Changeflow GovPing Healthcare FDA Variance Approval Letter to Anthony Ritzko
Routine Guidance Added Final

FDA Variance Approval Letter to Anthony Ritzko

Favicon for www.regulations.gov Regs.gov: Food and Drug Administration
Published March 24th, 2025
Detected March 25th, 2026
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Summary

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Anthony Ritzko. The letter, dated March 24, 2025, is available in both redacted and unredacted forms.

What changed

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to an individual named Anthony Ritzko. The letter, dated March 24, 2025, indicates a specific approval related to a variance. While the exact nature of the variance is not detailed due to redactions for personally identifiable information, it pertains to medical device regulations.

Compliance officers should note this as an individual approval rather than a broad regulatory change. The availability of both redacted and unredacted versions suggests that the core approval details are public, but specific identifying information is protected. No immediate actions are required for entities other than the named recipient, but it serves as an example of the FDA's variance approval process for medical devices.

Source document (simplified)

Content

There are no documents available to view or download

Attachments 2

Variance Approval Letter from FDA CDRH to Anthony Ritzko

Restricted: Personally Identifiable Information

More Information
- Author(s) CDRH

Variance Approval Letter from FDA CDRH to Anthony Ritzko_Redacted

More Information
- Author(s) CDRH
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Classification

Agency
FDA
Published
March 24th, 2025
Instrument
Guidance
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2025-V-4992-0003
Docket
FDA-2025-V-4992

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Approval
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices

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