Primary Care Corner with Geoffrey Modest MD: Regulation of Medical Devices

By Dr. Geoffrey Modest

If you thought that the FDA was approving too many drugs without adequate testing, just look at the approval process for medical devices!!! (see JAMA. 2015;314(6):604-612). The process is a tad complex. Studies are designated as “pivotal” if they were used by the FDA for premarket evaluation of safety and effectiveness as the primary basis for approval; others done premarketing were considered “non-pivotal”. Premarket approval is the primary way that novel devices are approved — those devices which support/sustain life, prevent illness, or prevent unreasonable risk to the patient. The overall process also allows for post-market approval studies, including for changes made to the devices through supplemental applications. The current study assessed this overall process, given the increasing concerns that high-risk devices make it into the market without adequate testing: the FDA has indeed been accepting more “flexible” premarket evidence for new devices in order to expedite patient access. The FDA reserved the potential to require postmarketing data collection to help assure that the devices are safe and effective, looking at the “total product life cycle” to try to fill this gap.


  • They looked at 28 high-risk therapeutic devices approved by the FDA through the premarket approval pathway between 2010-2011. Then in October 2014, they looked at all the studies in (studies on devices, per FDA regulations in 2007, are required to be logged into, as well as any others they could find (including the manufacturer websites), assessing the study status of pre-approval studies, FDA-required post-approval ones, and manufacturer/investigator-initiated studies.


  • 286 clinical studies were identified for high-risk therapeutic medical devices:
    • 82 premarket (28.7%):  30 were pivotal and 52 were nonpivotal.
    • 204 postmarket: 33 were required post-approval studies by the FDA (11.5% of the studies done), 171 were manufacturer/investigator-initiated studies (59.8%).
  • Study completion rates:
    • Premarket: 44 (84.6%) nonpivotal and 30 (100%) of pivotal were reported as completed. For these approved devices, the median total number of completed studies for pivotal and nonpivotal studies was 1, the number of patients was 241 for pivotal and 65 for nonpivotal, and the median duration of the longest follow-up for pivotal studies was 3.0 months. (1.5 months for nonimplantable devices and 12.0 months for implantable). Of note, 63.3% of the studies were open-label, only 20% were double-blind, and 20.5% relied on surrogate markers of disease.
    • Postmarket: 6 (18.2%) of the 33 FDA-required studies and 20 (11.7%) of manufacturer/investigator-initiated studies were completed, with 23 (69.7%) and 130 (76.0%) respectively listed as “on-going” 3+ years later.  Of the completed postmarketing studies, the median longest follow-up was 9 months.
    • In terms of funding, all the pivotal studies premarketing were done by industry, as were 50% of the postmarketing studies.

So, bottom line:

  • Medical devices are pretty marginally regulated and based on pretty unimpressive studies: for the FDA-required pivotal studies (which directly measure efficacy and safety), on average only one study was done (and 80% of the studies were not double-blind), with only 241 people, and a paltry 3 months of follow-up, and often used only surrogate markers.  Of those that the FDA required post-market evaluation (often required given the laxity of the premarket evaluation process), the studies were similarly small, unblinded, limited to 1 year, largely focused on surrogate endpoints and without active comparators, and fewer than 1 in 5 actually had data completed within 3 years (though the FDA has not imposed any penalties on the manufacturers). And, per FDA rules, any modification of devices requires very minimalist data for approval (e.g., allowing just surrogate markers). Of concern, several other studies find that clinicians overall do rapidly adopt the new technologies soon after they are introduced into the market.
  • The blog published 8/27/15 on implantable defibrillators brings out another aspect of the inadequacy of regulation: ICD approval was based on studies in younger people who had stable angina in an outpatient setting, but usage of ICDs has dramatically morphed to include older patients in an acute inpatient setting. And this large observational study in fact found that there is NO benefit for this group, despite noting that one-third of ICDs are currently implanted in Medicare recipients in the acute setting, with the attendant very large costs and attributable adverse events.
  • And, I suspect that much of the continuing disempowerment of the FDA and federal regulation in general is related to the increasing trend of popular governmental distrust and simultaneous embracing of privatization. Of current concern,  there is a 2016 spending bill before the US Congress to defund the Agency for Healthcare Research and Quality, AHRQ  (see ), where Richard Kronick, the head of AHRQ notes “the mission of the Agency for Healthcare Research and Quality is to produce evidence to make health care safer, higher quality, more affordable, accessible, and equitable.”  This mission is different from and compliments that of the NIH to promote basic biomedical research. AHRQ looks at the gap between current medical practice and recommended evidence-based care: how medical discoveries are incorporated into medical care delivery. This attempt at defunding AHRQ, needless to say/write, is very disturbing to those of us currently practicing medicine and the patients we serve, given the increasing evidence of exaggerated and sometimes falsified drug/device company promotions: unfortunate complications of medical devices (e.g., mesh used in bladder prolapse surgeries subsequently moving and penetrating nearby organs) as well as several medication issues (e.g., Merck withholding publication of negative studies of gabapentin..), also see several recent blogs: , a blog on the diabetic med sitagliptin, highlighting the lack of clear clinical benefit , one of several I have sent out on dabagratan (some prior to the BMJ on-line blogs), though this one summarizes several issues, including the fact that the drug company hid their own internal evidence showing that drug levels should be monitored (they hid this because their promotion was largely that dabagratan was superior to warfarin since there was no need to monitor INRs/drug levels…) presents a study showing a large number of drug company studies listed on​ did not have final results on the website, and they were are not published in medical journals.​

(Visited 1 times, 1 visits today)