#11: When possible, the technological characteristics of your product must be designed to optimize the FDA “Substantial Equivalence” definition to support a 501(k) application.

#12: Software is becoming an important element of every medical device. Do not forget to discuss the Level of Concern of your software and related validation and 510k documentation requirements very early in the design process.

#13: Under CLIA, laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.

#14: FDA registration fees need to be paid annually, for a September-to-September period. Foreign Small Businesses can apply for an FDA’s Small Business Certification that yields to significant (50% to 70%) “Discounts” for user fees (e.g. 510Kk) fees

#15: FDA “agents” should not be confused with “commercial agents” or Custom/export brokers. An FDA Agent is an operational liaison to FDA and can be appointed in the U.S. or retained as part of dedicated services providers for $50 to $150 per month.