Q&A FROM FDA REGARDING MEDICAL DEVICES

NEWS CENTER Maine (NCM) sent a list of questions to the FDA and these were their responses:

NCM: What steps is the agency taking to address the concerns about the fact that 70-percent of the
medical devices approved in the U.S. through the 510(k) process – about 18-thousand annually are not
tested in people?

FDA: The Pre-market Notification (510(k)) Program is the most common pre-market review regulatory
pathway for new devices received in the Center for Devices and Radiological Health (CDRH). In 2017, FDA
cleared 3,173 devices through 510(k), making up 82% of the FDA’s cleared or approved medical devices.

FDA: We believe firmly in the merits of the 510(k) process. We’re working on efforts to ensure that the
510(k) program is keeping pace with the important innovations we’re seeing in device development.

FDA: The FDA may require extensive testing for devices that are cleared through a 510(k), and we
generally require more evidence for more complex technologies. Because most devices, unlike drugs, are
hardware and have localized effects on the body, robust non-clinical testing can demonstrate that a device
performs similarly to comparable devices already on the market and that its benefits outweigh its risks. And
we can often get this information without subjecting patients to clinical trials. When appropriate, we do
require clinical studies for certain devices subject to a 510(k).

FDA: PMA is the most rigorous type of device marketing application required by the FDA, and is
appropriate for higher risk devices where general and special controls are not sufficient to provide
reasonable assurance of safety and effectiveness of the device. However, the PMA pathway is not
appropriate for all medical devices. Requiring a PMA for lower risk devices that are similar to other devices
already on the market—those eligible for a 510(k)—would not necessarily provide better patient safeguards,
but would result in unnecessary costs and delays while diverting FDA staff resources away from studying
and evaluating higher-risk and novel devices.

FDA: In a recent 2018 report, we discuss in detail efforts we’ve taken to strengthen the 510(k) program,
including eliminating the use of 1,758 devices as predicates, how 30% of 510(k) submissions are not
accepted for initial review, a 150% increase in the number of pages for each 510(k) since 2009, that FDA’s
staff spend more time reviewing each 510(k) submission than ever before yet continue to meet required
performance timelines, and the publishing of more than 50 final and cross-cutting guidances and device-
specific guidance documents to help improve predictability, consistency, and transparency of submission
content while clarifying expectations, policies, and procedures surrounding review of 510(k) submissions.

NCM: There is also criticism about the fact how doctors aren’t required to report complications from
medical devices to the FDA, to the information the agency it receives is very likely incomplete. Are
there going to be new guidelines to improve the reporting process on adverse reports on medical
devices between providers and the FDA?

FDA: As established by federal law, mandatory reporters (i.e., manufacturers, device user facilities, and
importers) are required to submit certain types of reports for adverse events and product problems to the
FDA about medical devices. A “device user facility” is a hospital, ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. In addition,
the FDA also encourages health care professionals, patients, caregivers and consumers to submit
voluntary reports about serious adverse events that may be associated with a medical device, as well as
use errors, product quality issues, and therapeutic failures. These reports, along with data from other
sources, can provide critical information that helps improve patient safety. However, Medical Device
Reporting (MDR) is only one of the postmarket surveillance tools the FDA uses to monitor device
performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of
these products. We also use other sources such as reports from our MedSun Hospital Network, data from
mandated post-market studies, and data from other sources such as scientific literature, health care claims,
patient registries or other agencies.
FDA: We’re also working to implement an active surveillance system called the National Evaluation System
for health Technology (NEST). Active medical device surveillance will better protect patients by
continuously generating, accessing, and evaluating large data sets on device performance and clinical
outcomes associated with device use in routine clinical practice. It also improves the FDA’s ability to link
adverse events with specific devices, so we can act quickly with manufacturers and healthcare providers to
make timelier, evidence-based decisions to mitigate device problems and keep patients safe.

NCM: According to the FDA spinal cord stimulators account for the third highest medical device
injuries—more than 80-thousand since 2008. What is breakdown of adverse per manufacturer? How
many reports are related to devices manufactured by Boston Scientific? Is the agency considering
taking account in light of the high amount of injury reports?

FDA: The FDA has carefully reviewed the adverse event reports related to spinal cord stimulators. In
addition, as part of the FDA’s Medical Device Report (MDR) regulations, manufacturers are required to
evaluate each complaint to determine if it represents an MDR reportable event, which includes evaluating
the cause of the event. The manufacturer is also required to submit, in a supplemental report, any required
information that was not available at the time it filed its initial report. These supplemental reports include
any information that it obtained by analysis, testing, or other evaluation of the device. The agency uses a
risk-based approach and considers multiple sources of information (not just adverse event reports) to
identify issues that need further action.

FDA: The FDA will continue to closely monitor the adverse events reported for spinal cord stimulators and
all devices and will communicate to the public any concerns as appropriate.

FDA: You can get more information on adverse event reports by searching our public MAUDE database
(link below). You can search by device name or manufacturer in a date range that you choose.