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Dear covers,
I have a dilema regarding the applicable controls over the content of a product website.
Reading the FDA Guidance on "Labeling", published in August 1989 (text quoted below in italics), and the "Device Labeling" website from the FDA "Device Advice" site, I understand that the website content related to a product falls under the definition of labeling, in the same way that their paper equivalents (brochures, posters, etc.) do.
If the assumption is correct, 21 CFR 801 and 820 are applicable to them and the content needs to be reviewed and therefore the Device History Record (DHR) updated with the reviewer and the date of the review. It seems to me a little unpractical to update the DHR when the product website is updated (although I understand the reasons for it). How do other people deal with this issue?
As an additional note, probably irrelevant to this post, We "manufacture" standalone software that is classified as a class II medical device.
Thank you in advance for your response,
esalsan
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Section 201 of the FD&C Act distinguishes between label and labeling. Certain provisions in Chapter V of the FD&C Act apply specifically to the "label" of the device, others are related to its "labeling." These terms are related, but not interchangeable. Of the two, the term "label" is more restricted. Generally, it consists of that art of the display confined to the device itself. On the other hand, "labeling" deals wit the label on the device, and descriptive and informational literature that accompanies the device.
Section 201 (k) defines "label" as a:
* "display of written, printed, or graphic matter upon the immediate container of any article.. . "
The term "immediate container" does not include package liners. Any word, statement, or other information appearing on the immediate contamer must also appear "on the outside container or wrapper, lf any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."
Section 20 1 (m) defines "labeling" as:
* "all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanyin such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
The term "accompanying" is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. "Accompanying" also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
I have a dilema regarding the applicable controls over the content of a product website.
Reading the FDA Guidance on "Labeling", published in August 1989 (text quoted below in italics), and the "Device Labeling" website from the FDA "Device Advice" site, I understand that the website content related to a product falls under the definition of labeling, in the same way that their paper equivalents (brochures, posters, etc.) do.
If the assumption is correct, 21 CFR 801 and 820 are applicable to them and the content needs to be reviewed and therefore the Device History Record (DHR) updated with the reviewer and the date of the review. It seems to me a little unpractical to update the DHR when the product website is updated (although I understand the reasons for it). How do other people deal with this issue?
As an additional note, probably irrelevant to this post, We "manufacture" standalone software that is classified as a class II medical device.
Thank you in advance for your response,
esalsan
-------------------
Section 201 of the FD&C Act distinguishes between label and labeling. Certain provisions in Chapter V of the FD&C Act apply specifically to the "label" of the device, others are related to its "labeling." These terms are related, but not interchangeable. Of the two, the term "label" is more restricted. Generally, it consists of that art of the display confined to the device itself. On the other hand, "labeling" deals wit the label on the device, and descriptive and informational literature that accompanies the device.
Section 201 (k) defines "label" as a:
* "display of written, printed, or graphic matter upon the immediate container of any article.. . "
The term "immediate container" does not include package liners. Any word, statement, or other information appearing on the immediate contamer must also appear "on the outside container or wrapper, lf any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."
Section 20 1 (m) defines "labeling" as:
* "all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanyin such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
The term "accompanying" is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. "Accompanying" also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.