FDA clearance depends on a wide range of test data demonstrating product safety and performance—and in recent years, the FDA has sharpened its scrutiny of data integrity and testing laboratory adequacy. In particular, the FDA has increasingly raised data-acceptance concerns about data generated in certain countries or by certain laboratories.
Grounded in FDA regulatory requirements and real review cases, LK Consulting helps you build a testing strategy suited to your product—and connects you with laboratories you can trust.

Today, the FDA examines not just test results but the full picture: the adequacy of the testing laboratory, how testing was conducted, data integrity, and end-to-end traceability of test data. With data-acceptance rejections now occurring for data from certain laboratories, getting your testing strategy and laboratory selection right early has never mattered more.
Combining real FDA review experience with a global network of testing laboratories, LK Consulting designs testing strategies suited to your product and its regulatory requirements. Through partnerships with ASCA-accredited laboratories and trusted labs at home and abroad, we deliver practical testing support with FDA acceptability built in from the start.