Sens. Tammy Baldwin (D-Wis.) and Bill Cassidy (R-La.) introduced the Medical Device Integrity Act on Dec. 14, 2021, a bill they say will support USA-made medical supplies.
The bill, S. 3395, would let the FDA require medical device makers to respond to records requests. The FDA can already require this for drug makers but not for device makers. Most PPE, including masks and gloves, counts as a medical device.
Key details
- Baldwin’s office said about 40% of device facilities did not submit records when asked from February to May 2021.
- The sponsors said remote records requests would help the FDA fight counterfeit devices, most of which come from abroad.
- Cassidy noted that China embargoed PPE made by U.S. companies early in the pandemic.
“This legislation supports production back home and strengthens our defense against future outbreaks.”
Sen. Bill Cassidy
FAQ
What is the bill number?
S. 3395.
What power would FDA gain?
The power to require device makers to answer records requests.
Who sponsored it?
Sens. Tammy Baldwin and Bill Cassidy.
Source & credit
Source: Office of Sen. Tammy Baldwin, Dec. 14, 2021: “Senator Baldwin Introduces Bipartisan Legislation to Increase Pandemic Preparedness and Support Made in America Medical Supplies”.
Also: Medtech Insight, Dec. 17, 2021: “Sens. Baldwin And Cassidy Want Medical Devices Made In The USA”.