Cranial Technologies

Regulatory of the Cranial Orthosis

Regulatory History

Cranial Technologies is a pioneer in the development of cranial remodeling devices. In 1992, the first U.S. patent for a cranial remolding orthosis was issued to Cranial Technologies for their DOC Band®. In 1998, the DOC Band became the first cranial device cleared by the FDA for treating abnormal head shapes in infants, leading the FDA to create a whole new medical device category. This new device category in the U.S. is known as the cranial orthosis (21 CFR 882.5970).

The DOC Band became the first medical device of any kind to undergo the DeNovo petition process, a new pathway for market clearance established by Congress for innovative devices with no existing predecessors (i.e., predicate devices). To learn more – please see the following references:

  • DeNovo 1,2,3
  • FDA History 4,5
  • Regulatory Clearances 6,7,8

1. “Section 207: Is Your Class III Designation Really Final?” Dunning N.H., Littlefield T.R. Medical Device and Diagnostic Industry, 1999.
2. “Plagiocephaly Device First to Avoid Class III Status Via FDAMA Provision.” The Gray Sheet, 1998.
3. “Part 682- Neurological Devices.” Federal Register, vol 63(146), 1998.
4. “Food and Drug Administration Regulation of Orthotic Cranioplasty.” Littlefield T.R. Cleft Palate-Craniofacial Journal, vol 38(4), 2001.
5. “FDA Regulation of Cranial Remolding Devices.” Littlefield T.R. Journal of Prosthetics and Orthotics, vol 16(4), 2004.

Cranial Technologies, Inc.

Annual Compliance Declaration (January 16, 2024)

California Health and Safety Code § 119400-119402

California Declaration of Compliance

Cranial Technologies, Inc. (“Cranial”) is committed to complying with all applicable laws, regulations, and industry standards. Towards this end, Cranial has developed a Comprehensive Compliance Program in accordance with pharmaceutical industry compliance program guidance published by the U.S. Department of Health and Human Services Office of Inspector General (“OIG”). Cranial’s Compliance Program includes Standards of Conduct and policies and procedures that all Cranial employees, officers, and directors are required to follow. Cranial regularly reviews and updates its Compliance Program to ensure consistency with any new laws or guidance. The Compliance Program is designed to prevent, detect and remediate violations of law, regulations and company policies, as well as to promote an ethical culture that will guide Cranial’s interactions with healthcare professionals and entities. Based on a good faith understanding of the requirements of Section 119402 of the California Health and Safety Code, Cranial declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG’s guidance, the PhRMA Code and limits on gifts and incentives to healthcare professionals. Cranial also declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of January 16, 2024. A copy of Cranial’s Comprehensive Compliance Program is available here, or by calling 866-403-6361.

Natalie Kehm
Chief Compliance Officer
Corporate Social Responsibility Coordinator

COM001 Rev17 ECO24-011 Effective Date: 01/22/2024