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This Subcontract opportunity from Department Of Veterans Affairs was posted on July 11, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

FDA Regulatory Compliance & Technical Documentation Support

Closed
Federal

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The contract requires comprehensive regulatory strategy and technical documentation support for Class II medical device components, including preparation and submission assistance to the FDA, development of labeling compliant with U.S. regulations, and ongoing maintenance of technical files to ensure continuous regulatory alignment. The scope encompasses end-to-end regulatory activities needed to meet FDA requirements, with emphasis on accurate and up-to-date documentation that supports device clearance and market sustainability. All deliverables must adhere to current regulatory expectations and be executed with precision to avoid non-compliance risks. The contract is issued under the NAICS code 541690 as a subcontract by the Department of Veterans Affairs through the 262-NETWORK Contract Office 22 and is performance-based in Long Beach, California, with the response deadline set for July 15, 2026. The work supports critical medical device programs and requires deep expertise in FDA regulatory pathways, labeling standards, and technical file management. Subcontractors must demonstrate proven experience in supporting Class II medical devices and maintaining compliance through dynamic regulatory environments.

General Info

Class II medical device regulatory support for FDA submission, labeling, and technical file maintenance under VA subcontract in Long Beach.

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Long Beach, AZ, 90822-5201

Set-Aside

NONE

Documents

This scope was carved out of 36C26226Q1135.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

6515--VASER LIPOSUCTION

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 262-NETWORK Contract Office 22 (36C262)
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide regulatory strategy, FDA submission support, labeling compliance, and technical file maintenance for Class II medical device components.

More opportunities from Department Of Veterans Affairs → 262-NETWORK Contract Office 22 (36C262)

Same awarding agency

NAICS: 561720
New
Federal
S201--SEMI-ANNUAL WINDOW CLEANING
Solicitation # 36C26227Q0081
The Department of Veterans Affairs is soliciting quotes for a firm-fixed-price contract to provide semi-annual interior and exterior window, metal panel, and screen cleaning services at the VA Healthcare System in San Diego, California. The scope of work covers four specific buildings: Building 1 (six stories including atrium), Building 11 (two stories), Building 26 (five stories), and Building 27 (three stories). The contractor is responsible for providing all labor, equipment, and supplies, noting that most buildings lack roof anchors and require contractor-provided access equipment. The performance period consists of a base year from December 14, 2026, to December 13, 2027, with four subsequent one-year option periods. Each semi-annual cleaning cycle is estimated to take between 7 and 14 days to complete. This opportunity is set aside for Service-Disabled Veteran Owned Small Businesses (SDVOSB), with a requirement that the prime contractor does not subcontract more than 50 percent of the work to non-SDVOSB or non-VOSB firms. Award decisions will be based on a comparative best-value evaluation considering technical approach, price, and past performance, rather than the lowest price technically acceptable method. Offerors must comply with OSHA and California Code of Regulations safety standards and maintain specific insurance coverages, including general liability of 500,000 dollars per occurrence and automobile liability. Personnel are subject to background investigations and fitness determinations per VA directives. Proposals must be submitted as separate redacted and unredacted PDF files by December 7, 2026.
Janitorial Services

POSTED

about 9 hours ago

DEADLINE

in 25 days
View Details

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