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Medical Device Common Entry Errors

Introduction 

The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the medical device program.  Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. 

FDA defines a medical device as:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

  • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

To expedite entry screening of medical device products by the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, importers and entry filers must provide accurate product codes, all relevant affirmations of compliance (AofC) and accurate identifiers for firms, in addition to the general entry data. 

When applicable entry data is supplied electronically, completely and accurately, it can be used by the PREDICT system to “look-up” the information in FDA’s databases, validate the information, and issue a system May Proceed if the line is not held due to any other screening criteria.

When this additional entry information is not provided, or if it is provided incorrectly, the automated look-up will fail and the entry line may be subject to delays in processing.

The following chart shows the most common look-up errors for medical device entries during Fiscal Year 2017 (10/1/16 -> 3/31/17).

Medical Device Common Look-up failures pie chart

The table below provides additional information regarding these common errors to help you provide accurate and complete information to FDA.

Common Medical Device Look-up errors that result in a failed Look-up

Error

Description

Additional Information

LST not transmitted

No listing number (LST) was transmitted for the entry.

Verify that a listing number is required and provide one as applicable. There is no public website to search listing numbers because they are proprietary. Contact the listing entity to retrieve the number.

For more information see Who Must Register, List and Pay Fee

LST from Manufacturer or Device Foreign Exporter are acceptable.

Could not find LST number

The listing number transmitted could not be found in FDA's database.

Verify that the listing number provided is accurate and in the correct format.

For help on LST definition and format, see the Affirmation of Compliance Code guides.

For more information see Who Must Register, List and Pay Fee.

Rgstrn not trnsmttd(DEV/DFE)

No registration number was transmitted for the foreign manufacturer (DEV) or foreign device exporter (DFE).

Verify that a DEV, DDM or DFE is required and provide one as applicable.

 

For more information see Who Must Register, List and Pay Fee

To search for registration information see the Search Registration and Listing Database

For US goods returned, Import for Export (IFE), reprocessing, and medical device kits, a domestic device manufacturer (DDM) may be required if DEV/DFE is not applicable.

Mnfctr has Country code = US

The listing number transmitted indicated that the manufacturer was a US firm but the manufacturer provided on the line is a foreign firm.

Verify the correct LST was provided.

 

Product Code does not match

The product code transmitted for the entry did not match the product code on file for the listing number transmitted.

Verify that the correct LST was provided and/or that the product code matches the LST.

To help determine the appropriate product code, visit the Product Classification searchable database webpage. 

For additional assistance with building a product code visit FDA’s Product code builder webpage.

Submission # does not match

The Pre-market notification or Premarket approval (PM#) transmitted for the entry did not match one of the numbers on file for the listing number transmitted.

Verify that the PM# provided matches the product being introduced for import.

Some medical devices require premarket submissions depending on use and classification.  For additional information visit the Medical Device Overview webpage. 

To search for premarket submissions, visit the Medical Devices Databases webpage.

Firm name does not match

The firm name provided in the entry did not match the firm name on file for the listing number transmitted.

Verify that the firm listed on the entry matches the firm used for the LST.

When supplying manufacturer information through the Automated Commercial Environment (ACE), you are only required to submit a firm name and address; however, if a FEI number is also provided, that can improve the chances that firm name matches the registration number provided.

To find the FEI for a registered firm, search the firm’s registration number on the Search Registration and Listing Database; the FEI is located in the registration record.

Registration does not match

The registration number provided in the entry did not match the registration number on file for the transmitted listing number.

Verify the DEV provided matches the LST provided.

 

UNK is declared as IUC and the AofC REG supplied instead of DEV

When the IUC is declared as UNK, inappropriate AofC qualifiers can be transmitted causing a lookup failure.

Example: The Affirmation of Compliance (AofC) provided was for Drug Registration (REG) not Device Manufacturer Registration (DEV) or Device Foreign Exporter Registration (DFE) as required for a device entry.

Make sure when submitting a foreign device registration number that either DEV (manufacturer) or DFE (exporter) is used.