Jun 21, 2016
Final guidance issued by the US Food and Drug Administration clarifies and expands on how manufacturers of medical devices that come into contact with the human body should comply with the ISO 10993-1 standard for biological evaluation of devices within risk management frameworks.
FDA guidance on ISO 10993-1 compliance has not been updated since 1995; the final guidance includes several new recommendations for manufacturers in terms of risk-based biocompatibility approaches, chemical assessment and biocompatibility test article preparations for devices utilizing nanotechnology.
Risk-based approaches to biocompatibility
The agency’s recommendations for risk-based biocompatibility evaluation are based on elements of ISO 10993-1:2009. Specific steps that such an approach involves for manufacturers include:
FDA versus ISO 10993-1 compliance
As is the case with many other US medical device regulations, FDA biocompatibility testing guidance may be based on and highly similar to the ISO 10993-1 standard, but not identical.
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“In general, FDA agrees with the framework established in ISO 10993-1 for identification of the nature and duration of contact… However, FDA has made several modifications to the evaluations identified in that standard,” states the FDA, pointing readers to Section IV.D and Attachment A of its new guidance for additional details of these modifications.
“-Free” labeling concerns
One issue raised in the new guidance that manufacturers should note pertains to device labels claiming that a product is “latex-free,” “BPA-free” or some other kind of substance “-free.” The FDA casts doubt on existing testing methods’ ability to prove that a device is completely free of any particular allergen or toxic substance, and instead recommends that firms use the phrase “Not made with [substance.”
However, manufacturers should only use such verbiage on their labeling if it can apply to the entire device as well as all of its packaging—otherwise, manufacturers should specify which components of their products are not made with a particular substance.
The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and regulations pertain to their products.
The US Food and Drug Administration has published a new draft guidance covering design and reporting processes for animal studies conducted for medical devices.