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Compliance In Focus
Posted by Brandy Chittester on Mon, Mar 11, 2013

FDA Wants Standardized Terminology for Medical Devices

Just released on FDA’s website concerning The Center for Devices and Radiological Health (CDRH)FDA Wants Standardized Terminology for Medical Devices is a posting that reads “Data Standards and Terminology Standards for Information Submitted to CDRH” which is intended to benefit device manufacturers, hospitals, and clinical investigators. But what exactly are the benefits to data and terminology standards?

First, it’s important to understand the terms “Data Standards” and Terminology Standards.” According to FDA’s website:

  • Data Standards provide consistent meaning to data shared among different information systems, programs and agencies throughout the product’s life cycle. These include representation, format, definition, structuring, tagging, transmission, manipulation, use, and management of data.
  • Terminology Standards control terms and definitions used in submissions to the FDA. They are often used in combination with a data standard to aid in exchange and interpretation of data.

Last year FDA released a Guidance for Industry titled, “Providing Regulatory Submissions in Electronic Format — Standardized Study Data.” This guidance expresses the FDA’s recommendation that sponsors submit clinical and nonclinical data in a standard electronic format. In the guidance the FDA points out that standardizing study data makes the data more useful. “Data that are standardized are easier to understand, analyze, review, and synthesize in an integrated manner in a single study or multiple studies, thereby enabling more effective regulatory decisions.”  The faster FDA can review and analyze data, the less hold up on pre- and post-market submissions.

Perhaps the most interesting words FDA defines on the release are listed under the terminology standards which include:

  • Event Problem Codes
    • Adverse Events - Used by device manufacturers and user facilities for describing adverse events and product problems in medical device reports (MDRs), as well as alternative summary medical device reports (ASR).
    • Recalls and Corrections - In the future, these terminology sets will also be available for submitters of voluntary reports of corrections and removals (recalls) and voluntary complaints to describe issues involving a device.

Also included are the terms that FDA defines under Data Standards:

What are your thoughts on FDA’s request for standardized terminology? Do you think it’s going to result in faster review times? Let us know what you think and comment below.

Photo Credit: larry wfu

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Topics: Standardized Terminology, FDA, CDRH


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