7-3 FDA Legislation Paper
IHP 600
2
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.
Table 1: Summarization of device classes (Shiu, 2017).
3
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). b Once a clinical study has concluded, the device can
be classified under one of the three categories based on the results.
4
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 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
5
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 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. b
6
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.
7
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.
