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Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
****!!!!**** "Notice to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement in section 510(k) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this notice, the Department is immediately making permanent the exemption of 7 class I device classes from the section 510(k) requirement and proposes to exempt an additional 84 class II and unclassified device classes from the same requirement on a permanent basis. These 91 devices were all subject a 510(k) waiving during the PHE."
#Emergency#Pandemic Control
·federalregister.gov·
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
GUIDANCE TO REGISTRANTS: PROCESS FOR MAKING CLAIMS AGAINST Emerging Viral Pathogens NOT ON EPA-REGISTERED DISINFECTANT LABELS ~EPA
GUIDANCE TO REGISTRANTS: PROCESS FOR MAKING CLAIMS AGAINST Emerging Viral Pathogens NOT ON EPA-REGISTERED DISINFECTANT LABELS ~EPA
****** "A product should be approved by EPA to inactivate at least one large or one small non-enveloped virus to be eligible for use against an enveloped emerging viral pathogen." "viral families in the ***small non-enveloped subgroup: (1) Picornaviridae, (2) Parvoviridae, (3) Caliciviridae, (4) Astroviridae, and (5) Polyomaviridae.... ***large non-enveloped subgroup: (1) Adenoviridae, (2) Reoviridae, and (3) Papillomaviridae... ***enveloped subgroup: (1) Arenaviridae, (2)Bornaviridae, (3) Bunyaviridae, (4) Coronaviridae, (5) Filoviridae, (6) Flaviviridae, (7) Hepadnaviridae, (8) Herpesviridae, (9) Orthomyxoviridae, (10) Paramyxoviridae, (11) Poxviridae, (12) Retroviridae, (13) Rhabdoviridae, and (14) Togaviriedae."
#Emergency#Pandemic Control#Registration & Regulation
·epa.gov·
GUIDANCE TO REGISTRANTS: PROCESS FOR MAKING CLAIMS AGAINST Emerging Viral Pathogens NOT ON EPA-REGISTERED DISINFECTANT LABELS ~EPA
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19 | FDA
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19 | FDA
There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.
#Emergency#Pandemic Control#Registration & Regulation#COVID & other Diseases
·fda.gov·
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19 | FDA
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
****!!!!****!!!!**** {510(k) exemptions for COVID.} "FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices." "Medical devices disinfectors... exempt from premarket review." "during the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) [and some other requirements]. FDA believes such devices will not create such an undue risk where the performance and labeling elements... are met." "If the device generates ozone, FDA recommends that the manufacturer evaluate whether the product is within the maximum acceptable level of ozone given in 21 CFR 801.415." [****It sounds like chlorine dioxide could be used if stays below regulated air levels. FDA has endorsed ClO2 standards for air related to food processing [ but need to check FDA's approved air concentrations for around people]. EPA has approved safety of air concentrations at specific levels around people.****]
#Emergency#Air#nb1#Pandemic Control#mj1#Registration & Regulation#Accessories & Equipment
·fda.gov·
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
COVID-19 Control and Prevention ~OSHA
COVID-19 Control and Prevention ~OSHA
Employers are responsible for complying with PPE standards, including Respiratory Protection. However, OSHA is providing temporary enforcement flexibility. Webpage also includes Guidance, including for specific types of worker groups.
#Air#Emergency#Pandemic Control
·www.osha.gov·
COVID-19 Control and Prevention ~OSHA