7-3 FDA Legislation Paper
IHP 600
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The United States Food and Drug Administration (FDA) goes back to 1906 where it
first began as Pure Food and Drugs Act (FDA.gov,2018). The FDA legislation is an
important aspect in health care as well as in patient safety. The FDA has eight legislative
compartments that service within the healthcare community for patient safety and
treatments. The Safe Medical Devices Act and the Food and Drug Administration
Modernization Act will be discussed. Each of these legislations along with the others work
together to benefit patients.
The Safe Medical Devices Act (SMDA) of 1990 was implemented so that all
injuries and deaths resulting from medical devices were properly reported. This required
ambulatory surgery centers, hospitals, outpatient diagnostic centers, and other user facilities
to report all incidents in which a medical device or user error may have caused or
contributed to the death, serious injury, or serious illness of a patient (Schremp,1992). There
are three classes of devices that are covered by the legislation to regulate devices. Table 1
summarizes the three different device classifications.
Class I
- Poses the lowest risk; requires general
controls regarding fraudulent claims
Class II
Subjects to labeling and performance
standards and post-market surveillance
Class III
Devices that support life or present a
potential risk of illness or injury;
requires premarket approval regarding
safety and effectiveness.
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Table 1: Summarization of device classes (Shiu, 2017).
According to the FDA website, “Medical Device Reporting (MDR) is one of the
post market surveillance tools the FDA uses to monitor device performance, detect potential
device-related safety issues, and contribute to benefit-risk assessments of these product
(FDA.gov, 2022). The FDA has made device malfunction reporting very convenient by
thoroughly explaining ways patients can report device malfunctions either “by mandatory
reporters (manufacturers, importers and device user facilities) or voluntary reporters (health
care professionals, patients, caregivers and consumers)” (FDA.gov, 2022). Although the
FDA has presented these places to report device malfunctions, they also have several phone
numbers online if a person is having difficulty locating a place or person to report to.
Facilities must report every incident in which a device may have caused or contributed to a
patient or employee's death, or serious injury or illness and other significant adverse
experiences determined by the FDA (Punchatz, 2017). In 1990, the SMDA was expanded to
include the FDA’s regulatory role in the collection of data. This was a preventive measure
to ensure patients were not exposed to potentially harmful devices.
Reports filed under the SMDA are publicly available under the Freedom of
Information Act with private information being omitted from the reports. With the growth
of technology in the medical field, safety of the patient is the primary concern. It is very
important that these technological devices meet or even exceed the standard regulation
expectations. The Investigational Device Exemption (IDE) is for devices that are used
during a clinical study in order to collect safe and effectiveness data to support a Premarket
Approval Application (Center for Devices and Radiological Health, 2017). aa Once a clinical
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study has concluded, the device can be classified under one of the three categories based on
the results.
On a side note, the FDA will not disclose the existence of an IDE because the
information is considered confidential (Center for Devices and Radiological Health, 2017).
A heart valve is an example of a medical device that needed FDA approval before being
used by cardiologist to operate on patients. The heart valve is used by patients who need a
replacement of a diseased, damaged, malformed, or malfunctioning heart valve (Heart valve
disease clinical trials, n.d.). Physicians and researchers in New York University’s Langone’s
Division of Adult Cardiac Surgery conducted clinical trials to find more effective treatments
for patients with heart valve conditions, and in order to get the treatment approved by the
FDA, these clinical trials provide evidence for the FDA to take note of for it to gain
approval for the general public (Heart valve disease clinical trials, n.d.). Without clinical
trials, medical devices cannot be improved upon or used in the public market.
The Food and Drug Administration Modernization Act (FDAMA) of 1997 amended
that the federal food, drug, and cosmetic act. This legislation regulates food, drugs, devices,
and biological products by the FDA. More recently, the FDA Modernization Act was
updated in 2021 and was implemented to amend the Federal Food, Drug, and Cosmetic Act
to allow manufacturers and sponsors of a drug to use alternative testing methods to animal
testing to investigate the safety and effectiveness of a drug, and for other purposes.
