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FDA CDRH Denial Letter to Olsson Frank Weeda Terman Matz PC, Apr 22

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Summary

FDA CDRH issued a Final Response Letter on April 22 denying a regulatory petition (FDA-2015-P-2854) submitted by Olsson Frank Weeda Terman Matz PC. The denial letter constitutes a final agency action on the petitioned matter. The specific subject matter and basis for denial are contained in the attachment (Final Response Letter), which is available for download as a PDF.

“Final Response Letter from FDA CDRH to Olsson Frank Weeda Terman Matz PC”

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About this source

Every FDA document on regulations.gov, the federal rulemaking portal. This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot. Around 240 a month. FDA's heavy regulations.gov use means tracking only the Federal Register misses a meaningful chunk of what the agency does day-to-day. Watch this if you manufacture devices, submit IND or NDA applications, run a lab, or advise sponsors on FDA process. GovPing publishes each posting with the docket, document type, division (CDER, CDRH, CFSAN), and comment window where one applies.

What changed

FDA CDRH issued a final denial letter on April 22 to Olsson Frank Weeda Terman Matz PC regarding petition FDA-2015-P-2854. The denial constitutes final agency action on the petitioned regulatory matter. Affected parties who submitted the petition or have analogous matters pending before CDRH should review the denial letter's reasoning, available as an attachment, to determine whether further administrative or judicial review is warranted. Petitioners seeking regulatory relief through CDRH should be aware that a denial of this nature signals finality on the specific request unless challenged through available appeal mechanisms.

Archived snapshot

Apr 23, 2026

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Content

There are no documents available to view or download

Attachments 1

Final Response Letter from FDA CDRH to Olsson Frank Weeda Terman Matz PC

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA CDRH
Filed
April 22nd, 2025
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive
Docket
FDA-2015-P-2854

Who this affects

Applies to
Medical device makers Legal professionals
Industry sector
3345 Medical Device Manufacturing
Activity scope
Regulatory petition response Administrative denial
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Pharmaceuticals Healthcare

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