By virtue of the fact that Institutional Review Boards (IRBs) approved human clinical studies with D’OXYVA® and concluded that it was a Non-Significant Risk (NSR) device, D’OXYVA® has an approved Investigational Device Exemption (IDE). See 21 CFR 812 reference below in section (b) and (1) highlighted in CAPITAL LETTERS.
This means D’OXYVA can be used for any medical purposes under testing (investigations). Doctors can ask their patients if they would like to try and test D’OXYVA® for a certain period of time to see if it helps their condition. First, D’OXYVA should be used as an adjunct application combined with other therapies (no negative interference with other modalities has been reported to date). Typically, patients should test D’OXYVA® for the first time for 6-8 weeks twice a day for the first two weeks and then once a day to achieve best results according to various clinical trial results and user feedback with D’OXYVA® . Severe cases should continue using it twice a day for 4 weeks and then based on progress lower dosing to once a day.
(b) Abbreviated requirements. THE FOLLOWING CATEGORIES OF INVESTIGATIONS ARE CONSIDERED TO HAVE APPROVED APPLICATIONS FOR IDE’S, unless FDA has notified a sponsor under 812.20(a) that approval of an application is required:
(1) AN INVESTIGATION OF A DEVICE OTHER THAN A SIGNIFICANT RISK DEVICE, if the device is not a banned device and the sponsor:
(i) Labels the device in accordance with 812.5;
(ii) OBTAINS IRB APPROVAL OF THE INVESTIGATION AFTER PRESENTING THE REVIEWING IRB WITH A BRIEF EXPLANATION OF WHY THE DEVICE IS NOT A SIGNIFICANT RISK DEVICE, AND MAINTAINS SUCH APPROVAL;
(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator’s care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 56.109(c).
(iv) Complies with the requirements of 812.46 with respect to monitoring investigations;
(v) Maintains the records required under 812.140(b) (4) and (5) and makes the reports required under 812.150(b) (1) through (3) and (5) through (10);
(vi) Ensures that participating investigators maintain the records required by 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and
(vii) Complies with the prohibitions in 812.7 against promotion and other practices.