Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff
Published: 2010-09-29
Status: Final Type: Guidance Document Category: Labeling / UDI Topics: Postmarket, Labeling Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/addition-urls-electronic-product-labeling PDF: https://www.fda.gov/media/79209/download
Official Full Text
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Identification Labels Manufacturers of electronic products are required to include their full name and address and place, month and year of manufacture on their product’s identification tag or label (21 CFR 1010.3(a)(1) and (2)). CDRH recommends that, when feasible, the manufacturer add its URL to its electronic product tag or label, in addition to the identification information required under 21 CFR 1010.3(a)(1) and (2). CDRH does not, however, recommend inclusion of the URL in instances where a manufacturer is unable to place its URL, in addition to the required full name and address and place, month and year of manufacture, on its current product label in a manner that is legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable performance standard. When a manufacturer adds its URL to a product tag or label, the URL should point directly to:
A web page where the manufacturer’s full name and current physical address are posted, or
A web page which displays an easily identifiable link (e.g. “Contact Us”) that connects to a web page where the manufacturer’s full name and current physical address are posted.
In addition, the manufacturer’s physical address should be kept current on the manufacturer’s website by updating any change to its physical address no later than 15 days following a change.
Under certain circumstances, FDA may determine that information about an electronic product on a firm's website is "labeling" within the meaning of section 201(m) of the Federal Food, Drug, and Cosmetic Act. The presence of the URL on the product label is one factor the Agency may consider in making such a determination.