Biological risk assessment is necessary before any drug or medical device gets final approval for market release. In this risk assessment process, the drug or medical device goes through different levels of tests. These clinical tests check whether the drug or medical device is doing its intended purpose and whether it is safe for humans or not.
You would be happy to know that biocompatibility testing FDA 510K is one of these tests that check the safety of any drug or medical device. Passing these tests is necessary before any company applies for FDA approval. Let’s find out some important aspects of biocompatibility tests.
- Make sure that biocompatibility tests are done at an accredited lab
- Ensure that biocompatibility tests follow a streamlined process
- Make sure that biocompatibility tests are done at an affordable price
Ø Accredited lab
When doing any biocompatibility testing, make sure it is done at an accredited lab. The laboratory must be accredited by ISO, GLP, and AAALAC. Otherwise, different agencies might not accept the test result.
Accredited labs follow the right procedures for doing biocompatibility tests. For this reason, biocompatibility test results from an accredited lab are acceptable everywhere. It will be a waste of money & time if the biocompatibility test is not conducted at an accredited lab.
Ø Streamline process
Many accredited biocompatibility test facilities follow complex processes. Due to this reason, it takes a long time to get the biocompatibility test result. It can be a big hassle for drug or medical device development. For this reason, always try to pick a biocompatibility lab that follows a streamlined process for biocompatibility tests.
At these biocompatibility labs, you will get the biocompatibility test result quickly. As a result, you can develop any drug or medical device faster. Quick biocompatibility test results also help you launch the drug or medical device to the market faster.
Ø Affordable price
Most biocompatibility labs charge a lot of money for different tests. Some biocompatibility tests cost a lot of money such as Hemocompatibility, Subchronic Toxicity, Implantationm, etc. As a result, the drug or medical device development expenses increase a lot.
By choosing an affordable biocompatibility solutions provider, you can conduct these biocompatibility tests at a lot less expensive. As a result, the drug or medical device development expense will go down subsequently. Therefore, you can increase your profit margin when you choose an affordable biocompatibility solution provider.
These days, biocompatibility tests are mandatory for FDA or similar level agency approval. Not passing biocompatibility tests means that your drug or medical device is not ready for the market. A drug or medical device only gets ready for FDA approval when it passes biocompatibility tests.
Most drug or medical device manufacturers are familiar with biocompatibility tests. They know very well that their drug or medical device cannot come to the market without passing biocompatibility tests. If you want these tests done quickly, then look for an accredited biocompatibility solution provider. You would be happy to know that an accredited biocompatibility solution provider follows a streamlined process for these tests.
