remanded EB-2 NIW Case: Medical Device Industry

U.S. Citizenship 
and Immigration 
Services 
In Re: 22642819 
Appeal of Texas Service Center Decision 
Non-Precedent Decision of the 
Administrative Appeals Office 
Date: OCT. 6, 2022 
Form 1-140, Immigrant Petition for Alien Worker (Advanced Degree, Exceptional Ability, National 
Interest Waiver) 
The Petitioner, an entrepreneur in the medical device industry, seeks second preference immigrant 
classification as a member of the professions holding an advanced degree and as an individual of 
exceptional ability, as well as a national interest waiver of the job offer requirement attached to this 
EB-2 classification. See Immigration and Nationality Act (the Act) section 203(b)(2), 8 U.S.C. 
§ 1153(b )(2). 
The Director of the Texas Service Center denied the petition, concluding that the Petitioner had not 
established that a waiver of the required job offer, and thus of the labor certification, would be in the 
national interest. On appeal, the Petitioner submits additional documentation and a brief asserting that 
he is eligible for a national interest waiver. In these proceedings, it is the petitioner's burden to 
establish eligibility for the immigration benefit sought. Section 291 of the Act, 8 U.S.C. § 1361. Upon 
de nova review, we will withdraw the Director's decision and remand the matter for further review of 
the record and issuance of a new decision. 
I. LAW 
To establish eligibility for a national interest waiver, a petitioner must first demonstrate qualification 
for the underlying EB-2 visa classification, as either an advanced degree professional or an individual 
of exceptional ability in the sciences, arts, or business. Because this classification requires that the 
individual's services be sought by a U.S. employer, a separate showing is required to establish that a 
waiver of the job offer requirement is in the national interest. 
Section 203(b) of the Act sets out this sequential framework: 
(2) Aliens who are members of the professions holding advanced degrees or aliens of 
exceptional ability. -
(A) In general. - Visas shall be made available ... to qualified immigrants who are 
members of the professions holding advanced degrees or their equivalent or 
who because of their exceptional ability in the sciences, arts, or business, will 
substantially benefit prospectively the national economy, cultural or 
educational interests, or welfare of the United States, and whose services in the 
sciences, arts, professions, or business are sought by an employer in the United 
States. 
(B) Waiver ofjob offer-
(i) National interest waiver. ... [T]he Attorney General may, when the Attorney 
General deems it to be in the national interest, waive the requirements of 
subparagraph (A) that an alien's services in the sciences, arts, professions, or 
business be sought by an employer in the United States. 
Section 10l(a)(32) of the Act provides that "[t]he term 'profession' shall include but not be limited to 
architects, engineers, lawyers, physicians, surgeons, and teachers in elementary or secondary schools, 
colleges, academics, or seminaries." 
The regulation at 8 C.F.R. § 204.5(k)(2) contains the following relevant definitions: 
Advanced degree means any United States academic or professional degree or a foreign 
equivalent degree above that of baccalaureate. A United States baccalaureate degree 
or a foreign equivalent degree followed by at least five years of progressive experience 
in the specialty shall be considered the equivalent of a master's degree. If a doctoral 
degree is customarily required by the specialty, the alien must have a United States 
doctorate or a foreign equivalent degree. 
Exceptional ability in the sciences, arts, or business means a degree of expertise 
significantly above that ordinarily encountered in the sciences, arts, or business. 
Profession means one of the occupations listed in section 10l(a)(32) of the Act, as well 
as any occupation for which a United States baccalaureate degree or its foreign 
equivalent is the minimum requirement for entry in the occupation. 
In addition to the definition of "advanced degree" provided at 8 C.F.R. § 204.5(k)(2), the regulation 
at 8 C.F.R. § 204.5(k)(3)(i)(B) provides that a petitioner present "[a]n official academic record 
showing that the alien has a United States baccalaureate degree or a foreign equivalent degree, and 
evidence in the form ofletters from current or former employer(s) showing that the alien has at least 
five years of progressive post-baccalaureate experience in the specialty." 
Also, the regulation at 8 C.F.R. § 204.5(k)(3)(ii) sets forth the specific evidentiary requirements for 
demonstrating eligibility as an individual of exceptional ability. A petitioner must submit 
documentation that satisfies at least three of the six categories of evidence listed at 8 C.F.R. 
