Deciding whether third party review is a favorable cost/benefit proposition for a given 510(k) development programme is not always clear.
Such decision making should be integrated into an overall device development strategy at the earliest stages of development and should be considered in light of the potential for a 513(g) or pre-sub. In recent years, it was estimated that 60% of all 510(k) submissions might qualify for the Accredited Persons Programme.
If you are not clear as to the need or eligibility for a third party review of your 510(k) submission, you would probably benefit by chatting with a medical device consultant. A consultant’s systematic examination of the potential pathways by which your 510(k) may be reviewed will add clarity to your decision making and contribute to optimal results.