Endotoxin testing - Raw materials and components of a Class III medical device

J

jampot

#1
Would anyone be able to advise of the regulatory requirements for endotoxin testing raw materials/components of a medical device.

We are developing a Class III device and in addition to endotoxin testing the final manufactured device also are also considering testing the two main components for endotoxin content.

Is the testing of the latter actually necessary?

Many thanks in advance:)
Jampot
 
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C

CertifiedDataJunkie

#2
Just to start the discussion ...

Definition of a Class III Medical Device ...

Class III - Premarket Approval

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.

Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Not all Class III devices require an approved premarket approval application to be marketed. Class III devices which are equivalent to devices legally marketed before May 28, 1976 may be marketed through the premarket notification [510(k)] process until FDA has published a requirement for manufacturers of that generic type of device to submit premarket approval data.

Class III devices which require an approved premarket approval application to be marketed are those:

regulated as new drugs prior to May 28, 1976, also called transitional devices.
devices found not substantially equivalent to devices marketed prior to May 28, 1976.
Class III preamendment devices which, by regulation in 21 CFR, require a premarket approval application.
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.

Class III devices which can be marketed with a premarket notification 510(k) are those:

postamendment (i.e., introduced to the U.S. market after May 28, 1976) Class III devices which are substantially equivalent to preamendment (i.e., introduced to the U.S. market before May 28, 1976) Class III devices and for which the regulation calling for the premarket approval application has not been published in 21 CFR.
Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and endosseous implants.
When is endotoxin testing required?

The FDA Center for Devices and Radiological Health requires devices in contact with circulating blood or cerebrospinal fluid to be nonpyrogenic. Intraocular lenses also are required to be nonpyrogenic. Requirements for other products are decided on a case-by-case basis by the FDA. Manufacturers planning to use the Limulus Amebocyte Lysate (LAL) test as a pyrogenicity test for devices must validate and test according to the FDA draft LAL guideline or submit data from an alternate method to FDA for review. Traditionally, nonpyrogenic water or saline is used to rinse devices for LAL testing. Data from our initial studies on endotoxin recovery from devices using sodium lauryl sulfate demonstrate higher recovery than with nonpyrogenic water. This method, which provides an alternate rinse solution for recovery of endotoxin from medical devices is undergoing collaborative study.
Endotoxins and Medical Devices

Given the stringent nature of Category III devices and the likelihood that they meet the requirements for endotoxin testing, it is a conservative recommendation to consider the raw materials and components of the device as a source of endotoxins.:caution:

I would have liked to find a more current citation for these requirements, but it is a starting point.:2cents:
 
J

jampot

#3
Many thanks for this.

So if I interpret correctly, there is no regulatory requirement to test components of a medical device for their endotoxin content. The key point is that the final product is tested using a validated method.

Jampot
 
P

Paragon

#4
Dear Jampot,

I am interested to know about your products as we are dealing in Endotoxin products...

Where you are getting Blood of Horse Shoe Crab?
 
P

Paragon

#6
Hi Jampot !

There are only 3 producers of Endotoxin products;

Cape Code
BioWhittaker™ is Cambrex
Charles River

I have very good experience working in Pharmaceutical, sterile area designing and construction.
 

lindal

Involved In Discussions
#7
Hi Jampot !

There are only 3 producers of Endotoxin products;

Cape Code
BioWhittaker™ is Cambrex
Charles River

I have very good experience working in Pharmaceutical, sterile area designing and construction.
Cape Cod recently withdrew some of their Pyrotell Multitest LAL (http://www.fda.gov/cber/recalls/lalacc030907.htm) and is not selling/ will not sell us the LAL that we purchase, which has a different product code.
How much revalidation/ qualification will be required to switch to an equivalient product by Lonza (Cambrex) or Charles Rivers?

Incidentally, we never received a change notification and there isn't anything on their website about this.

Has anyone had to deal with a similar situation? If so, what did you do?

L
 
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