FDA’s 510(k) Recommendations

In the latest step in its process to reform the 510(k) device approval process, following public comment and hearings on the report issued last August, the FDA released a list of 25 recommendations it hopes to implement in 2011.  Industry reaction was generally favorable, probably due as much as anything to fears that changes might greatly increase the time and cost of getting these approvals and increase uncertainty, but the initial recommendations appear fairly mild.   (FDA Release) The 510(k) process generally allows a new device to be approved quickly if it is similar to one already approved.

The release of recommendations includes providing more guidance on when clinical data is needed, on when multiple predicate devices can be used and on interactions with the FDA staff.  The guidances are important as they give manufacturers the opportunity to have greater certainty on how their submissions will be viewed and what needs to be in the submissions.  The recommendations also include a variety of internal improvements related to FDA staffing, training, knowledge management and overall processes.  Another portion of the recommendations is aimed at better tracking of devices once they are on the market and a better database of adverse events.

One industry subsegment particularly concerned about the 510(k) process is the wireless/telemedicine industry.  Many new innovative uses have been identified for these technologies to help in many areas of health maintenance and health care.  Right now that subsegment is beset with regulatory uncertainty and needs some specific guidance from FDA.  A healthy medical device industry is probably overall a good thing for the US, although there are concerns about its effect on spending.  The regulatory environment, in any event, needs to be transparent and fast.