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22 B.U. J. Sci. & Tech. L. 267 (2016)
Regulating the Three-Dimensional Future: How the FDA Should Structure a Regulatory Mechanism for Additive Manufacturing (3D Printing)

handle is hein.journals/jstl22 and id is 283 raw text is: NOTE REGULATING THE THREE-DIMENSIONAL FUTURE: HOW THE FDA SHOULD STRUCTURE A REGULATORY MECHANISM FOR ADDITIVE MANUFACTURING (3D PRINTING) Ariel M. Nissan* INTRODUCTION ................................................. ....... 268 I. BACKGROUND ....................................................... 270 A. Overview of 3D Printing.......................... 271 B. Quality Control. ................................ ..... 274 II. CURRENT TRENDS IN FDA REGULATION .............................. 276 A. Emergency Use Devices ...................... ......... 279 B. Approved 3D Printed Products ............................. 280 C. Material Considerations. .............................. 283 III. THE CASE FOR (OR AGAINST) REGULATION ........................... 283 A. Regulating Specific Devices and Manufacturing Facilities May Be More Efficient. .................................. 285 1. Device manufacturers should be responsible for verification and validation of manufacturing methods.......... 286 2. Discomfort with manufacturing techniques could be attributed to uncertainty in the regulation of customizable devices....................................... 287 3. Although Quality Systems Regulations would ensure manufacturing facilities of end use devices adhere to good manufacturing practices, 3D printers complicate the definition of manufacturer ....................... 288 4. Enhanced regulation on materials would be more helpful than regulating individual printers.................... 290 B. Other forms of quality control are available ........................ 291 1. Industry quality standards and terminology outside of the FDA can ensure quality of 3D printers ........ ........... 291 2. Device manufacturers have a strong incentive to invest in quality machines; therefore, machines that do not produce sound devices will not be utilized. .................... 292 C. FDA Regulations Would Unduly Burden 3D Printer * Ariel Nissan is currently employed by Formlabs Inc., a manufacturer and designer of the Form 2, a desktop 3D printer. The opinions expressed in this note are solely her own and may not express the views or opinions of her employer. 267

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