FDA Strikes Certain Data Requirements for Imported Products in Final Rule

Taking into account industry criticism, the FDA has loosened the data requirements that manufacturers of combination products will have to meet to determine the admissibility of imports entering the U.S.

For combination products consisting of at least one medical device and one investigational new drug, the final rule removes the requirement to submit the investigational new drug application number.

In a little more than a decade, the volume of FDA-regulated imports entering the country rose from 6 million to 35 million, said Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy. — Jeff Kinney