Zdrowie i gospodarka · 05/04/2002

Medical Devices: Draft Guidance on Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA." This draft guidance document was developed as a special control to support the classification of intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea into class II and to provide guidance to manufacturers attempting to establish that their intraoral devices for snoring and obstructive sleep apnea are substantially equivalent to a predicate device. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify these devices. This draft guidance is neither final nor is it in effect at this time.