1. The effectiveness of the present FDA-mandated postapproval study program is unclear, due in large part to variability in characteristics of individual postapproval studies.
2. The postapproval study program has resulted mainly in FDA requests for device label changes; the impact of these changes on physician and patient decisions is unclear.
Evidence Rating Level: 2 (Good)
Study Rundown: High-risk medical devices often undergo fewer premarket clinical trials than pharmaceuticals; thus it is important to study postmarket safety and efficacy to ensure patient protection. The US Food and Drug Administration (FDA) has implemented a strategic plan for postmarket surveillance of medical devices that includes FDA-mandated postapproval studies (PAS). The goal of PAS is to “gather specific information to address questions about the postmarket performance of or experience with an approved medical device,” which has the potential to result in medical device withdrawal from the market. This study sought to examine the characteristics and information accessibility of PAS, and to assess the overall effectiveness of the FDA’s PAS program.
This descriptive study found that there were variable details on reasons for the ordered PAS, the studies’ hypotheses or end points, and the causes for PAS implementation delay. The FDA mandate states that if the manufacturer does not comply satisfactorily with PAS requirements, warning letters, monetary penalties or device approval withdrawal could be initiated. However, the FDA has never issued any such penalties. This study was the first to analyze the quality of the FDA’s PAS program. However due to the inconsistency in information available from the FDA, the study was unable to draw conclusions on the effect of the studies. Further collaboration with stakeholders will help to ensure that PAS are effectively improving public health.
Click to read the study, published today in JAMA Internal Medicine
Click to read an invited commentary in JAMA Internal Medicine
Click to read an editorial published in JAMA Internal Medicine
Relevant Reading: Left to their own devices: Breakdowns in United States medical premarket review
In-Depth [descriptive study]: This study used the publicly available FDA PAS website to abstract information on all 223 PAS done between 2005 and 2011. The website contained information on device names, study characteristics and statuses of manufacturer reports to the FDA on PAS programs. It also contained information on which approval track each device used to enter the market. Approximately 48% of all premarket approval applications had PAS. The author-assigned PAS study designs included prospective cohorts (49%), follow-up (27%), randomized controlled trials (3%) and others. PAS could also be mixed methods (e.g., prospective cohort and follow-up). Study progress was depicted on the FDA website with general status labels (completed, progress adequate, progress inadequate, study pending, other, terminated), however no further detail on specific reasons for inadequately progressing PAS was available.
There were 58 completed studies, 93% of which included in-depth information on patient enrollment, follow-up rates and safety and effectiveness findings. There was a median delay of 6 months for 37% of all PAS. The PAS were used by the FDA to address specific concerns about safety and efficacy and thus had small sample sizes with an average of 350. Of the completed PAS, 53% resulted in requests for device labeling changes, which was the most common result of a PAS. However, it is unclear if these label changes influence physician and patient decisions. One device was removed from the market due to adverse events that were identified in the PAS.
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