Regulatory research on IDE exemptions

A case study in persistence (part 2)

In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic device for monitoring a physiological signal would be exempt from FDA IDE regulations under 21 CFR 812.2(c)(3). The regulation does not define some key phrases and FDA has not published guidance on these exemptions.  So what did we do?

Rather than calling FDA or hiring a lawyer, we decided to look more closely at the regulation, specifically at the end where it states:

“[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan. 29, 1997; 62 FR 12096, Mar. 14, 1997]”

The end of each regulation lists the Federal Register notices where it was finalized and/or amended. In this case, the original regulation was finalized in the 45th volume of the Federal Register on January 18, 1980 and was amended five times after that.  Each notice includes a preamble in which FDA addresses comments on the proposed regulation or amendment.  FDA’s discussion of comments constitutes an advisory opinion, i.e., guidance that is binding on FDA.  We looked for the original Federal Register notice at this FDA webpage and were presented with two alternatives under the heading, Historical to Present Federal Register documents:

“• GPO Federal Register Database (1994 to present)
HeinOnline provides online access to Federal Registers from 1936-forward”

The second link is a paid subscription database.  The first link seems to not go back far enough: the original regulation is from 1980.  Or does the linked database really stop at 1994?  Faced with having to sign up for a paid subscription database, we went ahead and clicked on the link.  Lo and behold, it has free Federal Register notices all the way back to 1936.  With a few more clicks, we found the January 18, 1980 Federal Register notice.  On page 3738, at comment 22, FDA states:

“Devices that are designed to emit energy are subject to this regulation because FDA has determined that there is no way to specify an acceptable or safe limit of energy. However, devices such as investigational electrocardiographs and electroencephalographs that are not intended to introduce energy into the body but do so only from leakage are not subject to the final IDE regulation if the sponsor meets the other conditions of § 812.2(c)(3).”

Case closed: Electrocardiographs and electroencephalographs are electronic devices that monitor physiological signals.  FDA considers them to not introduce energy into the body by design or intention.  Neither does our client’s device.  So, if our client complies with the other conditions of 21 CFR 812.2(c)(3), their clinical study will be exempt from IDE regulation.  (Note: We advise to nevertheless conduct the study in accordance with IRB and informed consent regulations.) The client was pleased with our research.

Lessons learned (or relearned):

  • Regulatory research, like all research, is hard work, and can take considerable time and effort. These blog posts are a summary of how we got to our final answer.  They do not include all of the blind alleys we went down getting to the final answer.
  • Go beyond guidance and regulation. When neither is clear or even if they seem clear, read the underlying Federal Register notices and the associated regulatory history and preambles. (This one was 30 pages, but was searchable.)
  • Website links are not always accurate or up-to-date. So keep on searching (or, in this case, keep on clicking).

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