The US FDA Regulatory Calculator

Accelerate the Research and Assessment Phase of Your Medical Device Technology
Classification and regulatory pathway information from our partner e-Zassi
Click here to see a sample report
Click here for a summary of how the calculator works
Price: $500 $375 special introductory offer!

Please note: You will be taken to the e-Zassi website to complete your order.

Understanding the classification and regulatory pathway of new medical device technologies is crucial to early business planning, market assessment, and understanding of FDA requirements. Failure to accurately identify FDA classifications early on can cost you millions in terms of development money and dramatically alter revenue expectations. But having a clear understanding of over 5,300 FDA product codes is not easy. Typically, this takes in-house staff or outside consultants many research hours, can delay product development, and eats up additional time and money. Now there is a better way… a much faster and cheaper way.

Within minutes, the US FDA Regulatory Calculator provides users with a potential FDA predicate, regulation product code, and the classification and regulatory pathway associated with a medical technology. With this new tool, you’ll save hours in initial research and eliminate the need for outside experts early in the process. You can immediately review and save your results, and e-mail your output to colleagues for review.

Click HERE to see a sample report

Click here for a summary of how the calculator works

Accelerate the Research and Assessment Phase
of Your Medical Device Technology

Having classification and regulatory pathway information at your fingertips early in the device development process will minimize the potential for miscalculations with due diligence, technology assessment, planning, and commercialization. You’ll know exactly where you stand on the regulatory front - a critical factor as you develop your clinical trial strategy to support your FDA submission and eventual product launch. The US FDA Regulatory Calculator will also deliver:

  • Powerful regulatory expertise at your fingertips to help you navigate the rapidly evolving medical device regulatory landscape
  • Cost savings by empowering you to conduct advanced regulatory calculations in real-time, directly from your PC
  • Time savings and reduced guesswork by eliminating the need to sift through more than 5,300 FDA product codes
  • An immediate understanding of the classification and regulatory pathway for your device

As researchers and TTOs attempt to license medical device technology or pitch R&D plans to potential funding sources for commercialization, the US FDA Regulatory Calculator offers a powerful yet inexpensive tool to enhance and speed your preparation. For IP attorneys, the US FDA Regulatory Calculator will help you assess the opportunity and regulatory burden of a technology, and help clients develop their commercialization strategy.

In addition, all companies and organizations involved with early-stage medical device technology will find the US FDA Regulatory Calculator a MUST-HAVE for FDA meeting preparation. By having this valuable information available beforehand, you’ll have a firm understanding during your discussions with the FDA of specific product codes and assigned predicates being considered.

The US FDA Regulatory Calculator is Now Available With Introductory Pricing - You Save $125!

  1. To order the US FDA Regulator Calculator and lock in the $125 introductory discount, click here to proceed to the e-Zassi order page.
  2. Complete brief registration and payment form.
  3. Upon signing in, you will immediately be able to run three medical technologies through the calculator. You can easily extend your usage for additional devices at the same low rates. Don’t miss out on this special offer!

Plus, a FREE year of membership in the e-Zassi medical device expert network

With this introductory offer, you’ll also get a valuable free bonus that you’ll benefit from for an entire year: A 12-month membership to the e-Zassi medical device online network. Belonging to this unique, focused network of medical device experts allows you to tap into expertise and find business contacts in a powerful, unprecedented way - and you become “searchable” as well, bringing you and your organization valuable leads, contacts, and opportunities.

Members enter key information on their background, expertise, and interests. By querying the database using specific search criteria, you can instantly find potential partners, licensees, subject matter experts, vendors, and colleagues who match your specific needs. And the network’s Auto-Match feature will even recommend synergistic matches within the network. This powerful additional tool is yours free, for a full year, with your purchase of the US FDA Regulatory Calculator.

About the Publisher
2Market Information, publisher of Technology Transfer Tactics, is proud to partner with e-Zassi in bringing this critical tool to our customers. e-Zassi is the medical device industry’s first subscription-based, integrated online business network, decision support software and technology marketplace. Launched in 2008, the company was spun out from Zassi Medical Evolutions. e-Zassi is dedicated to transforming the way medical device companies, technology transfer organizations, innovators, researchers, service providers, government agencies and investors connect and collaborate, generating powerful new efficiencies in the development and commercialization of life-saving medical technologies.

Our Guarantee of Quality and Value
Your satisfaction is completely assured with our NO QUESTIONS ASKED MONEY BACK GUARANTEE. If you are not satisfied with your purchase, simply notify us and we’ll send you a complete and immediate refund — it’s that simple!


Please note: You will be taken to the e-Zassi website to complete your order.



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