CHALLENGE:
A new US based division manufacturer of a Chinese dental implant, wanted to grow their business by bringing their product, material used in the construction of dental implants, to the US market. With no prior experience in US medical device regulations, they needed assistance determining the best regulatory path and guidance to navigate the process efficiently.
APPROACH:
AlvaMed worked with the client to determine that the material was considered a device and would require a 510(k) submission. AlvaMed determined an applicable predicate and the required testing and applicable standards. The client then executed the required testing. Once the testing was completed AlvaMed worked with the client to compile and submit the 510(k). AlvaMed also assisted in responding to the interactive questions from the FDA regarding the submission.
During the project AlvaMed provided the following regulatory support:
- Regulatory Strategy: Developed a detailed regulatory strategy to ensure compliance and streamline the 510(k) submission process.
- Predicate Research and Selection: Conducted thorough research to identify and select the most appropriate predicate device.
- Research and Writing of 510(k): Compiled and authored the 510(k) submission, ensuring all necessary data and documentation were included.
- 510(k) eStar Submission: Facilitated the electronic submission of the 510(k) application using the FDA’s eStar system.
- FDA Interaction: Managed and resolved interactive questions from the FDA, ensuring a smooth and efficient review process.
RESULTS:
The FDA targets 90 days for 510(k) review and clearance. The client however, achieved FDA clearance in under 60 days, significantly accelerating market launch. AlvaMed was able to provide the client guidance so that the interactive questions received from the FDA were answered sufficiently and completely.
IMPACT:
AlvaMed’s regulatory expertise empowered the client to achieve a successful US market entry with faster market access, reduced regulatory risk and streamlined communications with the FDA.
KEY TAKEAWAYS:
This case study highlights the importance of partnering with a regulatory expert for a smooth US market entry:
- Understanding Regulatory Landscape: New entrants benefit significantly from guidance in navigating complex US medical device regulations.
- Faster Clearances: Experienced regulatory consultants can help achieve faster FDA clearances through efficient submission preparation.
