Drug and Device Corner June 2022

The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or relabeled product will fail validation without the source NDC identified. The Source NDC is the code of the drug product being relabeled or repackaged. Currently, the unit of measure must match (source and relabel/repackage listing). As an example, for a bulk ingredient API shipped in drums and listed in kg, the corresponding relabeler / repacker NDC listing(s) [which may be much smaller] must also be listed in kg. The agency is working to update the validation procedure with a targeted date of fall 2022, where the system will accept the equitable conversion. If an update to an existing listing is required in the meantime, a manual override will be necessary. Contact Victoria Pankovich at EAS if you have questions on this requirement.

Are you ready for Class I and unclassified UDI compliance? The final compliance date for UDI requirements is for Class 1 and unclassified devices, provided these devices are not implantable, life-supporting, or life-sustaining. As of 24 September 2022, the FDA intends to begin enforcing the following requirements for these type of devices:

UDI Labeling, 21 CFR 801.20 & 801.50; Direct Mark, 21 CFR 801.45; GUDID Data Submission, 21 CFR 830.300; and Standard Date Format, 21 CFR 801.18.

Although the agency released a DRAFT guidance in October 2021, industry should be prepared to comply with the requirements by this September. EAS is available as your regulatory partner to assist you in understanding your specific obligations.

CDRH is taking steps toward normalcy. FDA has announced that, as of 1 June 2022, the agency plans to accept all non-COVID IVD pre-submissions. Note, it is likely these IVD pre-submissions will initially be reviewed under an extended timeline. Additionally, Federal Register /Vol. 87, No. 109 announced the withdrawal of the FDA guidance document titled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and Answers (Revised),” effective 7 July 2022.

Guidance Documents of Interest

Q9(R1) Quality Risk Management

The purpose of this document is to offer a systematic approach to quality risk management for better, more informed, and timely decisions. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment.

All Guidance Documents can be searched on the FDA’s website.

FDA Websites of Interest

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic