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FDA launches Experimental Learning Program

March 30, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration is rolling out a new program whereby regulatory staff learn about new and innovative medical device technologies from industry to enhance premarket reviews and other regulatory processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]

Filed Under: Food & Drug Administration (FDA) Tagged With: blog, Emergo Group

New clinical guidelines for medical devices from Australian TGA

March 29, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

New medical device rules change India’s Authorized Agent role

March 28, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

This is not a test: RMAT designation goes live

March 27, 2017 By Danielle Kirsh

FDA

By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds […]

Filed Under: Food & Drug Administration (FDA) Tagged With: blog, FDA Voice

Little or no audit preparation common device QMS problem

March 24, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. Get the full story here at the Emergo Group’s blog. The […]

Filed Under: Policy Tagged With: blog, Emergo Group

Trump proposes higher FDA fees for drug, medical device FDA registrants

March 23, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]

Filed Under: Food & Drug Administration (FDA) Tagged With: blog, Emergo Group

Medical device firms have little understanding of European MDR, IVDR

March 22, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

Malaysia plans to ratify ASEAN Medical Device Directive

March 21, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or […]

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

510(k) submissions to FDA declining

March 17, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased. Get the full story here at the Emergo Group’s blog. […]

Filed Under: Food & Drug Administration (FDA) Tagged With: blog, Emergo Group

FDA proposes exempting 337 Class II devices from 510(k) requirements

March 16, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: blog, Emergo Group

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