Company: ADPT
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030913
Chunk: 94

Company: Adaptive Biotechnologies Corp
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 94
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 recall to reduce a health risk, this could lead to increased scrutiny by the FDA, other governmental and regulatory enforcement bodies, and our or our collaborators’ customers regarding the quality and safety of our products and services, and to negative publicity, including FDA alerts, press releases, or administrative or judicial actions. Furthermore, the submission of these reports could be used against us by competitors and cause customers to delay purchase decisions or cancel orders, which would harm our reputation. 

Any additional commercialized products or any future products that obtain regulatory clearance, authorization, approval, accreditation or licensure will remain subject to regulatory scrutiny and our failure to maintain our regulatory clearances, authorizations, approvals, accreditations or licensures could adversely affect our reputation, business and results of operations. 

Even if we or our collaborators obtain regulatory clearance, authorization, approval, accreditation or licensure in a jurisdiction for our products and services, the applicable regulatory authority may still impose significant restrictions on the indicated uses or marketing of our products and services, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance of our or our collaborators’ manufacturing and distribution. Advertising for certain devices and labeling, including promotional labeling, for all devices must comply with FDA requirements. In addition, device advertising and promotion may also be subject to other federal and state laws. For example, the FDA shares jurisdiction over the regulation of device advertising with the FTC. Advertising for devices characterized as restricted by the FDA is subject to specified FDA requirements, while advertising for non-restricted devices is regulated by the FTC. 

If we or our collaborators fail to comply with applicable regulatory requirements following clearance, authorization, approval, accreditation or licensure of any of our products and services, a regulatory agency may: 

•initiate an inspection of our or our collaborators’ facilities; 

•issue an untitled or warning letter asserting that we or our collaborators are in violation of law; 

•seek an injunction or impose civil or criminal penalties or monetary fines; 

•suspend or withdraw regulatory clearance, authorization or approval, or revoke a license or accreditation; 

•suspend any ongoing clinical studies; 

•delay or refuse clearance, authorization or approval of a pending regulatory submission or supplement submitted by us or our collaborators; 

•impose restrictions on our or our collaborators’ cleared, authorized, approved, accredited or licensed products or services; 

•seize or recall the product or service; 

•partially suspend or entirely shut down our or our collaborators’ manufacturing or laboratory operations; 

•issue advisories or other field actions