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# Innovative Wants Restrictions on IB-Stim Equivalence
- URL: https://www.fdaweb.com/innovative-wants-restrictions-on-ib-stim-equivalence/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145377

Innovative Health Solutions is asking FDA not to make a determination of certain subject devices’ substantial equivalence to the IB-Stim without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. The 10/29 [petition](ttps://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-5048-0001&attachmentNumber=1&contentType=pdf) says that FDA issued a 6/7 classification order for non-implanted nerve stimulators for functional abdominal pain relief based on agency review of a *de novo* submission for the IB-Stim percutaneous electrical nerve field stimulator.

“While we applaud FDA’s commitment to reducing regulatory burdens through use of the *de novo* process, and paving the way for improved patient access to new, beneficial devices, we are concerned that the special controls promulgated for the classification are inadequate to assure the performance of any proposed device within this classification are inadequate to assure the performance of any proposed device within this classification that is not essentially identical to the IB-Stim, the only current predicate, in terms of product design, labeling, and indications for use,” the petition says.