Here & #039;s What MD+DI Readers Said About The Bleeding Edge

As part of MD+DI's coverage last week of the Netflix documentary, The Bleeding Edge, we asked readers for feedback on the film and its assessment of the medical device industry. A total of 62 respondents took the three-question survey.  1. The Bleeding Edge claims that FDA's 510(k) process, reportedly the most popular way medical devices reach the U.S. market, doesn’t require the submission of as much safety data as does the premarket approval (PMA) process. Do you believe this is a fair depiction? Of the 62 respondents who answered this question, 48 (77.42%) said yes, and just 14 (22.58%) said no. Additionally, 25 respondents chose to explain their answer. Those comments include the following, selected to represent the full range of viewpoints: "FDA requires evidence that any device will be clinically safe (and also effective). In the case of a 510(k), a predicate is submitted by the applicant and judged by FDA as a comparison to the device seeking marketing approval. The collective data supplied for both the predicate and the new device are judged by FDA for sufficient evidence that the new sought device will be safe. The preponderance of evidence necessary for a PMA device or a 510(k) device may be considered the same, it's just a matter of whether there's a predicate to start from. 1976 was the baseline for which predicates began. However, that was 42 years ago." "Since its introduction in 1976, the 510(k) path for medical device ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news