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.
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. All of the guidance documents are commitments made as part of MDUFA IV. A link to the announcement of these guidance documents is here. iuvo […]
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. The article is entitled “Sequelae of Occult Aggression Disqualifying Young, Socially Housed, Female New Zealand White Rabbits (Oryctolagus cuniculus) from Participation in Dermal Toxicology […]
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 […]
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). 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 […]
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). In early April 2017, the US House and Senate committees released a bill to reauthorize the Medical Device User Fee Act (MDUFA IV). As part of the […]
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. The menu included a discussion of how M&A fits into iuvo’s growth strategy, a look back […]
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 […]
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 […]
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 Dr. Houston has been with iuvo BioScience for almost two years. […]
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 […]
