Bioelectronics Corp (BIEL)

[seven-up]

February 18, 2015 U.S. Food and Drug Administration
Division of Dockets Maragement
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re FDA-20 I 2-N-0378-DRAFT-03t 5

To whom it may concem:
Regenesis Biomedical, Inc. ("Regenesis'") submitted a comment to the docket pursuant
to the Proposed Order "Physical Medicine Devices; Reclassification and Renaming of Shortwave
Diathermy for All Other Uses" (79 Fed. Reg. 9671 (Feb. 20, 2014)) (Proposed Order) dated May 14,2014. This comment was submitted priot to lhe May 21,2014 deadline noted in the
Proposed Order and was assigned the number FDA-2012-N-0378-DRAFT-0315.
Since that time, several comments from Regenesis' industry have been posted to the regulations.gov website; but Regenesis' comment has not. Upon further review, we have noted
that the comment submitted to FDA stated "CONFIDENTIAL" in the footer. We do this as a matter of habit with extemal communications and this was done in error. We apologize for any
confusion this may have caused.
The comments submitted to FDA are not confidential and we are requesting that Regenesis' comment noted under FDA-2012-N-0378-DRAFT-0315 be posted to the regulations.gov website.

If you have any questions, you can contact

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0378-0060