Authors: Gary Saner, Sr Manager Information Solutions & David Wilson, Sr Acct Exec
What are the required actions when a product includes both a medical device constituent and a drug constituent?
In this scenario, the combination product was reviewed by CDRH and cleared under a 510(k). The combo product is identified with both a NDC/NHRIC identifier and a UDI identifier on the label. Additionally, the combo product is listed as a ‘medical device’ on the FDA/NLM DailyMed and reported as a medical device on the FDA/CDRH/NLM AccessGUDID database.
ITEMS TO CONSIDER
- Controls – If the Combination Product was cleared under a 510(k), it only needs to comply with medical device regulations pending the details in the FDA product clearance letter. Always revisit the details of the FDA clearance to check for any additional ‘drug-related’ controls.
- DailyMed Listing – The medical device Combo Product does not need to be listed in NLM DailyMed. However, note that the drug constituent does need to be independently listed in DailyMed. Medical devices may be voluntarily included in drug kits, but such inclusion is not encouraged.
- DailyMed Actions – The FDA may ask the manufacturer to delist the Combo Product from the NLM DailyMed by submitting an SPL update with a Market End Date. Optionally, the FDA may manually remove the Combo Product from the DailyMed without an SPL update.
- NDC/NHRIC Identifiers – FDA CDRH is rescinding NDC/NHRIC identifiers from medical devices. The medical device UDI regulation defines end dates for placing legacy NDC/NHRIC identifiers on medical device labels based on UDI Compliance Dates.
- Supporting Material – To further support the position that the Combination Product is considered/regulated as a medical device, consider providing links to a few representative product records currently published on the NLM AccessGUDID website. This CDRH related database includes medical device identifiers and attributes and demonstrates reporting of this product as a medical device.
- UDI & Combination Products — The medical device constituent does not need to have a separate UDI if the Combo Product assembly has a UDI (the medical device constituent is covered by the Combo Product assembly UDI). Medical Device Constituent ID in Combo Product
- What to know about discontinuation of legacy FDA identification numbers assigned to devices. On the date your device is required to carry a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package.
Since the UDI regulation was released in 2013, FDA issued Guidance in 2016 that defines enforcement discretion of the prohibition of NDC/NHRIC identifiers on medical device labels until Sep 24, 2021.
Where to get experienced UDI solutions and services: At Reed Tech, we specialize in understanding the key aspects of medical device regulations both in the U.S. and around the globe. Contact us for help with medical device product management and regulatory data submissions. Email us: MedDevice@ReedTech.com or call 215-682-8269
For more information regarding Combination Products, see:
Combination Product Definition and Combination Product Types 21 CFR 3.2(e)
Discontinuation of legacy FDA identification numbers assigned to devices §801.57 eCFR Section 801.57
General exceptions from the requirement for the label of a device to bear a unique device identifier. 801.30(b)
NLM-National Library of Medicine/FDA
DailyMed-NIH/National Library of Medicine/FDA