Preclinical Stage

The bench testing required by the FDA for 510(k) and PMA submissions often is determined by available predicates, standards organizations and known device issues. RA is a valuable resource for gathering this information and helping the product development team identify the testing methods that will be required by the FDA and determining the most efficient, effective, and compliant testing strategy.
For example, with a 510(k) submission, the FDA wants the medical device company to do the following:

• Test its device.

– If testing standards exist with acceptance criteria this process is fairly straightforward.
– However, if there are no standards or existing standards do not include acceptance criteria, the burden is on the manufacturer to:
~ Test another legally U.S. marketed device (predicate) using the exact same testing method; and
~Compare the devices head to head in order to prove that the newer device is substantially equivalent (in effect, as safe and effective) as the predicate.
– In some cases, published biomechanical literature may be used for comparative purposes as well.

• The best way for any medical device manufacturer to approach testing is to run any and all design differences through its regulatory affairs team so that RA can help ensure that:

– A predicate exists that the FDA will accept;
– There’s a solid risk management plan in place;
– FDA guidance documents for testing are adhered to; and
– All available standards and literature for testing are evaluated and applied where appropriate.