# Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/medical-device-reporting-for-manufacturers-guidance-for-industry-and-food-and-drug-administration-staff/bdf0f904-24f2-44f0-8046-74c1e429237a > FDA guidance document: Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff. Issue date: November 08, 2016. Get complete insights and analysis. --- ## Details - Title: Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff - Communication Type: Guidance Document - Product Type: devices - Office Name: Center for Devices and Radiological Health - Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7 - Issue Date: 2016-11-08 - Last Changed: 2019-02-09 - Docket Number: FDA-2013-D-0743 ## Related Documents - [M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality](https://www.globalkeysolutions.net/guidances/guidance-document/m4qr2-the-common-technical-document-for-the-registration-of-pharmaceuticals-for-human-use-quality/99d9c6a0-e416-4075-875d-80fbbf761ac7) - [CPG Sec 335700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure](https://www.globalkeysolutions.net/guidances/compliance-policy-guide-cpg/cpg-sec-335700-surgeons-gloves-and-patient-examination-gloves-defects-criteria-for-direct-reference-seizure/dc5fbf7d-82f7-4d88-b5d9-26a19906eb3e) - [Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/software-as-a-medical-device-samd-clinical-evaluation-guidance-for-industry-and-food-and-drug-administration-staff/745234d9-1b52-4aa1-aff4-297a93f801f8)