Electronic Nicotine Delivery Systems (ENDS)
FDA’s new Deeming Rule regulation, which deems vapor products as tobacco, will impact manufacturers of vapor devices, flavors, and e-cigarettes. Every component of the E-cigarette/ENDS must have a defined safety profile, the principles of operation defined, and an individual assessment of the functionality and interaction. Manufacturers are also required to report on the pattern of use for each e-cigarette device, including the consumer's average number of puffs, puff duration, puff intensity, and duration of use.
CSSi LifeSciences™ can guide your company through the maze of regulations and help you navigate the regulatory pathway. We have worked as a trusted partner and consultant for over 25 years with the US FDA, Europe, Competent Authorities, and health ministries, working with our clients to develop medical devices and pharmaceutical drugs. We are now leveraging our deep regulatory and clinical experience and knowledge in the vaping industry to help e-cigarette /ENDS and e-liquid manufactures and distributors navigate the new regulations.
Our staff have prepared and submitted hundreds of successful medical device and pharmaceutical drug regulatory documents, including:
- Product Testing, Validation and Hazard Risk Analysis
- Good Manufacturing Practices (GMP)
- Clinical and non-clinical studies
- US FDA Quality Management Systems
- Medical device 510(k) registration for Class 1, 2, 3, de novo
- Technical files/ design dossiers for CE Mark
- Audits and validation
- Rescue and remediation compliance services
Our experienced staff can see you through the FDA application and submission process in a timely and cost-effective manner, choosing the best possible pathway for your ENDS product.