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US FDA The "Traditional"510(k) (Part 8) 

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. 

We noted that FDA's Center for Devices and Radiological Health (CDRH) announced that it would allow the use of "Rx only" instead of the traditional prescription warning. We also discussed Electronic Labeling and electronic submissions. 

In this column, we will continue discussion of labeling with a discussion of labeling of radiation-emitting products. 

Labeling of Radiation-Emitting Products

Before we discuss labeling requirements for radiation-emitting products, we should get some guidance as to whether our device would be considered to be radiation-emitting. Let us look at the definitions. According to section 531 of the FD&C Act:

(1) The term "electronic product radiation" means - 

(A) Any ionizing or non-ionizing electromagnetic or   particulate radiation, or
(B) Any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product; 

(2) The term "electronic product" means 

(A) Any manufactured or assembled product which, when in operation, 

(i) Contains or acts as part of an electronic circuit and 

(ii) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or 

(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation; 
The term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products. 

The FDA regulates all radiating-emitting products-whether or not they are medical devices. The FDA has specific requirements that apply to all radiation emitting electronic products. 

It is important to understand that most radiation-emitting products are not considered to be medical devices. They "become" medical devices when you make any medical claims for them. When that happens, your product is considered to be a medical device and is subject to the provisions of the FD&C Act for medical devices in addition to the provisions for radiation emitting products.

Some examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.15 and include:

Note that products that emit radiation as a result of the decay of a radioactive element or isotope are excluded from the definition of radiation-emitting products.

Certain radiation emitting products require the submission of product reports to FDA and the retention of records as included in 21 CFR Part 1002 and in a table that can be found at http://www.fda.gov/cdrh/devadvice/311.html. In addition, all manufacturers of electronic products are subject to the reporting of accidental radiation occurrences, as required by 21 CFR 1002.20.

General labeling requirements for electronic products and special labeling requirements for products that emit ionizing radiation, microwaves, light and ultrasonic radiation can be found at http://www.fda.gov/cdrh/devadvice/335.html

In future columns we will conclude our overview of labeling requirements and move on to 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
June 2004

If you  have questions related to the contents of this column, please write to Dr Norman Estrin at yourFDAconsultant@medisourceasia.com 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. 

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