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Medical Device Regulation: Safety over Speed

July 03, 2015

Medical devices are an essential part of today’s health care system. From life-saving technologies such as heart valves to screening tools such as x-rays, the field of medicine relies on medical devices to diagnose and treat patients with a wide variety of ailments.

By Jenny Markell, CAS ’16, 

The 20th century contained several tragedies due to faulty medical devices. For example, in the early 1970s, the Dalton Shield IUD led to the hospitalization and, in some cases, death of many women.[1] Concerned about the safety and efficacy of medical devices, in 1976, Congress enacted the Medical Device Amendments, giving the Food and Drug Administration (FDA) the authority to review proposed devices to ensure that they were safe and effective.[2] In regulations it adopted to implement the statute, the FDA established three different classes of medical devices: Class I, II, and III devices, with Class I devices having the lowest potential of risk to the patient and Class III devices having the highest risk to patients.

Today, there is considerable political pressure to expedite the approval process. Pressure to hasten the approval process comes in part from complaints regarding long delays to FDA approval or clearance. A study by medical device consulting group Emergo concluded that “over the last 15 years, the FDA has been taking progressively longer to clear 510(k) submissions (one type of medical device clearance)…[with] a company submitting a 510(k) today [having] a 22 percent chance of getting it cleared within 3 months, and a 61 percent chance of getting it cleared within 6 months.”[3]

The 21st Century Cures Bill, which the House Energy and Commerce Committee recently passed unanimously, proposes a faster approval process for medical devices in addition to expediting the review process for pharmaceuticals. Representative Fred Upton, Chairman of the House Energy and Commerce Committee, stated on behalf of the committee that “health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era…when our laws don’t keep pace with innovation, we all lose.”[4] Yet, while it aims to encourage innovation, the proposed measures will negatively affect present safety and efficacy standards.

Currently, the FDA reviews medical devices through several different methods established by the 1976 Medical Device Amendments, including Premarket Approval (PMA) and the 510(k) process. When the FDA uses PMA, the more extensive process, device companies demonstrate safety and efficacy with clinical trials in order to receive “FDA approval.”[5] PMA is utilized for the riskiest devices (Class III devices), which are defined as “implanted and life-supporting or life-sustaining devices.”[6] It requires the review of evidence from clinical trials, which are recognized to offer the best scientific proof of safety and efficacy.

In contrast, the relatively abbreviated 510(k) process, which is supposed to be utilized for devices (often Class II, or moderate risk devices) “substantially equivalent” to those already on the market, is a much shorter process resulting in FDA clearance.[7] As they do not require further proof of safety and efficacy, 510(k) submissions allow device companies to avoid both the large expenses and lengthy process associated with clinical trials while still getting their device on the market. Class I devices are normally exempt from this regulatory process due to their low risk of harm.

The 21st Century Cures Bill proposes to change current medical device legislation in several ways. First, when companies are proposing new devices that they claim are “substantially equivalent” to devices already on the market, the proposed bill allows for a third-party (paid by the device company) to determine whether or not the safety and efficacy standards have changed and what type of approval the device needs to undergo, rather than have the FDA do so - as is currently required. The FDA should keep the right to decide what type of approval process the device goes through, rather than rely on a paid third party with financial interest in the device company. 

Additionally, the bill proposes expediting approval for the riskiest devices by cutting back on the PMA process. Section 2222 would allow Class III Medical Devices to be approved based on case studies of only one or two patients instead of by randomized clinical trials.[8]  Harvard Medical School colleagues Dr. Jerry Avorn and Dr. Aaron Kesselheim describe these “nontraditional study designs and methods of data analysis to further speed approvals” as problematic[9] because relying on case studies rather than randomized clinical trials will not allow for scientific proof of safety and efficacy. Doctors Avorn and Kesselheim have suggested that, contrarily to the committee’s goal of improving our “outdated” approval process, these efforts to expedite approval “could actually bring back some of the problems we thought we had left behind in the 20th century” by reducing quality standards. [10] Similarly, President of the National Center for Health Research Diana Zuckerman states that by “roll[ing] back patient safeguards, [this bill would] leave an FDA that looks more like the one that existed in the 20th century, not one worthy of the 21st.” [11]

While the House Energy and Commerce Committee is striving to encourage innovation in the medical field, expediting premarket review for risky medical devices may lower safety and efficacy standards. As noted by former FDA official Richard Williams, “if the goal [as stated by the Energy and Commerce Committee] is to ‘accelerate the pace of cures and medical breakthroughs in the United States,’” then it may be better to critically examine our current process rather than add new mechanisms of approval on top of the old ones.[12]

FDA Report – Medical Device Recall

Figure 6: CDRH Recall Counts by Fiscal Year and Class[13]

CDRH Recall Counts by Fiscal Year and Class

  [1] “History of Federal Regulation: 1902-Present.” FDAReview.org, a Project of The Independent Institute. Accessed June 15, 2015. http://www.fdareview.org/history.shtml.

  [2] “Overview of Medical Devices and Their Regulatory Pathways. U.S. Food and Drug Administration. Last modified March 6, 2014. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm.

  [3] “How long it takes the FDA to ‘approve’ a 510(k) submission.” Emergo Group. Accessed June 15, 2015. http://www.emergogroup.com/resources/research/fda-510k-review-times-research.

  [4] “21st Century Cures Bill Proposes Breakthrough Medical Device Program, Expanded HDEs.” http://www.meddeviceonline.com/doc/st-century-cures-bill-proposes-breakthrough-medical-device-program-expanded-hdes-0001.

  [5] “Premarket Approval (PMA).” U.S. Food and Drug Administration. Last modified August 19, 2014. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/.

  [6] Department of Health and Human Services, U.S. Food and Drug Administration. Title 21 – Food and Drugs, Part 860 – Medical Device Classification Procedures. 21CFR860.3. Revised as of April 1, 2014. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=860.3.

  [7] “Premarket Notification 510(k).” U.S. Food and Drug Administration. Last modified February 24, 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm.

  [8] “Let Congress know how you feel about unsafe medical products!” National Center for Health Research. Accessed June 20, 2015. http://center4research.org/public-policy/letter-to-congress-21st-century-cures/.

  [9] Avorn, Jerry and Aaron S. Kesselheim. “The 21st Century Cures Act – Will It Take Us Back in Time? New England Journal of Medicine 372 (2015): 2473-2475. Accessed June 25, 2015. doi: 10.1056/NEJMp1506964.

  [10] Ibid.

  [11] Gonsalves, Gregg and Diana Zuckerman. “Commentary: Will 20th century patient safeguards be reversed in the 21st century?” 350 (2015). March 25, 2015.  doi: http://dx.doi.org/10.1136/bmj.h1500.

  [12] Williams, Richard. “Healthcare cures and innovation for the 21st century.” TheHill. May 29, 2015. Accessed June 15, 2015. http://thehill.com/blogs/congress-blog/healthcare/243377-healthcare-cures-and-innovation-for-the-21st-century.

  [13] Food and Drug Administration, Center for Devices and Radiological Health. “Medical Device Recall Report: FY2003 to FY2012.” http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM388442.pdf.


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