The美国食品和药物管理局（FDA）已向五个研究机构授予了赠款，以研究和改进生物制造，包括3D生物打印。
医学博士Scott Gottlieb，FDA专员说：“高级制造技术，例如持续制造，对生物产品制造的可靠性，灵活性和成本效益的提高充满希望。”
“我们向五个全球认可的研究机构授予了赠款，以研究可以实施最先进的制造技术来促进这些目标的方法，并实现对生物产品的更具创新性，一致性和可靠的制造”。
Each research institute will focus on a specific area in the field of biomedicine. The five institutes granted the award are:
–Harvard University, Cambridge, Massachusetts, $599,910
–卡内基·梅隆大学，宾夕法尼亚州匹兹堡，$ 599,844
–罗格斯大学, Piscataway, New Jersey, $600,000
–佐治亚理工学院，佐治亚州亚特兰大，60万美元
–麻省理工学院，剑桥，马萨诸塞州，60万美元
卡内基 - 梅隆大学（Carnegie-Mellon University）将重点放在“满足细胞外基质支架3D打印的关键制造需求”上。
21st Century Cures Act
The FDA invoked the21st Century Cures Act(Cures Act) to award the five grants. The Cures Act (December 13, 2016) gives the federal agency the authority to develop projects that would accelerate innovations in medicine.
Such projects include the再生医学高级治疗（rmat），Breakthrough Devices program.
RMAT is an expedited option for eligible biological products.这些产品包括再生医学治疗药物，旨在治疗威胁生命的疾病的药物以及具有“应对威胁生命的疾病未满足医疗需求的潜力”的药物。
The Breakthrough Devices program speeds up the review process of certain medical devices. For a medical device to be considered under this program it is necessary to prove:
- 该设备比当前可用的治疗方法更有效地治疗威胁生命状况
– the device is a breakthrough technology and no approved alternative is marketed in the U.S
- 该设备比现有替代方案改进了解决方案
– The availability of the device is in the best interest of patients
FDA和3D打印技术
The FDA has been actively supporting the adoption of 3D printing technology in the biomedical and dental industry. Last year the agency made a statement regarding its commitment to the technology and releasedguidelines for manufacturers submitting 3D printed implantsand other medical devices.
Many3D印刷公司对FDA guidelines. Since then there has been a surge in 3D printed medical devices and their approval by the FDA.
In 2017,SI-BONE，制造商手术植入物，宣布了FDA的专利许可iFuse Implant System， A3D printed titanium implant for SI joint. The same year,3D printed Cellular Titanium脊柱支撑植入物byEmerging Implant Technologies， AGerman spinal implants manufacturer, were approved by the FDA.
今年早些时候，Carbon 3D的Dentca义齿基地IIandDENTCA Denture Teeth，牙科行业的3D可打印树脂获得了FDA的II类批准。
Since the Cures Act’s clarification on software as a medical device,Materialise Mimics Innovation Suiteused for 3D printed anatomical parts for diagnostic purposes, became the first medical software to receive Class II certification from the FDA.
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Featured image shows the surface structure of an FDA approved 3D printed cellular titanium implant. Image via EIT.