§ 204.5(k)(3)(ii). 
Furthermore, while neither the statute nor the pertinent regulations define the term "national interest," 
we set forth a framework for adjudicating national interest waiver petitions in the precedent decision 
Matter of Dhanasar, 26 I&N Dec. 884 (AAO 2016). Dhanasar states that after a petitioner has 
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established eligibility for EB-2 classification, U.S. Citizenship and Immigration Services (USCIS) 
may, as matter of discretion 1, grant a national interest waiver if the petitioner demonstrates: (1) that 
the foreign national's proposed endeavor has both substantial merit and national importance; (2) that 
the foreign national is well positioned to advance the proposed endeavor; and (3) that, on balance, it 
would be beneficial to the United States to waive the requirements of a job offer and thus of a labor 
certification. 
The first prong, substantial merit and national importance, focuses on the specific endeavor that the 
foreign national proposes to undertake. The endeavor's merit may be demonstrated in a range of areas 
such as business, entrepreneurialism, science, technology, culture, health, or education. In 
determining whether the proposed endeavor has national importance, we consider its potential 
prospective impact. 
The second prong shifts the focus from the proposed endeavor to the foreign national. To determine 
whether he or she is well positioned to advance the proposed endeavor, we consider factors including, 
but not limited to: the individual's education, skills, knowledge and record of success in related or 
similar efforts; a model or plan for future activities; any progress towards achieving the proposed 
endeavor; and the interest of potential customers, users, investors, or other relevant entities or 
individuals. 
The third prong requires the petitioner to demonstrate that, on balance, it would be beneficial to the 
United States to waive the requirements of a job offer and thus of a labor certification. In performing 
this analysis, USCIS may evaluate factors such as: whether, in light of the nature of the foreign 
national's qualifications or the proposed endeavor, it would be impractical either for the foreign 
national to secure a job offer or for the petitioner to obtain a labor certification; whether, even assuming 
that other qualified U.S. workers are available, the United States would still benefit from the foreign 
national's contributions; and whether the national interest in the foreign national's contributions is 
sufficiently urgent to warrant forgoing the labor certification process. In each case, the factor(s) 
considered must, taken together, indicate that on balance, it would be beneficial to the United States 
to waive the requirements of a job offer and thus of a labor certification. 2 
II. ANALYSIS 
A. Member of the Professions Holding an Advanced Degree 
In denying the petition, the Director did not address the Petitioner's eligibility for classification as a 
member of the professions holding an advanced degree. To qualify as a member of the professions, 
an individual must meet "one of the occupations listed in section 101(a)(32) of the Act, as well as any 
occupation for which a United States baccalaureate degree or its foreign equivalent is the minimum 
requirement for entry into the occupation." 8 C.F.R. 204.5(k)(2). 3 Further, in order to show an 
individual holds an advanced degree, the petition must be accompanied by "[a ]n official academic 
1 See also Poursina v. USCIS. No. 17-16579, 2019 WL 4051593 (Aug. 28, 2019) (finding USCTS' decision to grant or 
deny a national interest waiver to be discretionary in nature). 
2 See Dhanasar, 26 I&N Dec. at 888-91. for elaboration on these three prongs. 
3 Section 101 (a)(32) of the Act states "[t]he term 'profession' shall include but not limited to architects, engineers, lawyers, 
physicians, surgeons, and teachers in elementary or secondary schools, colleges, academics, or seminaries." 
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record showing that the alien has a United States advanced degree or a foreign equivalent degree." 
8 C.F.R. § 204.5(k)(3)(i)(A). Alternatively, the Petitioner may present "[a]n official academic record 
showing that the alien has a United States baccalaureate degree or a foreign equivalent degree, and 
evidence in the form of letters from current or former employer( s) showing that the alien has at least 
five years of progressive post-baccalaureate experience in the specialty." 8 C.F.R. § 204.5(k)(3)(i)(B). 
The Director's decision did not indicate whether the Petitioner's occupation, entrepreneur in the medical 
device industry, qualifies as a member of the professions. In addition, the Director did not conclude 
whether the Petitioner's "Titulo de Bacharel" degree from is a foreign 
equivalent of a U.S. baccalaureate degree followed by at least five years of progressive experience in the 
specialty. 
