Date of Decision: October 6, 2022
Service Center: Texas Service Center
Form Type: Form I-140
Case Type: EB-2 National Interest Waiver (NIW)
Field of Expertise: Medical Device Technology
Petitioner Information
Profession: Entrepreneur
Field: Medical Device Technology
Nationality: Not specified
Summary of Decision
Initial Decision: Denied
Appeal Outcome: Remanded
Evidentiary Criteria Analysis
Criteria Met:
The petitioner provided evidence of founding a company in the medical device industry and overseeing its operations.
The petitioner submitted documentation indicating expertise in developing hardware and software technologies for medical equipment.
Criteria Not Met:
The evidence provided at the time of filing did not establish the petitioner’s eligibility for the requested benefit.
The petitioner’s proposed endeavor did not meet the national importance element of the Dhanasar framework.
Key Points from the Decision
Proposed Endeavor:
The petitioner plans to continue using his expertise and knowledge in the medical device industry to work as an entrepreneur in the United States. He intends to develop and manufacture medical equipment hardware and software, provide maintenance and calibration services, and offer medical data analytics for healthcare research.
Substantial Merit and National Importance:
The petitioner’s proposed endeavor has substantial merit in the healthcare and biotechnology sectors. However, the evidence submitted did not demonstrate national importance at the time of filing. The endeavor’s impact on the national level was not sufficiently established.
Supporting Evidence:
The petitioner submitted a signed statement, company registration documents, development plans for medical equipment, and descriptions of software and hardware technologies. The evidence provided was not sufficient to establish the proposed endeavor’s national importance.
Inconsistencies in Proposed Endeavor:
The petitioner formed the company after the initial petition filing, which does not assist in establishing eligibility at the time of filing. The Director’s decision did not adequately address the evidence submitted with the petition or in response to the request for evidence (RFE).
Supporting Documentation
Letters of Intent: Not applicable.
Business Plan: The petitioner submitted a business plan outlining the development and manufacturing of medical equipment and software.
Advisory Letter: Not applicable.
Any other supporting documentation: Company registration documents and descriptions of planned activities were provided but were insufficient to meet the evidentiary requirements.
Conclusion
Final Determination: Remanded
Reasoning:
The Director’s decision is withdrawn, and the matter is remanded for further proceedings. The Director must consider whether the petitioner satisfies the eligibility requirements for classification as a member of the professions holding an advanced degree or as an individual of exceptional ability. Additionally, the Director should properly apply all three prongs of the Dhanasar analytical framework to determine if a waiver of the job offer requirement would be in the national interest.
