19.28.371 - Medical device -- Installation, maintenance, or repair -- Compliance with chapter -- Limit of exemption. - Washington Statutes

Medical device — Installation, maintenance, or repair — Compliance with chapter — Limit of exemption.

(1) A medical device which is not in violation of the Medical Device Amendments of 1976, Public Law No. 94-295, 90 Stat. 539, as amended from time to time, and as interpreted by the Food and Drug Administration of the United States Department of Health and Human Services or its successor, shall be deemed to be in compliance with all requirements imposed by this chapter.

     (2) The installation, maintenance, or repair of a medical device deemed in compliance with this chapter is exempt from licensing requirements under RCW 19.28.091, certification requirements under RCW 19.28.161, and inspection and permitting requirements under RCW 19.28.101. This exemption does not include work providing electrical feeds into the power distribution unit or installation of conduits and raceways. This exemption covers only those factory engineers or third-party service companies with equivalent training who are qualified to perform such service.

[2003 c 78 § 1; 1981 c 57 § 1. Formerly RCW 19.28.390.]