CSMS# 17-000071 - FDA Requirements Change for Medical Devices, IUC 081.005
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FDA Requirements Change for Medical Devices, IUC 081.005
The requirements for transmitting medical device constituent parts for drug-device IND combination products, Intended Use Code 081.005 have been changed.
The following Affirmations of Compliance for IUC 081.005 are now conditional: DEV, DFE, LST. These Affirmations of Compliance are in addition to DA and IND, which are already indicated as conditional. This change will be reflected in the next version of FDA’s Supplemental Guide
Please contact FDA ACE Support with any questions.
ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320
FDA Requirements Change for Medical Devices, IUC 081.005
The requirements for transmitting medical device constituent parts for drug-device IND combination products, Intended Use Code 081.005 have been changed.
The following Affirmations of Compliance for IUC 081.005 are now conditional: DEV, DFE, LST. These Affirmations of Compliance are in addition to DA and IND, which are already indicated as conditional. This change will be reflected in the next version of FDA’s Supplemental Guide
Please contact FDA ACE Support with any questions.
ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320
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