Satisfaction low among MedTech execs with FDA's device approval process

Less than one-third (30 percent) of medical technology executives are satisfied with the FDA’s management of the review process, according to a survey about the 510(k) pathway for new medical devices conducted by the Medtech Resource Alliance.

Almost three-quarters (72 percent) of the 199 med-tech executives respondents had submitted a medical device to the FDA using the 510(k) pathway. Dissatisfaction with the process was high with 34 percent saying they were extremely dissatisfied with the process and 30 percent were somewhat dissatisfied.

The highest dissatisfaction rate (90 percent) was for ophthalmic, neurological and ENT devices, followed by 78 percent for surgical, orthopedic and restorative devices.

The survey asked respondents whose medical device received a not substantially equivalent (NSE) decision from the FDA, about their experience. Just 7 percent said they felt the FDA’s review staff understood the scientific issues surrounding their device in the NSE decision. The majority (61 percent) said they thought the FDA’s review staff did not understand the legal and regulatory issues surrounding their device in the NSE decision.

When asked about the explanation received about the FDA’s analysis of their 510(k) submission when it conducted the stage-gated review or provided an NSE letter, 15 percent said they received a fairly thorough explanation, 33 percent received a short statement with some explanation, 30 percent received an inadequate statement with little to no explanation or justification and 14 percent received a boilerplate statement or reason with no explanation or justification.

The FDA’s requests for additional information are often vague, respondents said. When stating that performance data may not be adequate, 39 percent provided little or no detail. When stating that clinical data may not be adequate, 73 percent included little or no detail. In an overall assessment of communication summarizing the review staff conclusion, only 15 percent obtained full transparency in the document. Asked whether clinical/performance data in the submission had been considered in an NSE decision 28 percent of respondents said no and 38 percent of respondents were not sure.