Transparency site on medical radiation devices launched

Due to the recent events in connection with medical radiation-associated health problems, regulators in the US are taking steps to resolve these issues. The US FDA has recently launched its Center for Devices and Radiological Health (CDRH) Transparency Web site which provides “information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.”

To back track a bit, several studies have investigated radiation exposure of patients when undergoing diagnostic procedures that involved radiation-emitting devices, including the widely used computer tomography (CT) scans. These studies found that radiation levels used by these machines vary considerably and are not regulated. Previous research has shown strong links between radiation and cancer.

In addition, several cases of radiation overdose, some of them with very serious consequences, have been reported.

The new site covers the following:

• Premarket submissions for approved and cleared products – summaries of FDA’s review of the documents and data that companies submit to FDA when requesting clearance or approval to market a new or improved device, and the systems FDA uses to evaluate these submissions.
• Postmarket performance and safety – documents and data describing how well devices perform after they are on the market, and information about how FDA monitors medical device safety.
• Compliance and enforcement – official actions that FDA has taken in response to problems with devices or device companies.
• Science and research – research programs at CDRH or sponsored by CDRH.
• Educational resources – information to help industry and others understand CDRH requirements and processes.
• CDRH performance data – metrics about CDRH programs.

Information on clearance reviews and premarket approvals will be incorporated in the near future.

We as patienst and consumers hope that this initiative will improve the safety levels of medical radiation.

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