FDA publishes List of Guidance Documents for Medical Devices

In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development  in the fiscal year 2012 (October 2011- September 2012). The reason for the creation of this list is based on negotiations over the reauthorisation of the Medical Device User Fee and Modernization Acts (MDUFMA). The Center for Devices and Radiological Health (CDRH) will be in charge of these documents. It is intended to help get safe and effective medical devices to the market more quickly.

The CDRH explicitly indicates that the list of the proposed documents isn't binding nor complete. For example, current situations - which are not in the list - may influence the development of new documents. However, the CDRH asks for feedback from the industry regarding the existing list in order to classify the priorities.

The list deals with the following topics: 

  • General Premarket Issues
  • Post market and Compliance Guidance
  • Devices Specific Guidances
  • Global Harmonization or Standards Related Guidances
  • Cross-Cutting, Process and other Guidances 

Regarding the topic Post market und Compliance, two Guidances on "Medical Device Reporting" are being planned. Moreover, one is being planned regarding Recalls and Annual Reports. Please also see the complete list.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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