United States · Bill · S
S. 4386 (117th)
A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
Introduced
13 June 2022
Last action
—
Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
—
Subjects
Discovery layer
Source updated
5 December 2025
Summary
This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
No timeline events have been ingested for this record yet.
Votes
No vote records are attached yet.
Versions
No version snapshots stored. Document URLs remain at the source.
Documents
3 official files
Introduced in Senate (text)
Introduced in Senate (text)
Introduced in Senate · EN · 13 June 2022
Introduced in Senate (PDF)
Introduced in Senate · EN · 13 June 2022
Introduced in Senate
summary · EN · 13 June 2022
Sponsors
No sponsors or actors listed by the source.
Related records
No cross-record relationships stored yet.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/4386
- Open data entity: https://api.congress.gov/v3/bill/117/s/4386