Newly Required FDA Cosmetic, Food and Medical Device Data Elements in ACE

Shapiro is fully programmed for all FDA filings and has been actively filing FDA though ACE for many months.   Under the ACE platform FDA is requiring additional, and in many cases new information, to be submitted in import entries.  Specifically all entries for FDA Food, Cosmetics and Medical Devices are affected.

Below is a list and brief description of the new required elements.  Our goal is to assure all of our customers are as prepared as possible, and that there are no delays in facilitating the release of their products.  If you have any questions about these new requirements please reach out to your Shapiro Import Analyst for further information.

FDA Cosmetics

  • Manufacturer DUNS number
  • Delivery Party: S. party that physically receives the goods.

FDA Food Products

  • Manufacturer DUNS number
  • Delivery Party: S. party that physically receives the goods.
  • Temperature Information for the goods
  • Lot Number
  • Agency Processing Codes:
NSF:     Natural State Food
PRO:    Processed Food
FEE:     Animal Food (includes pet food, medicated feed, feeds
ADD:   Additives and Colors
DSU:    Dietary Supplements

 

  • Intended Use Code: Possible codes shown in the table below depending on Agency Processing Code.

 

INTENDED USE CODES 

Food with Prior Notice (All Agency Process except *CCW)

*Ceramic Ware and other food contact substances

*CFSAN Regulated Products Intended Use Code Intended Use Name

 

For research use as Human Food

260.000 For research use as Human Food

 

For research use as an Animal Food

015.000 For research use as an Animal Food

 

Personal Importation

210.000 For personal use as Human Food
*Center for Food Safety & Applied Nutrition

INTENDED USE CODES

Food No Prior Notice (Agency Process = *CCW)

*Ceramic Ware and other food contact substances

*CFSAN Regulated Products Intended Use Code Intended Use Name

 

For research use as Human Food

260.000 For research use as Human Food

 

For research use as an Animal Food

015.000 For research use as an Animal Food

 

Personal Importation

210.000 For personal use as Human Food
*Center for Food Safety & Applied Nutrition

 

FDA Medical Devices

  • Trade Name of Device
  • Manufacturer DUNS number
  • Delivery Party: S. party that physically receives the goods.
  • Affirmation of Compliance Codes:
  • DFE (Device Foreign Exporter)
  • DEV (Device Registration Number)
  • LST (Device Listing Number), others vary depending on type of device
  • Intended Use Code: Possible codes shown in the table below.

 

Intended Use Definition Intended Use Code Relevant Medical Device Import Scenarios
For Human Medical Use as a Medical Device 081.001

Standard import of a medical device, accessories, or components regulated as a finished device

Import of refurbished device

Import of a reprocessed device

For Human Medical Use as a Medical Device for Domestic Refurbishing 081.002 N/A
For Human Medical Use as Medical Device–domestically manufactured device that is part of a medical device convenience kit. 081.003 N/A
For Human Medical Use as a Medical Device –foreign manufactured device that is part of a medical device convenience kit 081.004 N/A
Importation of a device constituent part (finished device) for use in a medical product regulated under a drug (CDER) application type (e.g., for use in an NDA/ANDA/BLA drug-device combination product). 081.005 N/A
Import of a medical device under enforcement discretion provisions per final guidance: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf 081.006

Applicable product codes for CBP business rule:

80O – – UG; 86N – – FF

86N – – FG; 80N – – XQ

90L – – MB; 90L – – MD

For Personal Use as a Non-Food Product – for personal use as a medical device 100.000 N/A
For Public Exhibition or Display as a Non-Food Product 110.000

Includes import of device for trade show

 

For Charitable Organization Use as a Non-Food Product 140.000 N/A
Component for further manufacturing into a finished medical device 081.007 N/A
Importation of a device component for use in a medical product regulated under a drug (CDER) application type (e.g., for use in an NDA/ 081.008 N/A
For Repair of a Non-Food Product 170.000 Repair of medical device and re-exportation
For Research and Development as a Non-Food Product – For research and development as a medical device 180.010 Import of research or investigational use in vitro diagnostic device
For Research and Development as a Non-Food Product – for bench testing or nonclinical research use 180.014

Import of a device for non-clinical use/bench testing

Import of device sample for customer evaluation

For Research and Development as a Non-Food Product – import of a medical device for clinical investigational use 180.015 N/A
Import of a device that is US goods returned for refund/overstock (to manufacturer) 920.001

Refund/overstock

Bench Testing

Corrective Action Prevention Action (CAPA) Plan Investigation

Recall

Import of a device that is US goods returned for sale to a third party 920.002 N/A
Import of a Compassionate Use/Emergency Use Device 940.000 N/A
Import of a single-use device for domestic reprocessing 950.001 N/A
Import of a multi-use device for domestic reprocessing 950.002 N/A
Import for Export 970.000

Import of a medical device for further processing and re-exportation

Import of medical device or accessory for further manufacturing into an export only medical device

Import for Export 970.001 Import of a medical device component for further manufacturing into an export only medical device