The FDA has unveiled a new draft guidance aimed at enhancing the consistency and reliability of biocompatibility testing for medical devices

Dive Brief:

• A draft guidance on the evaluation of medical devices' biocompatibility has been released by the Food and Drug Administration
• The FDA responded to issues it said it frequently finds in premarket applications in the document, which it issued on Thursday. The FDA claimed that inconsistent reports are caused by variations in analytical chemistry methods throughout labs.
• The FDA has published suggested methodological techniques for device biocompatibility chemical analysis in an effort to support the uniformity and dependability of analytical chemistry investigations. Feedback on the draft is being accepted by the FDA through November 18.

Dive Insight:

The FDA assesses whether components in medical devices that come into contact with the body could result in unacceptable adverse biological reactions. By describing the compounds that their medical equipment may release into the body, manufacturers may produce the necessary proof. According to the FDA, chemical characterisation can expedite biocompatibility testing and decrease animal testing.

The draft guidance states that although the FDA currently has consensus criteria and biocompatibility guidelines, none of the current publications offer a thorough process for conducting extractables tests and chemical analyses of device extracts. The guidance gap has been recognized by the FDA as a possible contributor to the variations in analytical chemistry practices among labs and the ensuing inadequacies in premarket filings.

The FDA has responded by releasing a 45-page draft guidance paper that offers suggestions on how to gather and submit data on chemical characterisation. The document focuses on extractables investigations, which use laboratory extraction conditions and vehicles to identify and quantify chemicals released from a material or device.

According to the FDA, the most popular kind of chemical characterization study is an extractables study. Businesses conduct the research outlined in the draft to determine chemical equivalency to a medical device that has previously been shown to be biocompatible, screen for nonspecific extractables, or test for specified extractables to evaluate biocompatibility endpoints.

The guidance has been divided by the FDA into sections that address data reporting, chemical analysis, test article extraction, information collecting, and testing. The sections include specific recommendations, such as the one to carry out extractions in triplicate for every solvent. There are four appendices with more information.

Visit our website for more details: https://mavenprofserv.com/