- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA announced its recognition of JANAAC as an Accreditation Body Under FSMA- Accredited Third Party Certification Program for a period of five years. Accreditation bodies recognized by the FDA have the authority to accredit third-party certification bodies. Once accredited, the certification bodies can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods – both human and animal – that they produce. These certifications may be used in certain specific circumstances where the FDA can require that imported products be certified before entering the United States, and are required for importers to establish eligibility for participation in the Voluntary Qualified Importer Program.
- On June 21, the FDA announced it will convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed. The FDA continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. Further details concerning the agenda, timing and location of the Advisory Committee meeting will be announced in the coming weeks.
- COVID-19 testing updates:
- As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1011 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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