Comments opposing FDA’s draft guidance on postmarket safety and effectiveness data for high-risk devices

Division of Dockets Management (HFA-305)

Food and Drug Administration

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Rockville, MD 20852

Comments of Members of the Patient, Consumer, and Public Health Coalition

on the Draft Guidance

“Balancing Premarket and Postmarket Data Collection

for Devices Subject to Premarket Approval”

Docket No. FDA-2014-D-0090

As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong concerns about the draft guidance for the “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.”

The standards for PMA are currently much lower than for prescription drugs, despite the fact that the 1% of devices approved through the PMA process are life-saving and life-sustaining products, which many prescription drugs are not.  The draft guidance has the potential to lower those standards even more, by increasingly relying on postmarket safety and effectiveness data rather than pre-market data, thus putting patients at greater risk.

The 1% of devices that go through the PMA process are the most risky of the devices that the  FDA defines as “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”[i]

Despite the high risks inherent in ClassIIIdevices, most PMA devices are approved through supplements that do not require clinical trials.  Original PMA clinical trials are often small and short-term, sometimes lacking adequate control groups.  And yet, this draft guidance justifies increased reliance on postmarket studies, potentially lowering the bar for PMA medical devices even further.

The draft guidance states that its purpose is to find “the right balance between premarket and postmarket data collection.”  Unfortunately, it focuses almost entirely on lowering pre-market standards and emphasizing postmarket data, even though the draft guidance admits that, “Greater reliance on postmarket data collection could undermine patient safety if the necessary and timely data collection does not occur.”

Our specific concerns with the draft guidance are:

Least Burdensome

The guidance notes that the FDA’s primary mission is “to protect and promote the public health.”  The draft guidance also notes that the least burdensome provision mandates that FDA not require more or better data than is absolutely necessary to establish effectiveness. The standards for pre-market PMA studies currently have resulted in approval of devices based on very small studies conducted for very short periods of time.   This undermines the public health mission.


The guidance states that, “A reasonable assurance of safety occurs when ‘it can be determined, based upon valid scientific evidence, that the probable benefits…outweigh any probable risks.”   The draft guidance notes that FDA can require postmarket studies “as a condition of approval for devices subject to premarket approval” and that the agency “may take enforcement action” if those conditions are not met.

There are two major flaws related to this section.

1.      Required postmarket studies are not currently conducted in a timely manner. The draft guidance states that postmarket data will be “completed in a timely manner,” but it does not define the term “timely manner.”  The draft guidance further undermines the likelihood that postmarket data will be available in a timely manner when it states that “circumstances may arise…that may adversely affect the ability of the sponsor to complete the post-approval study on time” and that “FDA intends to be reasonably flexible about the timeframe for completing a post-approval study and submitting data to the Agency.”  While that flexibility is certainly appreciated by sponsors, it is very burdensome to patients and their physicians, because it has repeatedly resulted in long delays in the initiation and completion of postmarket studies.  By the time the postmarket studies are completed, the device may have been modified so much that the data are no longer useful.  Meanwhile, thousands if not millions of patients may have been harmed.

2.      Required postmarket studies are often not conducted as was agreed upon, recruiting fewer patients and losing a larger proportion of patients to follow up.   The flexibility that FDA has shown in the past has extended beyond timeliness to the frequent failure of companies to provide meaningful clinical trial data from postmarket studies. FDA rarely penalizes companies for failing to meet their postmarket obligations, blaming patients for their reluctance to participate rather than expecting sponsors to create incentives that guarantee that the studies will be conducted as required and patients will participate in long-term data collection.   In addition to enormous loss to follow-up in breast implant postmarket studies and the failure to complete postmarket studies of gastric lap bands, we would be glad to provide other specific examples where the FDA has failed to enforce postmarket study requirements and then approved new devices or new indications for the same companies, also with postmarket requirements.  There is no reason to assume the company will comply with the new postmarket requirements, since their previous postmarket requirements were not enforced.

We agree that postmarket data should be used to provide additional evidence of safety, such as long-term data or to evaluate very rare risks by studying larger samples.

Unfortunately, the FDA’s track record shows it rarely uses any enforcement mechanisms when companies delay their postmarket studies, fail to conduct them as promised, or fail to complete them.  Until the FDA uses the enforcement mechanisms it has in a consistently forceful manner, the push to postmarket studies is merely a sham.  The result is less useful clinical data, not better postmarket data to supplement weaker premarket data.

Mature Technology

We disagree with the draft guidance recommendation that products with mature technology that have “a robust history of testing and clinical use” can shift more data collection to the postmarket setting.  Unfortunately, new devices often have risks or benefits that are significantly different from previous versions of the same type of device.  For example, hip implants are mature technology but when the devices were modified (classIIImetal-on-metal hips that should have required a PMA) these “mature technology” devices injured thousands of patients unnecessarily, costing Medicare and patients billions of dollars.  Premarket clinical studies would have raised a safety signal on metal-on-metal hips.

Confirm Mitigation Effectiveness 

When the FDA identifies a device risk that it believes can be mitigated through specific strategies, the FDA should require solid scientific evidence that the mitigation strategies are effective prior to PMA approval.  Delaying the collection of such evidence to the postmarket phase would put patients at unacceptable risk.

Conditions of Approval


The draft guidance states, “The labeling of a device approved should include a succinct description of the uncertainty about anticipated benefits and risks and the extent of data that supported approval and required post-approval study(ies).” Patients almost never see the label for a PMA device and many healthcare professionals do not read the labels.  Most patients and physicians erroneously believe that FDA approval means a device has been tested for safety and effectiveness using standards similar to drugs.  If the FDA plans to lower approval standards for high-risk devices, they should use a logo to indicate that.

Postmarket Actions

Safety Communications

We agree with the draft guidance that, “It may be in the best interest of public health for FDA to issue a safety communication,” if post-approval studies raise safety concerns but there is “still a reasonable assurance of safety and effectiveness.”  However, we emphasize that safety communications merely supplement, not replace, evidence of safety and effectiveness and that safety communications not take the place of stronger regulatory actions, such as recalls.

Conclusions and Recommendations

We have strong concerns about this draft guidance, which seems to justify weakening the already weak PMA standards for safety and effectiveness by shifting evidence from premarket studies to postmarket studies.  It could weaken current PMA safeguards for patients, putting them at increased risk of death and disability by justifying the approval of the 1% of riskiest medical devices on the basis of clinical trials that are even smaller, shorter-term, and less conclusive than the current PMA standards.

Patients want access to life-saving devices, not to dangerous, unproven devices that may be less safe and less effective than other available treatments.  In most cases, a few more months of better quality research could result in the timely approval of devices that are proven to be safe and effective at least in the short-term.

American Medical Women’s Association

Annie Appleseed Project

Breast Cancer Action

Center for Medical Consumers

Connecticut Center for Patient Safety

Consumers Union

Jacobs Institute of Women’s Health

National Center for Health Research

Our Bodies Ourselves

The TMJ Association

Women Advocating Reproductive Safety


The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202)223-4000 or at

[i] Food and Drug Administration. Premarket Approval (PMA) Web site.

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