{"content":[{"text":"K191226 - David L. Rogers","bbox":{"left":0.07067,"top":0.041684,"width":0.21827799999999997,"height":0.020212}},{"text":"Page 2","bbox":{"left":0.854706,"top":0.041684,"width":0.05297400000000008,"height":0.020212}},{"text":"devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see \n https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- \n combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) \n regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for \n combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- \n 542 of the Act); 21 CFR 1000-1050.","bbox":{"left":0.07067,"top":0.088174,"width":0.852794,"height":0.107182}},{"text":"Also, please note the regulation entitled, \"Misbranding by reference to premarket notification\" (21 CFR Part \n 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part \n 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting- \n mdr-how-report-medical-device-problems.","bbox":{"left":0.07067,"top":0.210523,"width":0.8504419999999999,"height":0.07178999999999999}},{"text":"For comprehensive regulatory information about medical devices and radiation-emitting products, including \n information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- \n devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn \n (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the \n Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See \n the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- \n assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE \n by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).","bbox":{"left":0.07067,"top":0.297492,"width":0.8573270000000001,"height":0.14256100000000005}},{"text":"Sincerely,","bbox":{"left":0.454167,"top":0.45421,"width":0.07545100000000005,"height":0.020212000000000008}},{"text":"Laurence D. Coyne -S","bbox":{"left":0.456944,"top":0.500286,"width":0.249189,"height":0.026294999999999957}},{"text":"Laurence D. Coyne, Ph.D. \n Assistant Director \n DHT6C: Division of Restorative, Repair \n and Trauma Devices \n OHT6: Office of Orthopedic Devices \n Office of Product Evaluation and Quality \n Center for Devices and Radiological Health","bbox":{"left":0.454167,"top":0.541179,"width":0.343499,"height":0.12536400000000003}},{"text":"Enclosure","bbox":{"left":0.07067,"top":0.6807,"width":0.07535300000000002,"height":0.020212000000000008}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}