Good day Anon,
This can be a challenging area for administration and control of a company website - this was something I had struggled with personally when at companies as trying to control "free spirit" authors was difficult. In simple terms, and in most cases, a company website would be considered labelling by many regulatory agencies. Therefore, the content needs to be reviewed (and approved) just like any other labelling associated with the product such as direct labels or marketing brochures. You will not find any specific reference to a regulatory requirement, but it is common regulatory agencies will go on a company website reviewing information especially in advance of an inspection.
As any other quality system document, the company website should go through a change control process (document control) which includes having an identification and revision level of the website/page. What I found helpful in change management of a company website is there are a few pages which do not need be "controlled," so create a list of pages which do not require any review or approval. The website pages which would be managed through document control would be specifically related to the product or product information being conveyed. Another hint I found useful is conducting a periodic review of the entire company website (including any other social media platforms) by quality assurance or regulatory affairs to make sure no "magic pages" popped up - and yes it does happen. Doing a review once a year or every few months (depending on maturity of the website) against the information approved through document control ensures there are no surprises during an external review.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-May-2023 21:33
From: Kevin Randall
Subject: Company website - revision control requirements
Medical device website information about products is generally considered to be labeling. This is based on FDA's statutory definition of "labeling" (my paraphrase: all labels and other written, printed, or graphic matter accompanying the device). In HHS Publication FDA 89-4203, FDA says it interprets this liberally to mean, "more than physical association with the product", and that it includes, "information brought together with the device after shipment or delivery for shipment in interstate commerce". FDA's DICE has also confirmed to me that the agency views websites to be labeling. Accordingly, websites need to be subjected to the same developmental and change controls that would be applied to other medical device labeling. That may overlap with your Document Control process, but ultimately needs to be part of labeling design/change control. Some firms may only do this via the Document Control SOP and Device Master Record process (such as for devices exempt from design controls) or will instead, or in addition, do this via the design control mechanism.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 09-May-2023 02:06
From: Anonymous Member
Subject: Company website - revision control requirements
This message was posted by a user wishing to remain anonymous
Are there any revision control requirements for a medical device website?<o:p></o:p>
If yes, are there any specific references for these requirements?
Should we mention this in the Document Control SOP?<o:p></o:p>