Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

Dan O’Mara is a Principal Quality Engineer at iuvo BioScience. He holds a Master’s degree in Regulatory Affairs from Johns Hopkins University and a Bachelor’s degree in Environmental Science with a minor in Chemistry from the University of Rochester.


Dan has over 9 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions including that of a Research Scientist in Nonclinical Safety and a Manager of Regulatory Affairs.

FDA Updates Guidance on Exempt Class II Devices

On July 11, 2017, the US FDA published a final list of Class II devices exempt from 510(k) Premarket Notification Requirements (82 FR 31976).  As mentioned previously here, in an effort to comply with the 21st Century Cures Act of 2016, the Agency originally issued a notice on March 14, 2017 in the Federal Register proposing to exempt a list of Class II devices from the 510(k) premarket notification requirements, with certain limitation (82 FR 13609).  

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FDA Opens Comments on Proposed Laboratory Accreditation Program

The FDA took the first step on the long road of launching a proposed new laboratory accreditation program this month - the Accreditation Scheme for Conformity Assessment (ASCA).

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EU Parliament Votes to Enact MDR and IVDR

In early April the EU Parliament voted to enact the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The regulations are due to be published in the Official Journal of the European Union in May 2017. Following publication, there will be a three year transition period for the MDR and a five year transition period for the IVDR. These regulations will therefore not be fully enacted until approximately June 2020 and June 2022, respectively.

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FDA Releases 71 Device Product Codes Exempt from All Premarket Notification Requirements

 

On April 13, 2017, as part of the US FDA’s continued efforts to comply with the 21st Century Cures Act of 2016, the Agency published a list of 71 low-risk Class I medical device product codes that are exempt from all premarket notification requirements (i.e. 510(k) clearance). While the list includes product codes for ophthalmic and neurological devices, the majority of the devices are for clinical chemistry and clinical toxicology analyte controls.  

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FDA Publishes List of Over 1,000 Devices Exempted from Premarket Notification Requirements

On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)).  

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US and EU Reach Agreement on Pharmaceutical Inspections

On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement.  

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VIVAN LifeSciences
Thanks for sharing this type of information this is really useful. I really like it. Keep updating new blogs.
Thursday, 01 June 2017 12:14
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China FDA Launches New Guidelines

Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines.  These new guidelines include: 

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FDA Updates Comment Period for new GLP Regulations

On October 31, 2016 the US FDA published a notification in the Federal Register (81 FR 75351) extending the comment period for the Agency’s proposal to amend the good laboratory practice (GLP) regulations for nonclinical studies. This extension was due to requests from interested parties asking that the original 90-day comment period be extended by an additional 90-days to allow sufficient time for the partied to develop meaningful and thoughtful responses to the proposed rule.

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Guest — Josey I.
And just to remind that according to FDA these proposals that are meant to amend the regulations for GLP for nonclinical laborator... Read More
Friday, 14 July 2017 06:33
Ahmed Khan
Nice post...
Thursday, 26 October 2017 09:21
Guest — Allan
Thank you for the information! Sure, these new regulations are reflected in a GLP training that provide an overview of the require... Read More
Friday, 17 November 2017 08:01
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