Does FDA allow e-labeling?

R

Rocke

Involved In Discussions
I have been unable to find any information on FDA's website concerning this.
As a manufacturer of IVDs for professional use (lab assays), we are allowed to supply IFUs on a website in Europe. The user accesses the correct IFU via a key-code given on the label, which also contains basic information for identification and contact information to the manufacturer.

Does anybody know if FDA accepts this approach or if they will insist on having a printed IFU included in the packaging?

Best regards
Camilla
 
S

SSchoepel

Involved In Discussions
I'm going to ask my question as part of this thread since it's related. We are software-only. We are delivering the user manual electronically with the software product from a website.

According to the FDA we have to provide a printed user manual if the customer requests it/is unable to access the electronic version.

Am I correct in assuming that since a hard copy user manual is not our primary media, it is a "secondary" FDA requirement, and we have no other manufacturing since it's software-only, that I do not need to consider or include the production of hard copy user manuals as a manufactured item? (21 CFR 820.70h)

Regards,
S. Schoepel
 
M

Mark Meer

Trusted Information Resource
It appears that the definitive regulation can be found in Title 21 / Chapter 9 / SubChapter V / Part A / Section 352 (F) which reads:
  • "(f) Directions for use and warnings on label
    Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost."
TL;DR: It appears electronic labeling is permitted in USA, with the only requirement being that:
  1. the device is professional use; and
  2. paper copy can be provided upon request.
 
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