Rashmi,
When there is an new or updated standard, guidance document, or regulation, the expectation is that the organisation has reviewed the new or updated regulatory requirement against what currently exists in your quality system. This is also a requirement in ISO 13485 that regulatory requirements are reviewed as part of management review. FDA knows this as well. So as an example, if a sterilisation standard like ISO 11135 was revised, and the company sold sterile product, the expectation would be to review the new requirements against what currently exists to either have a Letter to File that there is no impact or up to a re-validation or new validation.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 23-Apr-2018 22:38
From: Rashmi Pillay
Subject: Compliance to updated standards
Hi,
Is there a requirement to have a Letter to File on records for FDA , whenever there is an update to the standards.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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