# Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
Canonical URL: https://biopharmsignal.com/news/FEMY/femasys-announces-fembloc-permanent-birth-control-has-achieved-mdsap-certificati-116fbb03
Ticker: FEMY
Company: FEMASYS
Source: FEMASYS
Published: 2026-02-26 14:00 EST
## Summary

-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance --

ATLANTA, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today that its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its pivotal clinical trial toward PMA submission. Internationally, the certification enhances manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling more efficient market entry in additional high-value regions. Overall, MDSAP certification reduces regulatory risk, reinforces manufacturing readiness, and advances the Company’s global expansion strategy.

## Article Body
-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance --

ATLANTA, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today that its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its pivotal clinical trial toward PMA submission. Internationally, the certification enhances manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling more efficient market entry in additional high-value regions. Overall, MDSAP certification reduces regulatory risk, reinforces manufacturing readiness, and advances the Company’s global expansion strategy.
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- 2026-04-22 13:00 EST — [Femasys Launches FemaSeed® Complete for OB/GYNs at ACOG 2026](https://biopharmsignal.com/news/FEMY/femasys-launches-femaseed-complete-for-ob-gyns-at-acog-2026-df2f274c) — Source: FEMASYS
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