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.
The ATHENA Award is presented by the Rochester Chamber of Commerce and honors professional women leaders who strive toward the highest levels of personal and professional accomplishments, devote time to their community, and forge paths of leadership for other women.
The reception was hosted at Constellation Brands in Victor, New York, and the winner will be announced on January 25, 2018 at a dinner at the Joseph A. Floreano Rochester Riverside Convention Center.
Good luck, Mary! We're all pulling for you!
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.