Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems

Published 06 Oct 2026, 11:42 UTC. Updated 06 Oct 2026, 13:02 UTC.

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Directly affected

No company is named in this report.

Indirectly affected

ATYR ATYR PHARMA INC COM NEW
GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
GEHC GE HEALTHCARE TECHNOLOGIES I
GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
ACHC ACADIA HEALTHCARE COMPANY INC
GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
ASND ASCENDIS PHARMA A/S
GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
BBIO BRIDGEBIO PHARMA INC
GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
DVA DaVita HealthCare Partners, Inc.
GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.

Price reaction, T-5 to T+3

Ticker	T-5	T-3	T-1	T0	T+1	T+2	T+3
ATYR	—	—	—	—	—	—	—
GEHC	—	—	—	—	—	—	—
ACHC	—	—	—	—	—	—	—
ASND	—	—	—	—	—	—	—
BBIO	—	—	—	—	—	—	—
DVA	—	—	—	—	—	—	—

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitatio…

Source: Federal Register

Price since this story was published: aTYR PHARMA (ATYR)

Since the first closing price after “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems,” aTYR PHARMA (ATYR) is -39.54%. The S&P 500 fund (SPY) is -1.36% over the same days, a -38.18% difference versus the market.

ATYR

SPY

Official trades in aTYR PHARMA (ATYR) around 6 Oct 2026

Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).

Who gains and who loses around aTYR PHARMA (ATYR)

Companies mentioned with this story

ATYR aTYR PHARMA
In “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems,” aTYR PHARMA (ATYR) is linked, with no stored direction, medium confidence. Reason on file: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
GEHC GE HealthCare Technologies
GE HealthCare Technologies (GEHC) is linked, with no stored direction, medium confidence in the 6 Oct 2026 story “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems.” Reason on file: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
ACHC Acadia Healthcare
In “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems,” Acadia Healthcare (ACHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
ASND Ascendis Pharma A/S
In “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems,” Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence. Reason on file: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
BBIO BridgeBio Pharma
For “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems,” BridgeBio Pharma (BBIO) is linked, with no stored direction, medium confidence. Reason on file: GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
DVA Davita
Davita (DVA) is linked, with no stored direction, medium confidence in the 6 Oct 2026 story “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems.” Reason on file: GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

aTYR PHARMA (ATYR)

The 6 Oct 2026 story “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems” names aTYR PHARMA (ATYR) because of this story.

The link for aTYR PHARMA (ATYR) is this: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

A second company, GE HealthCare Technologies (GEHC), is listed for a different reason: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

Price levels for aTYR PHARMA (ATYR)

ACHC traded between 26.75 and 32.03 across 20 sessions. The latest close on file is 30.20. ATYR traded between 0.17 and 0.41 across 20 sessions. The latest close on file is 0.17. GEHC traded between 63.33 and 71.29 across 20 sessions. The latest close on file is 69.76.

What the saved facts support for aTYR PHARMA (ATYR)

54 out of 100

“Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.