---
title: Draft Guidance on Medical Device Reporting for Manufacturers Released by US FDA
description: Draft Guidance on Medical Device Reporting for Manufacturers Released by US FDA
---

[Commentary & Analysis - Compliance & Risks](https://go.adherent.com/commentary-analysis-old)

# [Draft Guidance on Medical Device Reporting for Manufacturers Released by US FDA](https://go.adherent.com/commentary-analysis-old/draft-guidance-on-medical-device-reporting-for-manufacturers-released-by-us-fda)

 Written by [complianceandrisk](https://go.adherent.com/commentary-analysis-old/author/complianceandrisk) | Jul 9, 2013, 2:08:24 PM

The US Food and Drug Administration (FDA) has published its draft guidance entitled ‘Medical Device Reporting for Manufacturers’, setting out the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.

Submissions on the guidance should be received by October 7, 2013 to ensure that the Agency considers comments prior to its work on the final version.

This draft guidance is not final nor is it in effect at this time, but is intended to update FDA’s policy and to further clarify FDA’s interpretations of the regulation requirements.  Once finalized, it will supersede the previous manufacturer guidances issued in 1988 and 1997.

For further information, please [contact us](http://www.complianceandrisks.com/contact/).

[View full post](https://go.adherent.com/commentary-analysis-old/draft-guidance-on-medical-device-reporting-for-manufacturers-released-by-us-fda)

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