According to JS James, “The legislation allows fast track review for the most important
drugs. It also allows drug companies to promote off label use of already-approved
pharmaceuticals for other purposes. The controversial issue allows drug companies to
provide physicians with documentation on the effectiveness of their drugs in treating other
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conditions. The industry supports the change since the revenue growth for off label use of
drugs is especially important for smaller biotechnical companies, while consumer groups
fear that it is a loophole for selling unproven drugs. The bill also renews the Prescription
Drug User Fee Act (PDUFA), regulating the current practice of compounding, and
monitoring medical devices and health care claims for foods” (James, 1997).
An example of the effect of the 1997 FDA Modernization Act is that insulin and
antibiotics no longer needed batch certifications. Antibiotics and Insulin could now be sold
over the counter without a doctor’s prescription. FDAMA 1997 also abolished prohibition
against dissemination by manufacturers of information about unapproved uses, such as off
label brands. This allowed new establishments to form standards and organization within the
FDAMA of 1997. The three categories that fell under FDAMA 1997 were improving
regulation of drugs, improving regulations of devices, and improving regulations on food.
All these categories play an essential key role on the safety of medication, medical devices,
and food before they are accessed by the general population.
Today, both FDAMA and SMDA play a huge role in the safety of public health
within the United States. As the technological world is advancing especially within the
medical field, the ability of SMDA to monitor the negative impacts that these medical
devices may have on patients after they have been released gives a sense of reassurance
that the government cares. Especially during the pandemic, when COVID 19 impacted the
entire world, there was a rise in demand for CPAP (Continuous Positive Air Pressure) and
BIPAP (Bilevel Positive Air Pressure) machines. These machines are ventilators that help
the patient breath especially since a lot of people who contracted the virus complained of
shortness of breath. These monitors are extremely beneficial especially since patients can
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use them from the comforts of their home and the best part is that they require very little
maintenance. With SMDA closely monitoring machines and setting expectations, these
ventilators are a perfect example how beneficial these devices were in the amidst of the
pandemic. aa
FDAMA on the other hand has a bigger influence since it regulates a larger variety
of things within the United States. Today, FDAMA showed it is extremely beneficial even
during the pandemic. Paxlovid, an antiviral drug that is used to help with Covid symptoms
was issued an emergency use of authorization just last year. Many people were prescribed
this medication and saw positive results. Despite the rapid approval, clinical trials and
therapies are still being conducted for the drug. Infact many of the trials are already
showing promising results (FDA.gov, 2021). Although not every treatment may work on all
individuals, not all medical devices may benefit everyone, or not all medications may be
suitable for everyone, the legislations put into place give us a sense of security that they are
thoroughly monitoring trials to make sure the medications, medical devices, food, etc.
available to the public will not harm us.
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References:
1. FDA. (2018, March 28). When and why was FDA formed? Retrieved from
https://www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed
2. Shremp, P.S. (1992, September). Risk Management. Retrieved from:
http://www.omic.com/safe-medical-devices-act-reporting-requirements-and-risk-
management-concerns/
3. Shi, Leiyu, (2017). Essentials of the U.S. health care system. Burlington,
Massachusetts :Jones & Bartlett Learning,
4. FDA. (2022, Feb 18). Medical Device Reporting (MDR): How to Report Medical
Device Problems. Retrieved from: https://www.fda.gov/medical-devices/medical-
device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
5. Center for Devices and Radiological Health. (2017, December 29). Consumers
(Medical Devices) - Learn if a Medical Device Has Been Cleared by FDA for
Marketing. Retrieved from
https://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm
6. Punchatz, I. J. (2017, July 07). Users Facilities Requirements Under the Safe
Medical Devices Act. Retrieved from https://corporate.findlaw.com/litigation-
disputes/users-facilities-requirements-under-the-safe-medical-devices-act.html
7. Heart valve disease clinical trials. NYU Langone Health. (n.d.). Retrieved from
https://med.nyu.edu/departments-institutes/cardiothoracic-surgery/division-adult-cardiac-
surgery/heart-valve-disease-clinical-trials
8. James JS. FDA reform signed into law. Food and Drug Administration. AIDS Treat
News. 1997 Dec 5;(No 284):6-7. PMID: 11364915.
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