FDA Re-Recognizes Three Radiology Consensus Standards

Posted 14 May 2014 | By Alexander Gaffney, RAC 

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards.

Background

Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.

The process, known as Incorporation by Reference, involves FDA formally recognizing those standards in the Federal Register, which it typically does several times each year. Sponsors of device applications can use those standards in several ways, which are outlined in the guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.

New Standards, Old Updates

On 14 May 2014, FDA released its 35th update to its list of recognized standards.

Unlike its 34rd update, which listed hundreds of changes and nearly two dozen additions, FDA's latest changes impact just three radiology standards:

Title of StandardChangeOld Recognition Number
IEC 60601-2-33 Edition 3.0 2010-03, Medical electrical equipment--Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Recognition restored with transition period 12-207
IEC 60601-2-22 Third edition 2007-05 Medical electrical equipment--Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment Recognition restored with transition period 12-208
IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment--Part 1-3: General requirements for basic safety and essential performance--Collateral standard: Radiation protection in diagnostic x ray equipmentRecognition restored with transition period 12-210

All three will again be recognized by FDA, the agency said.

All standards are available through FDA's searchable database, located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .


Federal Register Notice


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe