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These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D\u2010printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D\u2010printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D\u2010printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D\u2010printed bioresorbable implantable device.<\/jats:p>","DOI":"10.1111\/cts.12315","type":"journal-article","created":{"date-parts":[[2015,8,3]],"date-time":"2015-08-03T08:53:06Z","timestamp":1438591986000},"page":"594-600","source":"Crossref","is-referenced-by-count":273,"title":["Regulatory Considerations in the Design and Manufacturing of Implantable 3D\u2010Printed Medical Devices"],"prefix":"10.1111","volume":"8","author":[{"given":"Robert J.","family":"Morrison","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2010Head &amp; Neck Surgery University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khaled N.","family":"Kashlan","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head &amp; Neck Surgery University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen L.","family":"Flanangan","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne K.","family":"Wright","sequence":"additional","affiliation":[{"name":"Michigan Institute for Clinical &amp; Health Research IND\/IDE Investigator Assistance Program University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn E.","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head &amp; Neck Surgery Division of Pediatric Otolaryngology University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott J.","family":"Hollister","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J.","family":"Weatherwax","sequence":"additional","affiliation":[{"name":"Michigan Institute for Clinical &amp; Health Research IND\/IDE Investigator Assistance Program University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,8,3]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"32993","volume":"43","author":"Medical Device Classification Procedures","year":"1978","journal-title":"Fed Regist"},{"key":"e_1_2_8_3_1","first-page":"32993","volume":"43","author":"Classification of Implants, Life\u2010supporting or Life\u2010sustaining Devices","year":"1978","journal-title":"Fed Regist"},{"key":"e_1_2_8_4_1","first-page":"64625","volume":"63","author":"Investigational Device Exemptions: Supplemental applications","year":"1998","journal-title":"Fed Regist"},{"key":"e_1_2_8_5_1","first-page":"26364","volume":"51","author":"Premarket Approval of Medical Devices","year":"1986","journal-title":"Fed Regist"},{"key":"e_1_2_8_6_1","unstructured":"U.S. Department of Health and Human Services: Requests for Feedback on Medical Device submissions: the Pre\u2010Submission Program and Meetings with Food and Drug Administration.Guidance for Industry and Food and Drug Administration Staff.http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM311176.pdf. 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