Jan 17, 2013

The US Food and Drug Administration (FDA) has announced changes to the list of recognized standards the agency uses in the medical device regulatory process.

Manufacturers should familiarize themselves with the revised FDA list in order to issue accurate Declarations of Conformity and ensure compliance with these standards as part of their US medical device registration efforts.

Areas in which more up-to-date standards have replaced previous versions include:

Biocompatibility Materials
Cardiovascular OB-GYN/Gastroenterology
Dental/ENT Ophthalmic
General Orthopedics
General Hospital/General Plastic Surgery Sterility
In Vitro Diagnostics  

New entries to the FDA’s list of standards have also been added in the following areas:

Cardiovascular OB-GYN/Gastroenterology
Dental/ENT Ophthalmic
General Orthopedic
General Hospital/General Plastic Surgery Radiology
In Vitro Diagnostics Software/Informatics
Materials Sterility

Of particular interest to medical device manufacturers whose products incorporate software components are four new entries added under the Software/Informatics section. These entries cover validation of software for regulated processes (AAMI TIR362007), guidance on applying ISO 14971 to medical device software (IEC/TR 80002-1 Edition 1.0 2009-09), applying quality management system concepts to medical device data systems (ANSI/AAMI SW87 2012), and guidance on applying AGILE practices to medical device software development (AAMI TIR45 2012).

As software and related technologies become more and more common elements of medical devices, manufacturers must now ensure compliance with standards previously applied at more “conventional” products.


  • Stewart Eisenhart