Navigation Links
2013 to Be a Big Year for Biocompatibility; Nelson Labs Participates in Potential Updates
Date:9/16/2013

SALT LAKE CITY, Sept. 16, 2013 /PRNewswire/ -- 2013 is shaping up to be a big year for biocompatibility and Nelson Laboratories (www.nelsonlabs.com) is in the thick of it with its involvement in the ISO 10993 Working Group, participation in round-robin testing of a potential in vitro replacement for Rabbit Irritation Testing and leading in the discussion regarding biocompatibility guidance on the horizon from FDA.

(Logo: http://photos.prnewswire.com/prnh/20120727/LA47745LOGO)

New FDA Draft Guidance

FDA placed into a draft guidance document its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility.

"The draft document has been out since April and widely available," said Thor Rollins, Biocompatibility Expert at Nelson Laboratories. "It has not been formally released, but there is a lot of buzz about the document. Many people are having a difficult time interpreting what is different, what has changed and what kind of impact it will have moving forward. Though only a draft, it does give insight on what FDA is thinking."

The document is in three categories:

  • Summary of Ideas – a summary of ideas FDA has expressed for a few years.
  • Justification Ideas – FDA spells out general ideas of how to justify biocompatibility choices. FDA has never done that before.
  • Possible Impacts – shows possible impacts never before seen regarding biocompatibility.(Read More)

ISO 10993 Working Group

Nelson Laboratories recently participated in the ISO 10993 Working Group's Italy Sessions where three new updates were released.

Sensitization and Irritation – The European Center for the Validation of Alternative Methods (ECVAM) performed a validation for an in vitro irritation test for cosmetics to replace the rabbit irritation test. Nelson Laboratories is participating in the study to see if the validation will apply to medical devices in a three-phase process. A similar process will take place after ECVAM completes a similar validation for sensitization.

Systemic Toxicity – A new test will look at chemicals that are systemic, which is more concerning to toxicologists than localized toxicity. The goal is to find ways to become more efficient when looking at polar and non-polar extracts with toxicity studies.

Threshold of Toxicological Concern (TTC) – The working group is working to write a document that uses the concepts of TTC with medical devices in which you look at the chemicals coming off of a device and analyze them using safety information. This will be a key focus of the ISO 10993 working group leading up to the next meeting in Japan.
(Read More)

Replacement of Rabbit Irritation Test

Nelson Laboratories is currently participating in round-robin test validations involving several different labs to demonstrate that medical device extracts can illicit the same predictive response with the irritation tests as those conducted by ECVAM. If the tests are successful, the in vitro tests can potentially become more efficient, user fewer or no animals, and save costs and time. FDA currently does not accept the test for medical devices saying there is no proof that extractions can elicit a response. FDA approval will depend on the round robin testing.

As an active participant in each of these biocompatibility initiatives, Nelson Laboratories is uniquely qualified to guide medical device manufacturers on how these potential changes will affect their business and manufacturing processes. The Company's scientists are available to answer questions regarding all aspects of biocompatibility. Read the Nelson Labs blog for more in-depth information on these topics. (Read More)

For additional in-depth information regarding these topics, Nelson Laboratories recently conducted a webinar entitled, "How the New FDA Guidance on ISO 10993 Could Possibly Affect You."

Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and collaborate with you to achieve your long-term business goals. It's what we call The Science of Success™. It's transparency in the testing process. It's approachable experts that guide you through ever-changing compliance requirements. It's helping you mitigate risk, be first to market, and succeed with your customers. Learn more at www.nelsonlabs.com.

Contact:
Cory Maloy
Snapp Conner PR
801-994-9625
acory@mac.com


'/>"/>
SOURCE Nelson Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Stuart Nelson, MD, FACMI, Joining Apelon
2. My Cleaning Products Reveals Nelson Castro Once Sponsored a Bed Bug Bill, Offers Samples of Non-Pesticide Bed Bug Spray
3. Nelson Laboratories to Teach Free Sterilization Validation Classes at 2013 MD&M East Show
4. Dual-acting class of antimalarial compounds discovered with potential to prevent and treat malaria
5. The Pharmabiotic Research Institute (PRI) is Preparing to Publish its First Works on the Therapeutic and Medicinal Potential of Probiotics
6. Carnegie Mellon study reveals potential of manganese in neutralizing deadly Shiga toxin
7. GeoVax Labs Presents New Findings on Potential HIV Vaccine at 2012 Conference on Retroviruses and Opportunistic Infections (CROI)
8. Carbon capture and storage -- new research from UKERC shows tough road ahead to realize potential
9. Researchers Find Potential Link Between Drinking Alcohol And Breast Cancer
10. Golden potential for gold thin films
11. Exosome Diagnostics Presents Data at American Urology Association Demonstrating Potential Utility of Urine Exosomes to Non-invasively Detect and Manage Prostate Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2017)... (PRWEB) , ... June 19, 2017 , ... A colony ... among its cells and tissues by delivering pollen and nectar containing nutrients necessary for ... means to stay healthy. , Many recent indicators point to a decline in honey ...
(Date:6/16/2017)... ... June 16, 2017 , ... Cambridge ... announced that its Anzo Smart Data Lake® (Anzo SDL) solution was named ... the 2017 Software & Information Industry Association (SIIA) CODiE Awards. , Finalists ...
(Date:6/15/2017)... ... June 15, 2017 , ... New resistant soybean ... options for managing Palmer amaranth and other broadleaf weeds resistant to glyphosate. But ... necessary. Auxin herbicides are known to drift and to cause harm to sensitive, ...
(Date:6/15/2017)... ... June 15, 2017 , ... ... (EKG) follows an artist’s journey through creative experimentation and interdisciplinary collaboration. Feature Creep, ... through July 22nd. An opening reception will be held at EKG, located at ...
Breaking Biology Technology:
(Date:3/24/2017)... 2017 Research and Markets has announced the ... & Trends - Industry Forecast to 2025" report to their ... The Global ... CAGR of around 15.1% over the next decade to reach approximately ... the market estimates and forecasts for all the given segments on ...
(Date:3/23/2017)... Research and Markets has announced the addition ... - Industry Forecast to 2025" report to their offering. ... The Global Vehicle ... around 8.8% over the next decade to reach approximately $14.21 billion ... estimates and forecasts for all the given segments on global as ...
(Date:3/22/2017)... 21, 2017 Optimove , provider ... retailers such as 1-800-Flowers and AdoreMe, today announced ... and Replenishment. Using Optimove,s machine learning algorithms, these ... and replenishment recommendations to their customers based not ... of customer intent drawn from a complex web ...
Breaking Biology News(10 mins):