On remand, the Director should first determine whether the Petitioner's occupation as an entrepreneur 
is a member of the professions. If so, the Director should consider whether the Petitioner's 'Titulo de 
Bacharel" degree meets the foreign equivalent of a U.S. baccalaureate degree followed by at least five 
years of progressive experience in the specialty. If the Director concludes that the Petitioner is not an 
advanced degree professional, he should then determine whether the Petitioner qualifies as an 
individual of exceptional ability, discussed below. 
B. Exceptional Ability 
The Director's decision did not address the Petitioner's eligibility for classification as an individual of 
exceptional ability. 4 The Petitioner asserted eligibility and submitted documentation for five of the 
regulatory criteria under 8 C.F.R. § 204.5(k)(3)(ii)(A)-(F). 5 He also provided comparable evidence 
pursuant to the regulation at 8 C.F.R. § 204.5(k)(3)(iii). 
On remand, the Director should review the evidence and determine if the Petitioner has met three of the 
above initial regulatory criteria for classification as an individual of exceptional ability. If so, the Director 
should then conduct a final merits determination to conclude whether the Petitioner has achieved the level 
of expertise significantly above that ordinarily encountered for exceptional ability classification. 
C. National Interest Waiver 
The remaining issue to be determined is whether the Petitioner has established that a waiver of the 
requirement of a job offer, and thus a labor certification, would be in the national interest. With respect 
to his proposed endeavor, the Petitioner submitted a signed statement at the time of filing indicating that 
he intends "to continue using my expertise and knowledge as a businessman in the medical device 
4 A petitioner seeking classification as an individual of exceptional ability must present documentation that satisfies at 
least three of the six categories of initial evidence listed at 8 C.F.R. § 204.5(k)(3)(ii). However, meeting the minimum 
requirement by providing at least three types of initial evidence does not, in itself, establish that the Petitioner meets the 
requirements for exceptional ability classification. In the second part of the analysis, officers should evaluate the evidence 
together when considering the petition in its entirety for the final merits determination. The officer must determine whether 
or not the petitioner, by a preponderance of the evidence, has demonstrated that she has a degree of expertise significantly 
above that ordinarily encountered in the sciences, arts, or business. See 6 USCIS Policy Manual F.S(B), 
https://www.uscis.gov/policy-manual. 
5 The Petitioner did not claim eligibility for the license criterion under 8 C.F.R. § 204.5(k)(3)(ii)(C). 
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industry, particularly in the cleaning and sterilization of medical equipment, by working as an 
entrepreneur in the United States." He further stated: "The services I offer healthcare professionals 
provide the best quality care with the equipment they can count on is sterile and ready to use at a moment's 
notice." In addition, the Petitioner asserted: 
My career plan in the United States is to work with medical device companies, American 
clinics, and hospitals that require my specialized knowledge, years of experience, and 
significant have expertise. I intend to continue implementing ingenious strategies while 
maintaining positive relationships with my professional colleagues and identifying any 
opportunities for business . . . . In addition, my direct knowledge of the medical device 
industry in Brazil will be substantially beneficial to any U.S. health care company looking 
to form cross-border partnerships with companies in Brazil and throughout Latin 
America. 
1. Substantial Merit and National Importance of the Proposed Endeavor 
With regard to the first prong of Dhanasar, the Director issued a request for evidence (RFE) asking 
the Petitioner to provide further information and evidence regarding both the substantial merit and 
national importance of his proposed endeavor. In response, the Petitioner stated: 
Petitioner's endeavor is the creation of a healthcare and biotechnology company 
engaged in developing hardware and software technologies for medical equipment 
analysis and patient monitoring. Petitioner has founded, organized, and registered 
I I in the State of Florida and is engaged in overseeing: (1) 
development and manufacturing of medical equipment hardware; (2) development of 
computerized maintenance management system software utilizing artificial 
intelligence for automated dynamic adjustments to medical equipment during patient 
care; (3) maintenance and calibration services of medical equipment hardware; and (4) 
medical data analytics for healthcare research. Petitioner is the chief executive officer 
ofl land manages the operations of the company. 
