The swiftness with which this virus was isolated was seen once again during the current pandemic. Scientists isolated SARS-CoV-2 and mapped the entire genome of the virus in mere days of it being declared responsible for a swathe of pneumonia cases in Wuhan, China. But although sequencing the genome of pathogens is crucial for the development of specific diagnostic tests and the identification of potential treatment options, it was legislation put into place in response to the 2001 terrorist attacks on US soil that gave rise to the Emergency Use Authorisation framework. This allowed those tests and treatments to proliferate – at least in the US. The Emergency Use Authorisation (EUA) authority allows the FDA to help strengthen US public health protections against chemical, biological, radiological, and nuclear (CBRN) threats – including infectious diseases – by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. An EUA does not represent approval of a drug or device in the full statutory meaning of the term, but instead authorises use of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency. The increased flexibility and fast-tracking of tests to the public have had a significant impact on the development of new technologies, as well as facilitating the speedy manufacture and supply of personal protective equipment (PPE) and medical devices to where they are needed.
Regulations governing the movement of goods for the diagnosis, treatment and management of Covid-19 may have been relaxed. But the regulatory aspects in relation to quality, efficacy and safety of products are stringently maintained, as their relaxation could ultimately lead to higher numbers of deaths. Another example of this is the temporary authorisation given in the UK under Human Medicines Regulations Section 174. This section permits the supply of identified vaccine batches based on the safety, quality and efficacy data submitted to the MHRA, but the authorisations do not constitute a marketing authorisation, and under Regulation 174, certain requirements must be met.
Similarly to the US and UK, in Europe, regulators have been praised for how quickly they moved to ensure the volumes of ventilators, IVDs, PPE, and later vaccines, were adequate to manage Covid-19. In response to the outbreak, the European Commission temporarily allowed the marketing of non-CE marked personal respiratory protective equipment (and other personal protective equipment) through Commission
Medical Device Developments /
www.nsmedicaldevices.com MMI049_mdi
consultants.indd 1 04/10/2021 11:38
mdi Consultants, Inc. The Global Regulatory Experts
Over 44 years’ experience, assisting companies worldwide successfully enter and obtain approval to market in the United States, Europe and Canada.
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• Provide FDA Regulatory Strategies • FDA/QSR/cGMP & ISO Compliance • Pre-Sub/510(k)/DeNovo/PMA submissions (over 4,000 successful submissions) • MDSAP (Medical Device Single Audit Program) - quality system implementation and certifi cation audit preparation • On-site Third Party Audits for ISO/MDSAP/ Mock FDA Audits • Device 513(g) requests for classifi cation • Health Canada MDEL and MDL assistance • FDA CRISIS INTERVENTION – (dealing with FDA inspections, FDA-483 & warning letter responses and mediation)
• US Agent and Offi cial Correspondent services • FDA Electronic Device Facility Registration and Device Listing • FDA Electronic Drug Facility Registration and Drug Listing • FDA Electronic Food Establishment Registration • e-MDR (Medical Device Reporting) fi ling • Unique Device Identifi cation (UDI) assistance
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