Frequently Asked Questions

What types of clients does LDT Regulatory Solutions work with?

At LDT Regulatory Solutions, we work with clients of all sizes, from small startups to large laboratories.

Will FDA's new requirements for LDTs be too expensive and burdensome for our smaller lab to adopt?

While there will be initial costs for any lab to establish compliance and complete necessary device registrations, compliance itself will allow your services to be marketed to a much wider audience. As an example, pharmaceutical companies have been limited in their ability to use LDTs commercially for companion diagnostics for many drug products due to use of LDTs being limited to the development lab location. In the future, labs will be able to reach more patients than ever before as pharmaceutical companies will now be able to use their FDA-registered devices. Furthermore, if an LDT lab's revenue is under $100M per year, the FDA provides a significant discount on medical device registration costs.

Additionally, LDT Regulatory Solutions has flexible pricing and support to meet the budget and compliance needs for labs of all sizes.

Why should I choose LDT Regulatory Solutions and not a large regulatory or legal consulting firm?

Large regulatory and legal firms have higher overhead, which is built into their charges billed to the client. Oftentimes, large firms do not have specialized internal personnel to meet a specific client need and they must hire external resources to meet that need -- often those resources they hire are us. When you hire LDT Regulatory Solutions, you are going directly to the consulting resource, thereby saving money while not sacrificing quality of services.

There are so many phases and requirements - where do we start?

We know what to do! We will guide you through all the phases, providing you with a roadmap through each phase and performing compliance activites appropriate to each step of FDA's Phaseout Policy. In the process, we will help educate you and help you make appropriate business decisions regarding your LDT products. We can articulate which regulatory decisions impact your business and can explain your options in the context of the regulatory requirements. For example, you may want to register all of your tests, register only your "money makers", or you may want to sell some of your tests to other companies. We will help you look at the long-term regulatory strategy for your business and guide you based on the regulatory requirements for a given product or group of products.