Wash. Rev. Code » Title 19 · Chapter 19.28
Revised Code of Washington

Wash. Rev. Code § 19.28.371 (2025)

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

✓ laws through the 2025 session: 2026 session laws are not yet included
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(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 s 1; 1981 c 57 s 1. Formerly RCW 19.28.390.]
Notes of Decisions
Cited in 2 cases (2 in the last 5 years), 2024–2025 · leading case: Henry Schein, Inc., V. Dept. Of L & I, State Of Wa, No. 86858-6 (Wash. Ct. App. Nov. 25, 2024).
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Henry Schein, Inc., V. Dept. Of L & I, State Of Wa, No. 86858-6 (Wash. Ct. App. Nov. 25, 2024). · cites it 8× “B This case concerns the Department’s interpretation and application of RCW 19.28.371 to the actions performed by Stalford on behalf of Schein.”
Doyle v. Bayer Corp., No. 2:24-cv-01973 (W.D. Wash. June 12, 2025). “Pearson allege that Bayer breached their duty to them by failing to 8 meet the standard of care set by the FDCA and RCW 19.28.371, making Bayer negligent per se.”
Wash. Rev. Code § 19.28.371(2): 1 case
Henry Schein, Inc., V. Dept. Of L & I, State Of Wa, No. 86858-6 (Wash. Ct. App. Nov. 25, 2024). “B This case concerns the Department’s interpretation and application of RCW 19.28.371 to the actions performed by Stalford on behalf of Schein.”
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