FDA Plans to Use ISO 13485 for Medical Devices Regulation

Intended to harmonize domestic and international requirements

(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.

The International Organization for Standardization’s (ISO) international standard, ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes, is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

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ISO 13485 -third revision.

Hello,

I have a question for (and may be a request to) the committee TC 210.

Why has this standard not been harmonised to the HLS-high level structure-adopted by the ISO for all its standards.

I would request that this be promptly done so that the medical devices manufacturers can also get advantages of requirements like context, risk based thinking and many other new characteristics of the HLS.

regards

virendra gupta

Good to hear

It is great to hear that FDA is using regulatory standards like ISO 13485 for Medical Devices Regulation taking health care standards into consideration, For FDA software validation process one must update their systems for this regulation to be up to date