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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the agency published a short questions and answers web page regarding the safety of eggs during highly pathogenic Avian Influenza outbreaks. The FDA recognizes that consumers and farmers may have questions over recent reports of Highly Pathogenic Avian Influenza (HPAI) outbreaks in the United States.
- On Thursday, the FDA announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. The final rule for Accredited Third-Party Certification (TPP) was issued in 2015 under the FDA Food Safety Modernization Act (FSMA) and establishes a voluntary program in which the FDA recognizes accreditation bodies that have the responsibility for accrediting third-party certification bodies. These certification bodies conduct food safety audits and certify that eligible foreign food entities and the food they produce, meet the applicable food safety requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations.
- On Thursday, the FDA issued a Letter to Health Care Providers to alert about the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction. Medtronic issued an Urgent Medical Device Correction to inform health care providers of the pump weld defect and is investigating to identify which HVAD pumps may be affected. As stated in the FDA’s June 2021 communication, the FDA does not recommend the elective removal of properly functioning systems at this time. Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients together on a case-by-case basis, considering the patient’s clinical status and surgical risks.
- On Thursday, the FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test.
The FDA also updated At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions:
- Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures or in the heat?
- How is the expiration date determined for an at-home COVID-19 diagnostic test?
- Can I use an FDA-authorized at-home COVID-19 diagnostic test that is expired
- Can the expiration date of an at-home COVID-19 diagnostic test be extended?
- How do I know if the expiration date of my at-home COVID-19 test has been extended? Where do I find the updated expiration date?
- On Wednesday, the FDA issued an updated guidance for industry entitled, “Compliance with Providing an Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs for Food Importers Regulation”. The updated guidance replaces the temporary policy put in place with the March 2018 guidance of the same name, by stating that beginning on July 24, 2022, the use of the entity identification code “UNK” will no longer be an option when filing an entry with U.S. Customs and Border Protection (CBP). The UFI currently recognized as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
- On Wednesday, the FDA issued a Letter to Health Care Providers to increase awareness about the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The FDA has received reports describing serious adverse events and deaths for these devices after airway obstruction and ventilation failure. At this time, the root cause and incidence rate of obstruction and ventilation failure with use of these devices is not known.
- On Wednesday, the FDA approved an expanded indication for the TransMedics Organ Care System (OCS) Heart System. This approval marks the first device indicated for the preservation of donation-after-circulatory-death (DCD) hearts in a warm, beating state. The OCS Heart System was previously indicated for the preservation of donation-after-brain-death (DBD) hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged static cold storage. This expanded indication was granted a breakthrough designation for its intent to provide more effective treatment of a life-threatening or irreversibly debilitating disease or condition. The limited availability of donor hearts can have a disparate impact across communities in the United States.
- On Wednesday, the FDA issued draft guidance to industry titled “Action Levels for Lead in Juice; Draft Guidance for Industry” providing action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends. These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods and advance our goals in the, “Closer to Zero action plan”. The FDA estimates establishing a 10 parts per billion (ppb) action level for lead in apple juice could result in as much as a 46% reduction in exposure to lead from apple juice in children. For all other fruit and vegetable juices, establishing an action level of 20 ppb is estimated to result in a 19% reduction in exposure to lead from these juices in children.
- On Tuesday, the FDA authorized a shelf-life extension for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine, supplied in multiple dose vials with purple caps. The authorization allows the frozen vials to be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. This extension was granted following a thorough review of data submitted by the manufacturer. The FDA previously authorized a shelf-life extension for the Tris/Sucrose formulation of the vaccine on April 13, 2022. A copy of the granting letter and extension of expiration date are posted on FDA’s website.
- COVID-19 testing updates:
- As of today, 433 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and 1 diagnostic breath test. There are 78 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 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 949 revisions to EUA authorizations
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