Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

Abstract

IMPORTANCE Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence. OBJECTIVE To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available. DESIGN Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices. MAIN OUTCOMES AND MEASURES For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided. RESULTS Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness. CONCLUSIONS AND RELEVANCE Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.

Software‐Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

“…For all those high‐risk recalls that satisfied those criteria and also for moderate‐risk recalled EMRs, we used the FDA's databases to determine the type of testing used as the basis of the FDA's regulatory determinations that allowed the devices to go on the market. This included reviewing any relevant data or testing information described in device companies’ 510(k) publicly available summaries, as described in an earlier study …”

“…Premarket approval (PMA), the FDA's most stringent review process for devices, applies to software posing the greatest risk to patient safety and requires the manufacturer to provide clear evidence of safety and effectiveness. In contrast, products expected to pose less risk to patients, and thus go through the 510(k) review process, are not required to be proven safe, effective, or accurate but instead must demonstrate that they are similar to a product already sold in the United States in order to be cleared for market by the FDA …”

What type of clinical evidence is needed to assess medical devices?

“…Large investments in research are being made by several stakeholders, including the European Union (www.medtechta.eu/wps/wcm/connect/Site/MedtecHTA/Home, www.adhophta.eu and www.advance-hta.eu), to deepen our knowledge on current methods for assessing medical devices, especially dealing with clinical evidence. The debate on regulation of medical devices has very often focussed on the type and role of clinical evidence [3,[34][35][36]. Clinical evidence for medical devices is often more challenging to collect through traditional experimental studies such as RCTs and, although RCTs rank high in terms of internal validity, other sources of data can be relevant and reliable to take policy decisions [37], especially when the adoption and diffusion of new devices largely precede any RCTs.…”

Obstacles to Studying Emerging Technologies

“…Despite public disclosure laws, the scientific basis for determining substantial equivalence between predicate and newly approved devices is not always publically available or clearly described. 1 As consumers of power morcellators, we searched the FDA web site (http://www.fda.gov/MedicalDevices) to identify their predicate devices. Through a series of "substantially equivalent" devices, the Internet trail ends at the Cook Tissue Morcellator, approved in 1991.…”

“…3 Many recalls of devices deemed "moderate risk" and approved through the 510(k) process have been associated with major complications; the devices have posed more than a moderate risk to patients. 1 In 2011, an Institute of Medicine report concluded that the 510(k) pathway is fundamentally flawed and recommended that the FDA develop a new pre-and postapproval regulatory pathway to ensure patient safety. 4 The FDA has been working to respond to some of the concerns raised about their evaluation processes.…”