On August 25, 2020，Firstunion Group has completed the first round review of the PMTA application and received an acceptance letter from the US Food and Drug Administration (FDA). This notification moves the Firstunion submission to the substantive review phase of the PMTA procedure.
Firstunion has always put the safety as priority during the ID design, manufacturing, and quality testing. When applying for PMTA, in order to achieve overall health improvement, we need to prepare three aspects. The first is consumer safety, which is for E-cigarette users. The second part is public safety, which is for all people. The third part is high-quality manufacturing, which is necessary to prove to the FDA that it can continue to produce products with the same quality. The entire application process requires a huge investment of capital, manpower, and material resources, not just based on the consideration of entering the US market. More importantly, we hope our global consumers to experience more safety products.
What has Firstunion done for the PMTA?
Receiving the acceptance letter from FDA represents an important step for Firstunion in the PMTA process, because our vapor products, as an alternative to combustible cigarettes, will be initially supported by the FDA under high-quality requirements.
Before entering the substantive review stage, after more than one year of hard work, we completed more than 100,000 pages of application material evidence to support our claims. Multi-faceted testing data and reports proved that our products are suitable for protecting public health. We look forward to continuing to work with the FDA in the coming weeks and months and remain optimistic that the PMTA process will bring orders.
Firstunion has 16 years of ODM/OEM experience with international customers, excellent manufacturing capabilities and R&D advantages are the fundamental elements to the PMTA application. Firstunion SRA team is currently undertaking 7 projects of PMTA application for our ODM/OEM customers around the world.
Firstunion Laboratory has been certified by UL and NEMKO WTDP and other authoritative organizations, the test results are mutually recognized by these organizations. The time and cycle of customer certification requirements can be extremely shortened, which have a huge competitive advantage than other company. During document submissions, which steps of preparing documents should be formulated by the chief scientific compliance officer of Firstunion and assigned tasks by a strict project management process. We strive to ensure that our customers’ products continue to be in the market and continue to be sold.
What can we do for your vaping brands?
Scientific & Regulatory Affair ( SRA) of Firstunion
Firstunion has been engaged in Vape industry for many years, and the international professional compliance team provides customers with one-stop PMTA service. Including project management, program design, testing and research, scientific writing, review and release of all-round services, a great deal of manpower and material resources are saved meanwhile can save application costs. To support customers achieve long-term development in the international market.
We believe that under the new regulations, a fair and honest PMTA procedure will be adopted to establish a higher standard for the Vape industry, meanwhile which is the needs of development for Vape industry. By assisting customers with PMTA application services, it helps Firstunion maintain close communication with customers.
