Press Release
☷FDA Roundup April 29 2022
Food and Drug Administration ( By Press Release office)
Apr 29,2022
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For Immediate Release: April 29 , 2022 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 On Thursday , the FDA announced the availability of a draft guidance for industry entitled The Accredited Third - Party Certification Program: Questions and Answers: Guidance for Industry .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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