Is toxicology data available on component materials or constituents?
What existing biological data on component materials exist? Is it current
What history of clinical use exists.
Any report is only as good as the data used to support it. Studies should be conducted under GLP or in accordance to ISO 17025 or an equivalent.
In the Gap Analysis the questions that would trigger a new Risk Assessment need to be asked. Has the vendor, source, formulation etc changed since the original evaluation?
The actual data has to be reviewed to current standards and expectations. To summarize the changes between one revision of a guidance document and another does nothing to evaluating whether or not a 20 year old project meets the current standard or if it even met the prevailing standard at the time.
There are a lot of legacy products on the market that had shoddy biocompatibility profiles completed and some with nothing at all.