Class III includes devices with the greatest risk. Devices in this class must meet all of the requirements in Classes I and II. In addition, Class III devices cannot be marketed until they receive Premarket Approval.

The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and the other requirements described above. These devices require formal clinical studies to demonstrate safety and effectiveness. Under MDUFMA,Medical Device User Fee and Modernization Act of 2002, PMA applications (and supplemental premarket approval applications) are subject to significantly higher user fees than 510(k) applications, and they also require considerably more time and resources.

Rapid HIV tests intended for diagnostic use are regulated as Class III devices. Responsibility for assuring the safety and effectiveness of these tests lies within the Center for Biologics Evaluation and Research’s Office of Blood Research and Review, with oversight by the Blood Products Advisory Committee (BPAC).Committee. Approved Rapidrapid HIV tests must meet the regulations in the 21 CFR 800 series subparts, under the Investigational Deviceinvestigational device exemption, (IDE)or IDE and PMA pathways.

We manufacture, market and distribute three rapid HIV tests in the U.S: ourUnited States. Our HIV 1/2 STAT-PAK^® Assay, SURE CHECK^® HIV 1/2 Assay, and DPP^® HIV 1/2 Assay all of which have received FDA PMA approval. A PMA application must be submitted if a device cannot be cleared through the 510(k) process. A PMA application must be supported by extensive data including, but not limited to, analytical, preclinical, clinical trials, manufacturing, statutory preapproval inspections, and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use. Before a PMA is submitted, a manufacturer must apply for an investigational device exemption, or “IDE.”IDE. If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to file an IDE application with the FDA and obtain IDE approval prior to initiation of enrollment of human subjects for clinical trials. The IDE provides the manufacturer with a legal pathway to perform clinical trials on human subjects where without the IDE, only approved medical devices may be used on human subjects.

The IDE application must be supported by appropriate data, such as analytical, animal and laboratory testing results, manufacturing information, and an Investigational Review Board, (IRB)or IRB approved protocol showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. If the clinical trial design is deemed to have “non-significant risk,” the clinical trial may be eligible for “abbreviated” IDE requirements; and, inrequirements. In some instances, IVD clinical trials for in vitro diagnostic medical devices may be exempt from the more burdensome IDE requirements if certain labeling requirements are met.

A clinical trial may be suspended by either the FDA or the IRBInvestigational Review Board at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the study. Even if a study is completed, clinical testing results may not demonstrate the safety and efficacy of the device, or they may be equivocal or otherwise insufficient to obtain approval of the product being tested. After the clinical trials have been completed, if at all, and the clinical trial data and results are collected and organized, a manufacturer may complete a PMA application.

After a PMA application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information. By statute, the FDA has 180 days to review the “accepted application,” although, generally, review of the application can take between one and three years, but it may take significantly longer. During this review period, the FDA may request additional information or clarification of information already provided. Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The preapproval inspections conducted by the FDA include an evaluation of the manufacturing facility to ensure compliance with the Quality Systems Regulations (QSR),FDA’s quality systems regulations or QSR, as well as inspections of the clinical trial sites by the Bioresearch Monitoring group to evaluate compliance with good clinical practice and human subject protections. New PMA applications or PMA supplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device’s indication for use, manufacturing process, labeling and design. Significant changes to an approved PMA require a 180-day supplement, whereas less substantive changes may utilize a 30-day notice, or a 135-day supplement. Premarket approval supplements often require submission of the same type of information as a premarket approval application, except that the supplement is limited to information needed to support any changes from the device covered by the original premarket approval application, and it may not require as extensive clinical data or the convening of an advisory panel.

Our HIV 1/2 STAT-PAK^® Assay PMA application number BP050009/0 and our SURE CHECK^® 1/2 HIV Assay PMA application number BP050010/0 were approved by the FDA onin May 25, 2006. Our DPP^® HIV 1/2 Assay PMA application number BP120032/0 was approved by the FDA onin December 19, 2012.  Our DPP HIV Syphilis Assay PMA application number BP180191/0 was approved by the FDA in October 2020.

We do not currently market, distribute, or sell a product that has market clearance by the FDA. However, we are currently developing products that either will or are likely to require an FDA 510(k) clearance, and weclearance. We anticipate submitting a 510(k) for each such product to demonstrate that such proposed device is substantially equivalent to a respective previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of a 510(k).  FDA'sThe FDA’s 510(k) clearance pathway usually takes from three to twelve months but could take longer. In some cases the FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

If a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, a PMA. The FDA requires each device manufacturer to determine whether the proposed change requires submission of a new 510(k) or a PMA, but the FDA can review any such decision and, can disagree with a manufacturer’s determination. If the FDAif it disagrees with athe manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA of the modified device is obtained.

