It is now mandated that select data elements be submitted into ACE at the time of entry for FDA-regulated articles to include foods, human and animal drugs, medical devices, biological products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), radiation-emitting electronic products, cosmetics, and tobacco products.
- Much of the new rule is codifying the way things are today. But it also shows the interplay between the FDA, who many would say did a ‘data grab’ with FDA message set, and the trade. And, it clarifies the changes from the old process and the new. Many are pretty exciting for us that have been battling/frustrated with the FDA for many, many years.
- The fact that FDA is moving to a risk-based system is something the trade has been clamoring for over many years. And to let the system make the determination in the majority of instances vs an FDA employee speeds things up greatly.
- The average time for an FDA-reviewer to manually review and issue a “May Proceed” determination in ACS from August 27 to October 22, 2015, was about 28 hours and that has been reduced to under 2 hours in ACE
- FDA rejected comments that it should make Device Listing Numbers (LSTs) publicly available, and decline to make the requested revisions to the requirement to submit the LST (i.e., permit the use of “UNK” instead of the LST). This is problematic because importers often do not have access to this information at the time of entry. But it appears that FDA erred on the side of keeping LSTS confidential: “The confidentiality of LSTs serves important public health interests and helps to prevent the importation of substandard, mislabeled, and counterfeit medical devices.”
- It’s quite surprising that no one commented on radiation emitting devices. I would have also requested that the registration information be made available to the public, but FDA probably would have used the same argument as they did with LSTs.
- FDA has revised § 1.90 to allow FDA to provide notice of sampling directly rather than through the “collector of customs” which will normally happen through a secure electronic system. No more waiting for your detention notice to show up in the mail! Very nice.