SPADA Meeting Book

(36) Food and Drug Adminstration (2017) Guidance for Industry and Other Stakeholders: 1091 Emergency Use Authorization of Medical Products and Related Authorities . Office of 1092 Counterterrorism and Emerging Threats. Available from: https://www.fda.gov/regulatory- 1093 information/search-fda-guidance-documents/emergency-use-authorization-medical- 1094 products-and-related-authorities, accessed 30 May 2019. 1095 (37) Food and Drug Adminstration, How to Submit a Pre-EUA for In vitro Diagnostics. 1096 Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal- 1097 regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda , accessed 30 1098 May 2019. 1099 (38) Food and Drug Administration (2019) Guidance for Industry and Food and Drug Administration 1100

1101

Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission

1102

Program. Center for Devices and Radiological Health. Available from:

1103

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/

1104

ucm311176.pdf , accessed 30 May 2019.

1105

(39) Food and Drug Adminstration., Available from:

https://www.fda.gov/downloads/medicaldevices/.../ucm284443.pdf . 1106 (40) Food and Drug Adminstration (2017) Guidance for Industry and Food and Drug Administration 1107

Commented [SB27]: This link is forbidden – you need  permission to access.   Not sure what can be done. Perhaps, if one wants to access  they have to get permission.

1108

Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA

1109

Review Clock and Goals. Center for Devices and Radiological Health. Available from:

1110

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/

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ucm089738.pdf , accessed 30 May 2019.

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(41) Food and Drug Adminstration. Nucelic Acid Based Tests. Available from:

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https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm330711.

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htm , accessed 30 May 2019.

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