A manufacturer of a test categorized as moderately complex may request that categorization of the test asbe waived through a CLIA Waiver by Application, (CW)or CW, submission to the FDA. When a test is categorized as waived, it may be performed by laboratories with a Certificate of Waiver, such as a physician’s office outreach setting. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver 42 U.S.C. 263a(d)(3). Congress passed CLIA, in 1988, which provideda walk-in clinic or an emergency room provides CMS authority over all laboratory testing, except research that is performed on humans in the United States. The Division of Laboratory Services, within the Survey and Certification Group under the CMS, has the responsibility for implementing the CLIA program.

A formal request to issue an EUA generally should not be submitted until the Secretary of HHS has issued an EUA declaration under section 564(b)(1). In particular, although section 564 allows FDA to issue an EUA for preparedness purposes, in such cases the HHS Secretary must first declare that circumstances exist justifying such an authorization in advance of an actual emergency based on October 22, 2007. In 2008a formal determination of a significant potential for emergency or a material threat determination. During the effective period of the HHS Secretary’s EUA declaration, FDA revised its CLIA waiver requirements somay authorize the introduction of a medical product into interstate commerce when the product is intended for use during an actual or potential emergency. EUA candidate products include medical products and uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C Act or section 351 of the PHS Act.

After the requisite determination and declaration have been issued, and after feasible and appropriate consultations, FDA may issue an additional prospective trial is required in order to demonstrate clinical utility by showingEUA only if FDA concludes that the device is capablefollowing four statutory criteria for issuance have been met for 1) Serious or Life-Threatening Disease or conditions, 2) evidence of identifying new infections when used by untrained users. Our DPP^® HIV 1/2 test received a CLIA waivereffectiveness, 2) Risk –Benefit Analysis, 4) No Alternatives.  A sponsor seeking an EUA can submit its formal request in the form of an EUA submission, which includes data for clinical studies, non-clinical laboratory studies to assess the safety and effectiveness of the product as well as the discussion of Risks and Benefits of the product.

FDA will specify the effective date of an EUA issued under these newer requirementssection 564. In general, an EUA will remain in effect for the duration of the EUA declaration under which it was issued which describes termination of an EUA declaration and its impact on October 29, 2014.existing EUAs.

A host of regulatory requirements apply to our approved devices, includingincluding: the quality system regulation, (whichwhich requires manufacturers to follow elaborate design, testing, control, documentation and other quality assurance procedures),procedures; the Medical Reporting Regulations, (MDR) regulations (whichwhich require that manufacturers to report to the FDA specified types of adverse events involving their products),products; labeling regulations,regulations; and the FDA’s general prohibition against promoting products for unapproved or “off-label” uses. Some Class II devices also can haveare subject to special controls suchcontrols-such as performance standards, post-market surveillance, patient registries, and FDA guidelines thatguidelines-that do not apply to Class I devices.

The regulatory requirements that apply to our approved products classified as medical devices or IVDs includes:

Our Medford, New York facility is currently registered as an establishment with the FDA. We and any third-party manufacturers are subject to announced and unannounced inspections by the FDA to determine our compliance with quality system regulationQSR and other regulations.

The 21st Century Cures Act, enacted in December 2016, contains several sections specific to medical device innovations. The Company believesWe believe that implementation of the 21st Century Cures Act may have a positive impact on its businesses by facilitating innovation and/or reducing the regulatory burden imposed on medical device manufacturers.

We currently sell, market, or distributeoffer two veterinary devices in the United States: DPP®DPP VetTB Assay for Cervids and DPP®DPP VetTB Assay for Elephants. Diagnostic tests for animal health infectious diseases, including our veterinary devices for the prevention and/or treatment of animal disease, are regulated in the U.S. by the Center for Veterinary Biologics within the United StatesU.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service, (APHIS)or APHIS, under the Virus, Serum, and Toxin Act of 1913. As a requirement, our veterinary devices were approved by APHIS before they could be sold in the U.S.

The APHIS regulatory approval process involves the submission of product performance data and manufacturing documentation. Following regulatory approval to market a product, APHIS requires that each lot of product be submitted for review before release to customers. In addition, APHIS requires special approval to market products where test results are used in part for government-mandated disease management programs.

