference between FDA compliant and FDA approved is that FDA compliant means that a product has met and meets FDA guidelines.
FDA approved means that the products have undergone rigorous testing and evaluation by the FDA.
FDA compliant are products that meet FDA regulations for safety, packaging and labeling.
FDA compliant products may pass inspections and have the proper forms submitted to the FDA.
Manufacturing processes and facilities may also be FDA compliant.
And to be FDA compliant companies must also follow current good manufacturing practices.
FDA approved products have been tested for safety and efficacy by the FDA.
FDA approved means the FDA has determined that the product's benefits outweigh it's known risks.
And manufacturers must also submit a premarket approval application and clinical testing results.
The FDA may also approve a product or products even when they have a higher risk if the potential benefits are significant.
The FDA approval process for medical devices and drugs includes several steps which include discovery, preclinical research, clinical research and post market safety monitoring.