FDA compliance is essential to bringing your products to market. Pace’s high-level consultants combine expertise and industry knowledge to guide you through these regulations. We offer understanding of the regulatory challenges you face and provide the information you need to make informed decisions.

Medical Devices

Prior to market sale, medical devices must be reviewed and approved by the Food and Drug Administration (FDA) in the United States. Based on the device’s classification, the correct regulatory requirements and submission application must be completed in order to receive approval. Allow Pace’s FDA consultants to guide you as you bring your device to market:

  • Classification determination
  • 510(k) preparation and submission
  • Premarket Approval (PMA) preparation and submission
  • Investigational Device Exemption (IDE) and other exemptions

Contact me to learn more!

 
April Long
April Long | Sales Manager, Regulatory Services