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US FDA The “Traditional”510(k) 

- Part VII

In the last column (See Archives), we continued a discussion of the "Traditional" Premarket Notification (510(k)) submission to the FDA. We discussed Labels and Labeling. 


In this column, we will continue discussion of labeling with a discussion of prescription device labeling. 

Prescription Drug Labeling

Prescription devices are those sold for use by licensed healthcare practitioners rather than sold directly to lay persons. Such products do not need adequate directions for use, which are necessary for lay users. They must, however, contain a caution label. Until recently, that required statement was: "Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner)." (See 21 Code of Federal Regulations (CFR) sec. 801.109(b)(1)). The device would be considered to be misbranded if it did not contain this statement and would not be permitted to enter domestic commercial distribution.

The FDA Modernization Act of 1997 (FDAMA) amended the law to allow prescription drug products to label their drugs with the symbol statement "Rx only" instead of the caution statement above. FDA's Center for Devices and Radiological Health (CDRH) recently announced that it will allow use of the statement "Rx only" as an alternative to the prescription device caution statement above. CDRH makes it clear that "Only" needs to immediately follow "Rx." CDRH also advises that the symbol statement "Rx only" does not necessarily need to be bracketed in quotation marks, and the word "only" may appear in upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY.

This symbol statement "Rx only" should appear on the main panel of the container label and device labeling where space permits. It should be prominent and conspicuous, whether by the font size, the use of capital letters or bold print, as described in section 502(c) of the act and the related regulatory requirements for medical device labeling found in 21 CFR 801.15. Both the symbolic statement and the above longer caution statement can be used for the same product, if desired.

This substitution of the Rx Only symbol for the longer prescription caution statement also applies to all in vitro diagnostic (IVD) devices that would require this caution statement, including in vitro diagnostics labeled, "for professional use" or "for prescription home use." 

Electronic Labeling

The use of electronic labeling instead of the widely used paper labeling is now authorized under special circumstances under Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA). Now, distributors of prescription devices for use in a health care facility may provide labeling for those devices solely in electronic form. They must, however, also allow users the opportunity to request the paper labeling and promptly provide such labeling to requestors without additional cost. 

Note that the new provision uses the term "electronic labeling," rather than terms, such as computer discs, computer diskettes, computer hard drives, or the Internet. This was done to ensure that the law allows for future change in information technology.

The FDA was concerned that many homes do not have personal computers and, therefore limited this provision to Rx devices intended for use in health care facilities. Over-the-counter (OTC) devices and Rx devices intended for home use cannot substitute electronic labeling for paper labeling.

Of course, labeling in electronic labeling, like paper labeling must not be false or misleading and must meet all other applicable regulatory requirements, such as those contained in 21 CFR Parts 801 and 809.

Just converting paper labeling to an electronic form should not require the submission of a new 510(k). Making other changes in labeling or technology might require a new 510(k). Consult to determine whether the changes in labeling significantly impact the design of the device or its the safety and effectiveness.

Electronic 510(k) Submissions

All premarket applications still need to include a paper copy of the labeling and will continue to do so until FDA is equipped to review electronic submissions without an accompanying paper copy. See for detailed information regarding electronic submissions.

Manufacturers of new or significantly modified devices who intend to provide labeling to users strictly in an electronic form are being encouraged to provide proposed labeling for their devices to Office of Device Evaluation (ODE)/Office of In Vitro Diagnostic Device Evaluation (OIVD) in the same form that it will be provided to health care facilities. Therefore, submissions may include labeling in an electronic format (e.g., CD ROM) or refer to the device manufacturer's website for the labeling. 

The FDA will permit submissions to reference the Internet for labeling when: 

(1) The device that is the subject of the 510(k) submission is available in the international marketplace and the proposed U.S. labeling does not differ. 

(2) FDA is provided an identification code that permits access to electronic labeling at the firm's website for review purposes only.  

A paper copy of the labeling must be included in the application for applications that reference a website. The 510(k) must also include a statement that the labeling on the website is identical to that contained in the submission since labeling on the internet is subject to change.  

When the FDA review of the 510(k) results in labeling changes, the submission must be amended to reflect all agreed upon changes. This means that the submitter must provide an updated paper copy of the revised labeling that reflects the agreed upon changes. The submission must be amended to contain a paper copy of the revised labeling and the website should be immediately updated before ODE/OIVD provides a final decision on the submission.
See the FDA "Blue Book Memo" on electronic labeling for further guidance:

In future columns we will discuss additional labeling considerations as well as other sections of the 510(k):

9. Performance Testing 
10. Clinical Data
11. Substantial Equivalence Information
12. Information on Sterilization
13. Software
14. Applicable Standards 
15. 510(k) Summary or Statement

Stay safe and healthy!

Norman F. Estrin, Ph.D., RAC
March 8, 2004





If you  have questions related to the contents of this column, please write to Dr Norman Estrin at and he will try to answer you.  This column is for you and we welcome your suggestions on how to improve it. 

Visit "Experts' Forum" section to view the replies of questions related to this column by Dr. Norman Estrin. 

Dr. Norman Estrin is a recognized authority in the medical device and cosmetic industries.  He has had over 30 years of experience in directing scientific and technical and regulatory programs in these industries.  He is Regulatory Affairs Certified (“RAC”) by the Regulatory Affairs Professional Society. Dr. Estrin is the founder of ESTRIN CONSULTING GROUP, INC. (ECG).  ECG offers cost-effective, experienced consulting to medical device firms on FDA- related issues.  Its Services include preparing 510(k) and other FDA submissions, regulatory strategy development    and acting as agent and official correspondent for non-U.S. medical device companies.

For more information, contact him at or visit his website:



 Please understand that in order to make FDA requirements more understandable, I do simplify some of the language and omit some details. You must rely on the actual regulations-not any of my columns to ensure you meet FDA requirements.


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