Registration for a live webinar on 'Neuroleptic malignant syndrome' is now open.
See webinar detailsWe noted you are experiencing viewing problems
-
Check with your IT department that JWPlatform, JWPlayer and Amazon AWS & CloudFront are not being blocked by your network. The relevant domains are *.jwplatform.com, *.jwpsrv.com, *.jwpcdn.com, jwpltx.com, jwpsrv.a.ssl.fastly.net, *.amazonaws.com and *.cloudfront.net. The relevant ports are 80 and 443.
-
Check the following talk links to see which ones work correctly:
Auto Mode
HTTP Progressive Download Send us your results from the above test links at access@hstalks.com and we will contact you with further advice on troubleshooting your viewing problems. -
No luck yet? More tips for troubleshooting viewing issues
-
Contact HST Support access@hstalks.com
-
Please review our troubleshooting guide for tips and advice on resolving your viewing problems.
-
For additional help, please don't hesitate to contact HST support access@hstalks.com
We hope you have enjoyed this limited-length demo
This is a limited length demo talk; you may
login or
review methods of
obtaining more access.
Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Medical device versus medical device combination product (MDCP)
- Medical device and MDCP regulation in the US versus the EU
- How drugs biologics are regulated versus MDCPs
- Overview of current combination product regulatory landscape
- Biocompatibility: integrated assessment of biological safety (1)
- Biocompatibility: integrated assessment of biological safety (2)
- Biological safety endpoints: how to identifiy endpoints of consideration
- Biological safety endpoints: ISO 10993 biological safety tests
- ISO 10993 biological safety tests (1)
- ISO 10993 biological safety tests (2)
- ISO 10993 biological safety tests (3)
- ISO 10993 standards: methodologies for testing
- Related Henry Stewart Talks
- Acknowledgements
Topics Covered
- Medical device
- Medical device combination product
- Biocompatibility
- ISO standards
- Biological safety tests
Links
Series:
Categories:
External Links
Talk Citation
Lanning, C.L. (2020, September 30). Biological safety testing: supporting medical device combination products [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 4, 2024, from https://doi.org/10.69645/PNDD6550.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, I am Christine Lynn Lanning from Merck & Company, Incorporated.
I'm going to review the biological safety testing that is needed
to support development of medical device combination products.
0:13
Although much of this information is also applicable for a medical device,
I'm focusing the talk on MDCPs,
a medical device combination product,
which is the medical device in combination with a drug or biologic.
As such, this talk,
will introduce you at a high level to the requirements and testing that must be
satisfied to support the device aspect of the medical device combination product.
Specific testing requirements for the drug biologic component of the MDCP also
need to be satisfied and are covered in
other HS Talks, referenced at the end of this presentation.
0:48
One may ask, what is a medical device versus a medical device combination product,
often referred to as an MDCP.
A medical device is an apparatus or agent used to prevent or treat a disease or injury.
It may support life,
it may replace or support anatomy or a physiological process.
Some common examples that come to mind are thermometers, ultrasound, surgical equipment,
mesh, catheters, artificial joints,
and even hardware such as rods and screws that may be implanted.
It is important to note a medical device does not achieve
its primary action by pharmacological or metabolic means.
Now, a medical device combination product is the medical device
in combination with the active pharmaceutical ingredient or API,
that can be a drug or a biologic agent.
In this case, the device often is used to deliver the API to the intended site of action.
Some examples include an inhaler,
a prefilled syringe, or even a drug delivering implant.
Hide