AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications

The device industry is awaiting the final FDA rule on medical device classification procedures, and will be combining it with the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12 Federal Register.

Trade association AdvaMed is leading the charge against the proposed rule, which was written in response to changes to the federal Food Drug and Administrative Safety and Innovation Act, which allows the FDA to reclassify a device by administrative order rather than regulation, explains the FDA Law Blog.

The Association of Clinical Research Professionals wrote a brief comment in support of the changes in the proposed ruling, which are described below. There are only four comments in the docket so far, but more are likely on the way due to the extension.

The proposed rule changes the definition of a Class III device. Most notably, the proposed rule adds 5 examples under which the agency can determine that "there is insufficient information to determine if general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness," meaning a device could be classified (or reclassified) into Class III and require a PMA for approval, according to the FDA Law Blog.

These include devices that pose significant risks, have an unfavorable or unknown risk-benefit profile, need a full review of manufacturing information, require changes that could effect its safety or effectiveness and drug/device combination products.

"These changes alone are not insignificant and would substantially expand the scope of devices requiring approval of a premarket application (or 'PMA')," AdvaMed wrote in April, adding that they are "not limited to FDA interpretation and implementation of provisions related to FDASIA."

The trade association is worried the regulation will result in more PMA applications stating: "We estimate substantial increase in the number of required PMAs as regulatory challenges will only increase for manufacturers navigating the classification process. We have seen evidence of this in recent efforts initiated by FDA to revise the classification of long-standing, well-established products to class III from class II and even class I products as well as increase requests for line item, manufacturing, and other data in premarket notification submissions akin to PMA requirements."

AdvaMed estimates that a PMA applications takes 4,380 hours to file on average, compared to the FDA's estimate in the proposed rule of 497 hours. The comment says that the average cost of supporting a PMA is $5 million, and some device clinical trials have cost more than $50 million.

The comment requests the FDA to provide information on the regulations, guidance documents and product codes that will change as a result of the new definition of a Class III device. Of course, industry would be happier if the definition change was scrapped altogether.

- read the AdvaMed comment
- and the comment from the Association of Clinical Research Professionals
- here's all the comments in the docket
- here's the FDA Law Blog's take on the proposed rule