Industry UPDATE: NIOSH Requirements for N95 masks In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval Program is accepting and prioritizing applications received for new approvals and extension of approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) and new domestic respirator manufacturers/applicants. NIOSH considers domestic
As of January 1, 2021, the UK’s departure from the EU will begin. As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system. This calls for several changes to how medical devices
Information on this Pandemic – Immunity from Liability If you were not up to date on this, on March 17, 2020, the United States Department of Health and Human Services (“HHS”) published a Declaration in the Federal Register providing immunity from liability under state and federal law to certain individuals and entities using medical countermeasures
Industry update MDR postponement – handle with care! The proposal for a one -year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step in the process will be a sign-off by the European Council. This is rather a formality
Many of our clients want to understand what it will take to get a successful launch of your device. Here is some insight to what you should be looking for to assure you give your technology a chance of getting your market to notice. Medical marketing can be a daunting task. For the start-up to
The FDA has issued a total of 24 warning letters to the medical device industry for the fiscal year 2018. That is two WLs per month. WOW, that is AMAZING. With hundreds of inspections being conducted by the FDA, worldwide, such low number of warning letters would make one believe that the MEDICAL DEVICE industry
People rely on medical device ranging from simple contact lenses to sophisticated pacemakers to improve the health and quality of life and so expect them to be safe and incorporate the latest progress in science and innovation. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the European
Changes for the CE mark requirements. Supplied by mdi-Europa Below is a short summary of the most important changes that are coming our way with the new MDR. Some of these have been discussed before in our newsletters and / or mailings, however, the below article gives another complete overview: Liability: Insurance coverage for manufacturers
Industry Links The list below is meant to be a comprehensive list of important industry links that are helpful and useful for our clients. If you find a useful link that would be helpful to others, please email it to us (contact page), and we will try to include it on the list below. FDA
Insight Report Vol. 13 No.1 Prepared by: Aditya Sukthankar Background: A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and
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