The Petitioner's response included documents indicating that that he formedl I in 
January 2021. As the Petitioner's founding, organization, and registration ofl I 
materialized after the filing of the petition, and therefore would not establish his eligibility at the time 
of filing, it does not assist him in establishing that he meets the requirements set forth in the Dhanasar 
framework. The petition in this matter was filed on January 14, 2019, and the Petitioner has the burden 
of proof to establish eligibility for the requested benefit at the time of filing. See 8 C.F.R. 
§ 103.2(b)(l), (12); see also Matter of Katigbak, 14 I&N Dec. 45, 49 (Comm'r 1971) (providing that 
"Congress did not intend that a petition that was properly denied because the beneficiary was not at 
that time qualified be subsequently approved at a future date when the beneficiary may become 
qualified under a new set of facts"). Further, a petitioner may not make material changes to a petition 
in an effort to make a deficient petition conform to USCIS requirements. See Matter of Izummi, 22 
I&N Dec. 169, 176 (Assoc. Comm'r 1998). 
In denying the petition, the Director listed some of the Petitioner's documentation and stated that "[t]he 
evidence does not establish that the proposed endeavor is meritorious" and that the "endeavor does not 
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meet the national importance element of the first prong of the Dhanasar framework." The decision, 
however, did not contain a proper analysis of the Petitioner's evidence or a sufficient discussion 
explaining why the Petitioner had not demonstrated eligibility at the time of filing. See 8 C.F.R. 
§ 103.2(b)(l), (12). An officer must fully explain the reasons for denying a visa petition in order to 
allow the Petitioner a fair opportunity to contest the decision and to allow us an opportunity for 
meaningful appellate review. See 8 C.F.R. § 103.3(a)(l)(i); see also Matter of M-P-, 20 I&N Dec. 
786 (BIA 1994) (finding that a decision must fully explain the reasons for denial to allow the 
respondent a meaningful opportunity to challenge the determination on appeal). Here, the Director's 
decision did not adequately address the evidence submitted with the petition or in response to the RFE. 
The Director should analyze the Petitioner's evidence to determine if his proposed endeavor has both 
substantial merit and national importance. If the Director concludes that the Petitioner's 
documentation does not meet the requirements of Dhanasar' s first prong, his decision should discuss 
the insufficiencies in the evidence and adequately explain the reasons for ineligibility. 
2. Well Positioned to Advance the Proposed Endeavor 
Relating to Dhanasar' s second prong, the Director concluded that "[b ]ased on the evidence in the 
record, the Petitioner meets the prong." However, the decision did not identify the evidence and 
sufficiently explain the basis for this determination. 
3. Balancing Factors to Determine Waiver's Benefit to the United States 
With respect to prong three of the Dhanasar precedent decision, the Director's decision stated that the 
Petitioner's "lab documents, licensing agreements, and other company materials" had "not established 
that, on balance, it would be beneficial to the United States to waive the requirements of a job offer, 
and thus of a labor certification." The Director's decision, however, did not adequately address the 
Petitioner's arguments and evidence submitted at time of initial filing and in response to the RFE. 
Without a proper evaluation of the factors identified in Dhanasar's third prong, the Director's 
determination for this prong was in error. If the Director determines that the Petitioner's 
documentation does not meet this prong, his decision should address all of the Petitioner's arguments 
and evidence, and explain the relative decisional weight given to each balancing factor. 
III. CONCLUSION 
To meet the requirements for a national interest waiver, an individual must first qualify for the 
underlying EB-2 visa classification. We are therefore remanding the petition for the Director to 
consider whether the Petitioner has satisfied the eligibility requirements for classification as a member 
of the professions holding an advanced degree or as an individual of exceptional ability. In addition, 
the Director should properly apply all three prongs of the Dhanasar analytical framework to determine 
whether the Petitioner has established that a waiver of the requirement of a job offer, and thus a labor 
certification, would be in the national interest. As such, we will remand the matter for further 
consideration of the record (including the claims and documentation submitted on appeal), and entry 
of a new decision. The Director may request any additional evidence considered pertinent to the new 
decision. 
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ORDER: The decision of the Director is withdrawn. The matter is remanded for further 
proceedings consistent with the foregoing analysis and entry of a new decision. 
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