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FDA Roundup: January 25, 2022

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 issued two final guidances to provide recommendations for including patient perspectives in medical device clinical studies.  
    Patient Engagement in the Design and Conduct of Medical Device Clinical Studies 
    This final guidance: 
    • Describes how device developers, sponsors and industry can voluntarily use patient engagement to improve clinical study design and conduct. 
    • Provides examples of approaches to consider when device developers, sponsors and industry wish to incorporate patient advisor input in clinical studies.  
    • Describes which patient engagement activities are generally not considered by the FDA to constitute an activity subject to the FDA’s regulations regarding Institutional Review Boards (IRBs). 
    • Clarifies how sponsors can receive feedback from the FDA on plans to voluntarily include patient advisors’ input on their clinical study through the Q-submission process.

    Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation  
    This final guidance: 

    • Describes principles that may be considered for instruments that capture and measure patient-reported outcomes. 
    • Provides recommendations about the importance of ensuring these instruments are fit-for-purpose.
    • Outlines best practices for selecting, developing, modifying, or adapting a patient-reported outcome instrument for use in medical device evaluation 
  • Today, the FDA proposed a new rule to amend our regulation (21 CFR 170.105) on how and when the FDA may determine that a pre-market notification for a food contact substance (FCN) is no longer effective. Primarily, this rule would enable the FDA to determine that an FCN is no longer effective when the manufacturer discontinues its use based on reasons other than safety, for example, they no longer produce, supply, or use the food contact substance.  For more information, please see FDA Proposes New Rule to Revise Procedures and Update Reasons for Revoking the Authorizations for Food Contact Substances.
  • Today, the FDA posted an at-a-glance fact sheet for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF). The final rule establishes a laboratory accreditation program for the testing of food in certain circumstances. 
  • On Jan. 22, the FDA added the following frequently asked question to the COVID-19 Test FAQs: Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures?
  • On Jan. 21, the FDA updated the In Vitro Diagnostics EUAs – Molecular and Antigen Diagnostic Tests for SARS-CoV-2 web pages to share the latest information. The update added details about the design of SARS-CoV-2 diagnostic tests, including: 
    • Which authorized molecular and antigen diagnostic tests are designed with single or multiple viral targets.
    • Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants. Tests with multiple targets are more likely to continue to perform well when new variants emerge.
  • On Jan. 21, the FDA approved an abbreviated new drug application (ANDA 214297) for methylprednisolone acetate injectable suspension USP, 200 mg/5 mL (40 mg/mL), 400 mg/10 mL (40 mg/mL), and 400 mg/5 mL (80 mg/mL). It is identified as being in shortage on the FDA’s Drug Shortage List. Side effects of methylprednisolone acetate injectable suspension include allergic reaction, leukocytosis (increased white blood cell count), bradycardia (decreased heart rate), and acne. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
  • On Jan. 19, the FDA authorized another over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The emergency use authorization (EUA) of the MaximBio ClearDetect COVID-19 Antigen Home Test is another example of the FDA’s commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans. The MaximBio ClearDetect COVID-19 Antigen Home Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. 
    • The test can be used as: 
      • A single test for people with COVID-19 symptoms. 
      • A serial test for people without symptoms, meaning the test is done two times over three days. 
    • The test can be used for people:
      • Age 14 years or older with a self-collected nasal swab sample.
      • Age 2 years or older when an adult collects the nasal swab sample. 
  • COVID-19 testing updates:
    • As of today, 423 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 87 antibody and other immune response tests and 45 antigen tests. There are 69 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests. 
    • The FDA has authorized 25 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 783 revisions to EUA authorizations.

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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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