Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments

الملخص

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is requesting comments concerning the possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children. This action is being taken to assist the agency in preparing a report to Congress required by the Medical Devices Technical Corrections Act of 2004 (MDTCA).