SB 605

  • California Senate Bill
  • 2021-2022 Regular Session
  • Introduced in Senate Feb 18, 2021
  • Senate
  • Assembly
  • Governor

Medical Device Right to Repair Act.

Abstract

The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. Among other things, the law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility. Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure. This bill would enact the Medical Device Right to Repair Act, and would require an original manufacturer of powered medical equipment used in the treatment, monitoring, or diagnosis of a patient to provide documentation, parts, service access methods, and tools used to inspect, diagnose, maintain, and repair powered medical equipment to a hospital and an independent service organization engaged by the hospital for the purpose of providing medical equipment maintenance and repair, on fair and reasonable terms, as defined. The bill would exempt from these requirements any trade secret information. The bill would subject an original equipment manufacturer who knowingly violates these provisions to specified civil penalties, and would authorize the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose.

Bill Sponsors (4)

Votes


Actions


Feb 01, 2022

Senate

Returned to Secretary of Senate pursuant to Joint Rule 56.

May 20, 2021

Senate

May 20 hearing: Held in committee and under submission.

May 14, 2021

Senate

Set for hearing May 20.

May 10, 2021

Senate

May 10 hearing: Placed on APPR suspense file.

May 04, 2021

Senate

Set for hearing May 10.

Apr 29, 2021

Senate

Read second time and amended. Re-referred to Com. on APPR.

  • Amendment-Passage
  • Reading-1
  • Reading-2
  • Referral-Committee
Com. on APPR.

Apr 28, 2021

Senate

From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 9. Noes 0. Page 936.) (April 27).

Apr 16, 2021

Senate

Set for hearing April 27.

Apr 15, 2021

Senate

Read second time and amended. Re-referred to Com. on JUD.

  • Amendment-Passage
  • Reading-1
  • Reading-2
  • Referral-Committee
Com. on JUD.

Apr 14, 2021

Senate

From committee: Do pass as amended and re-refer to Com. on JUD. (Ayes 10. Noes 0. Page 795.) (April 14).

Mar 26, 2021

Senate

Set for hearing April 14.

Mar 03, 2021

Senate

Referred to Coms. on HEALTH and JUD.

  • Referral-Committee
Coms. on HEALTH and JUD.

Feb 22, 2021

Senate

Art. IV. Sec. 8(a) of the Constitution dispensed with.

Senate

Joint Rule 55 suspended. (Ayes 32. Noes 4. Page 272.)

Senate

(Ayes 32. Noes 4.)

Feb 19, 2021

Senate

From printer. May be acted upon on or after March 21.

Feb 18, 2021

Senate

Introduced. Read first time. To Com. on RLS. for assignment. To print.

Bill Text

Bill Text Versions Format
SB605 HTML
02/18/21 - Introduced PDF
04/15/21 - Amended Senate PDF
04/29/21 - Amended Senate PDF

Related Documents

Document Format
04/13/21- Senate Health PDF
04/23/21- Senate Judiciary PDF
05/07/21- Senate Appropriations PDF

Sources

Data on Open States is updated periodically throughout the day from the official website of the California State Legislature.

If you notice any inconsistencies with these official sources, feel free to file an issue.