FDA Reporting Guidance for Medical Device Manufacturers | Practical Law

FDA Reporting Guidance for Medical Device Manufacturers | Practical Law

The Food and Drug Administration (FDA) has recently issued guidance for medical device manufacturers to explain the agency's requirements for reporting device-related adverse events and malfunctions.

FDA Reporting Guidance for Medical Device Manufacturers

Practical Law Legal Update w-004-7925 (Approx. 3 pages)

FDA Reporting Guidance for Medical Device Manufacturers

by Practical Law Commercial Transactions
Published on 30 Nov 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has recently issued guidance for medical device manufacturers to explain the agency's requirements for reporting device-related adverse events and malfunctions.
The Food and Drug Administration (FDA) recently issued Medical Device Reporting for Manufacturers: Guidance for Industry and Food and Drug Administration Staff to help medical device manufacturers understand their reporting obligations for device-related adverse events and malfunctions under the FDA's Medical Device Reporting (MDR) regulations (21 C.F.R. §§ 803.1-803.58).
This guidance does not establish legally enforceable responsibilities. It simply describes the FDA's current thinking on manufacturers' obligations under the MDR regulations and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
For more information on the FDA's requirements for reporting device-related adverse events and malfunctions , see Practice Note, FDA Medical Devices Regulations: Mandatory Reporting Obligations.