{{ phone }} {{ location }}

Emergo by UL logo

     

New Manufacturer Evaluation Codes in Place at FDA

|

New Manufacturer Evaluation Codes for use in medical device reports have been established by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

Developed by the CDRH in collaboration with the National Cancer Institute Enterprise Vocabulary Service, the new codes update those used in Section H6 of FDA Form 3500A, and pertain to evaluation methods, results and conclusions of device evaluations.

The US regulator saw updated codes as necessary because most existing manufacturing codes did not allow for detailed evaluation explanations, and provided now change control procedures for modification of terms. Furthermore, the previous coding system provided no online access to enable users to download current terms.

The previous coding system had undergone no systematic review since its implementation, and provided no quality improvement capabilities.

The new codes are available for download in Excel, XML and text formats. Older codes can still be used in electronic medical device reports for the time being, but CDRH intends to phase out their use over the course of a year. (The agency will notify industry when a firm deadline has been decided.)

Related News

CDRH Sets Up Pilot Program on Establishing Panel of Outside Experts

CDRH Issues Additional Import Entry Review Process Recommendations

Questions? Request more information from our specialists

CONTACT US >