We have obtained patent coverage on our DPP^® technology, including numerous patents in the United States, and one or more patents in Australia, Brazil, Canada, China, Columbia, Eurasia (Russia), European Union (fourteen European countries),Hong Kong, Israel, India, Indonesia, Japan, Korea, Malaysia, Eurasia, Mexico, Poland, Singapore, Japan, Australia, Indonesia, KoreaSouth Africa, Thailand, and the U.K.United Kingdom .  Additional patent applications on our DPP^® technology are pending in the U.S.,United States, as well as in  many foreign countries such as Australia, Brazil, Canada, China, the European Union, India, Israel,Indonesia, Malaysia, Mexico, Peru, Singapore and South Africa. Thailand.

The DPP^® technology provides us with our own intellectual property. We believe it provides us with freedom to operate whichand enables us to develop tests with better performance and unmatched capabilities compared with tests built on traditional lateral flow platforms.  These advantages have allowed us to enter into multiple technology collaborations based upon the DPP^® technology, which we believe will provide new manufacturing and marketing opportunities. We have filed otheradditional patent applications that we believe will strengthen the DPP^® intellectual property and have also filed for patent protection for certain other point-of-care technologies or applications thereof.

We have filed and obtained trademarks for our company name CHEMBIO and CHEMBIO DIAGNOSTIC SYSTEMS, INC. as well as for many of our products, including DPP,^®, SURE CHECK,^®, STAT-VIEW,^®, STAT-PAK, and STAT-PAK^®,NEXT GENERATION DPP, as well as for the SampleTainer^®, and DPP Micro Reader, which isare used with certain DPP^® products.  Our trademarks have been obtainedregistered in the United States and certain other countries around the world.

We have developed a substantial body of trade secrets and know-how relating to the development and manufacture of lateral flow and DPP^®-basedDPP-based diagnostic tests, including but not limited to the sourcing and optimization of materials for such tests, and methods to maximize sensitivity, speed-to-result, specificity, stability and reproducibility of our tests.  We possess proprietary know-how to develop tests for multiple conditions using colored particles.  Our formulations enable long shelf lives of our rapid HIV and other tests, providing us with an important competitive advantage.

The peptides used in our rapid HIV tests were licensed to us by one or more third parties. We also have licensed the antigens used in other tests including our Syphilis, Tuberculosis, Leptospirosis, Leishmaniasis and Chagas tests, and we may enter into other license agreements.  In prior years, we concluded license agreements related to intellectual property rights owned by the United States associated with HIV-1 and during the first quarter of 2008, we entered into a sub-license agreement for HIV-2 with Bio-Rad Laboratories N.A., the exclusive licensee of the Pasteur Institute'sInstitute’s HIV-2 intellectual property estate.

We are a Nevada corporation that was formed in December 1985. Since inception, we have been involved in developing, manufacturing, sellingrequired to file annual, quarterly and distributing medical diagnostic tests, including rapid tests that detect a number of diseasescurrent reports, proxy statements and other conditions in humansinformation with the U.S. Securities and animals.
Exchange Commission. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

Investors should note that we currently announce material information to our investors and others using filings with the SEC, press releases, public conference calls, webcasts or our website (www.chembio.com), including news and announcements regarding our financial performance, key personnel, our brands and our business strategy. Information that we post on our corporate website could be deemed material to investors. We encourage investors to review the information we post on these channels. We may from time to time update the list of which would result in any person having Combined Ownership of 20% or more of the outstanding shares of the Common Stock, or (B) if such a tender or exchange offer has been published, announced, sent or given before the date of the Rights Agreement, then the close of business on the tenth business day after the date the Rights Agreement was entered into (or such later date as maychannels we will use to communicate information that could be determined by action of the Board of Directors prior to such time as any person becomes an Acquiring Person); (the earlier of such dates referred to in (i)deemed material and (ii), which date may includewill post information about any such date thatchange on www.chembio.com. The information on our website is afternot, and shall not be deemed to be, a part hereof or incorporated into this or any of our other filings with the dateSEC.

Our principal executive offices are located at 555 Wireless Boulevard, Hauppauge, New York 11788. Our telephone number is (631) 924-1135. Our website address is www.chembio.com. The information contained in, or accessible through, our corporate website does not constitute part of the Rights Agreement but prior to the issuance of the Rights, being called the "Distribution Date").this report.