SALT LAKE CITY, Sep. 16, 2013 – 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.
New FDA Draft Guidance
FDA placed into a draft guidance document its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on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.
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.
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.”
About Nelson Laboratories: 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.