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Easier Access for Non-Invasive Diagnostic Devices

This bill aims to exempt certain non-invasive diagnostic devices from regulation as medical devices. This means devices that do not penetrate the skin or body tissues will not require as stringent approvals, potentially speeding up their market availability and reducing costs. For citizens, this could mean quicker access to new, simpler medical diagnostic methods.
Key points
Diagnostic devices that do not enter the body (e.g., do not break the skin) will no longer be treated as medical devices subject to strict regulations.
This change may accelerate the market introduction of new, safe diagnostic methods, potentially lowering their prices and increasing patient access.
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Status:
Expired
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Additional Information
Medical Innovation Acceleration Act of 2022
Print number: HR 6513
Sponsor: Rep. Biggs, Andy [R-AZ-5]
Process start date: 2022-01-28
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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Summary & Status

Key Questions about Easier Access for Non-Invasive Diagnostic Devices

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is HR 6513.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2022-01-28.

What are the main provisions?

Key points include:

  • Diagnostic devices that do not enter the body (e.g., do not break the skin) will no longer be treated as medical devices subject to strict regulations.
  • This change may accelerate the market introduction of new, safe diagnostic methods, potentially lowering their prices and increasing patient access.

What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Biggs, Andy [R-AZ-5].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-28.

Analysis and Potential Impact of HR 6513

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health