January 19, 2020 - The updated version of ISO 10993-18, the standard covering the chemical characterization of the ISO 10993 biocompatibility standard for medical devices, has just published. The new version is available here.
December 18, 2019 - In the spirit of giving back to those a little less financially fortunate, the iuvo BioScience Community Outreach Team adopted two families in need to help make their holidays a little bit better. This is the third year in a row that iuvo has participated in the program.
November 21, 2019 – iuvo BioScience Chief Scientific Officer Dr. Mary Richardson will be speaking on career paths at the University of Rochester on Monday, December 2nd, at 4:30pm ET.
September 3, 2019 – iuvo CEO Ben Burton was interviewed on the Legal Drugs Podcast in the most recent episode (episode 5) which became available September 2.
You are invited to attend the upcoming Society of Toxicology (SOT)-sponsored webinar hosted by Ocular Toxicity and Medical Device/Combination Product Specialty Sections (OTSS and MDCPSS) of the SOT. The details are provided below. Iuvo’s own Dr. Kathleen Krenzer is the President of the Ocular Toxicology Specialty Section of the Society of Toxicology.
May 10, 2019 - Ten iuvo employees volunteered at an Epilepsy Pralid Individualized Residential Alternative (IRA) home yesterday as part of the Rochester Day of Caring event.
Wednesday, April 17, 2019 - The air was tense as the inaugural iuvo Chili Cook-off to Support the United Way got under way in the iuvo Canteen at high noon-ish on Wednesday. The contestants had been preparing for, well, at least 24 hours, for this challenge.
iuvo will be teaming up with R&Q for a webinar on Biocompatibility: EU MDR and the Changing Regulatory Landscape. The webinar is March 26, 2019, from 1-2pm ET. The slides, webinar recording, and Q&A will be made available to registrants after the webinar.
On Friday, March 8, 2019, Dr. Mary Richardson and Dr. Kathleen Krenzer from iuvo's toxicology department lectured and conducted a workshop on ISO-10993 Biocompatibility testing at the University of Rochester.
March 4, 2019 – Several members of the iuvo BioScience toxicology team co-authored a paper entitled Suitability of Long-Term Frozen Rat Blood Samples for the Interrogation of Pig-a Gene Mutation by Flow Cytometry.
The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.
On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
January 28, 2019 - iuvo Chief Scientific Officer and cofounder Dr. Mary Richardson presented at the Sixth Annual Girl Scouts “Women who ROC” seminar series on Friday, January 25, 2019. The event allows local women leaders the opportunity to talk to the scouts about how to build successful careers.
On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its "intended use" rule due to concerns raised by the industry.
Dr. Mary Richardson, iuvo's Chief Scientific Officer, was honored Wednesday evening, January 17, 2018 at a reception with the other finalists for the 2018 ATHENA Awards.
There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception. We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers. The summaries below link to some of the more interesting guidance documents recently released.
Hello, and Happy Holidays!
Welcome to our first edition of “iuvo InSights”, our newly established monthly newsletter. There are a number of very exciting things happening at iuvo BioScience, and across the industry – and each month this newsletter will provide a sampling of the things we are doing, what we are seeing and how we can use these insights to help you…our Customer.
On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff" is meant to outline the agency's current thinking about devices made via these processes and will be supplemented by a webinar in January. More information on the webinar is available here.
The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing.
October 21, 2017 - Members of the iuvo toxicology team co-authored a paper in the October 2017 issue of Comparative Medicine, the international journal of the American Association for Laboratory Animal Science.
As I begin to isolate single bacterial colonies for mutagenicity testing, I couldn’t help but wonder why the bacterial reverse mutation assay has evaded alternate and new technologies for detecting xenobiotic-induced mutation. Of course there is substantial literature and historical data on the salmonella and e. coli strains in wide use today, and there are internationally recognized testing strategies that have been harmonized throughout the past several decades. However, do the highly mutated and compromised bacterial test systems provide any insight into key events along the pathway to mutation? In this day and age, is this the only option to understand the potential for direct DNA reactivity?
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).
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).
iuvo's CEO Ben Burton was the feature interview on Launch Team Inc's Beer & Blog Feature today, in an interview with Michele Nichols, Launch Team's President. The Beer & Blog format includes an interview combined with a beer tasting.
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.
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.
iuvo’s Director of Analytical Chemistry, Dr. Chris Houston, recently co-authored an article in the PDA Journal of Pharmaceutical Science and Technology entitled “Simulated Leaching (Migration) Study of a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.”
The article is available at http://journal.pda.org/content/71/2/68.full.pdf+html
EDITOR’S NOTE: The author, Dr. Chris Houston, serves on the PQRI-PODP working group as well as a sub-group for Ophthalmics, which is led by iuvo Chief Scientific Officer Dr. Mary Richardson.
I recently attended the 3rd FDA/PQRI Conference on Advancing Product Quality held March 22-24, 2017 in Rockville, MD. I was invited to speak about pending output from the PQRI Working Group on Extractables and Leachables in Parenteral and Ophthalmic Drug Products (PODP) with respect to best practices in ophthalmic drug products.
Last week, iuvo BioScience celebrated our second anniversary. At times, the two years seem to have flown by in an instant – memories of closing the deal, the Day One presentations in Erie, PA, and Rush, NY, the countless client calls and visits are all as fresh in my mind as if they happened yesterday. On the other hand, the amount of hard work the entire organization has put into making this a vibrant, growing endeavor makes me wonder “Has it really only been two years since we began this journey?” A dear friend of mine (and a member of our Board of Directors) calls these “dog years”…referring to the amount of learning and growth that has occurred and feeling like each year is more like seven.
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)).
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.
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.