FDA seeks public comment on ECT

The FDA is asking for comment to determine whether it should reclassify ECT to require "reasonable assurance of the safety and effectiveness" of the mechanical devices used for electroconvulsive therapy. ECT was already in use when the FDA codified mechanical devices, and hence grandfathered under a classification that today would require testing for safety and efficacy. In response to public interest and complaints, the FDA is deciding whether a "premarket approval" is necessary in the "completion of product development." The answer to this will influence whether they downgrade the classification under less stringent rules. Some consider this tantamount to deregulation......

Read more about the current controversy:
Mindfreedom

Psychiatry Weekly

To comment before Jan. 8, 2010:
Electronic submission: http://www.regulations.gov.

Written comments:
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Victor Krauthamer, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., W066-1106, Silver Spring, MD 20993, 301-796-2474.

Recovery, ECT, FDA comments

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