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Homework answers / question archive / The course covered the regulatory framework in the U
The course covered the regulatory framework in the U.S. for medical device development throughout the product lifecycle. We reviewed the different routes to market, quality testing and quality design, device classification, FDA actions, and post-market surveillance.
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Reflection on Regulatory Framework for Medical Device Development
There has been an improvement in medical devices' quantity, variety, and complexity in the last two decades. The need to have a steady regulatory outlook called for an evolution in the modulation of medical devices. This reflective essay intends to look into the history of medical devices regulations, diverse ways to market, test quality and quality design, classification of devices, FDA actions, and post-market surveillance. The purpose is to enlighten me and others on what was studied in class and was not known before.
History of U.S. Medical Device Regulations
In 1906, the Food and Drugs Administration's surveillance began after President Theodore underwrote the Pure Food and Drugs Act. Ever since, Congress has diversified the role of the FDA in safeguarding and enhancing the evolution of drugs and food for humans and animals, medical devices, radioactive products, and cosmetics. By pronouncing the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FFDCA) in the 1960s and 1970s, Congress answered the public's wish to have added surveillance of medical devices. The formation of the Center for Devices and Radiological Health (CDRH) in 1982 resulted from unifying FDA organizational units that modulated medical devices and radioactive products ("A History of Medical Device Regulation and Oversight in the U.S.," 2019).
FDA Regulations and Guidance
FDA advocates the need for electronically registering all establishments belonging to manufacturers or distributors except on FDA waivers. FDA also guides us on listing devices medically, acquiring premarket notification of 510(k), and premarket approval of all Class III devices ("Overview of Device Regulation," 2020). Other regulations included are investigational device exemption, regulation of system quality, labeling, and reporting incidences caused by medical devices.
Classification, Controls, and Examples
Classification of devices is into three classes: Class I, II, and III. Class I devices do not cause probable absurd threat and injury to patients and are modulated by general controls. These devices do not need FDA inspection; instead, FDA assesses them collectively and does not need the welfare and efficacy of the device before launching it to the market. Examples of these devices are surgical equipment that can be handheld, tongue depressors, crutches, among many others.
Class II devices are high-risk devices that pose a significant threat of injury to patients. Due to the nature of these devices, regulation by general control and unique rules to guarantee security and efficacy finds established in FDA. The need for premarket notification 510(k) clearance from FDA ensures that the manufacturer of the device submits proven information that the incoming device corresponds to a lawfully advertised device. Examples of these devices are heart monitors, pumps for infusion, surgical wraps, and Oxygen masks.
Class III consists of devices that support life and assist patients to live longer. These devices are also those regarded with significance as averters of human health impairment. Class III devices are the highest threat to causing disease and harm and are unregulated by general and special controls. To make sure they are safe and efficient premarket approval is needed to launch them. Examples of these devices are life support machines, asystole, heart muscle, cardiac tubes, among others (Gupta, 2016)
Panels, Format of Classification, and Codes of Federal Regulations (CFR)
Title 21 of the CFR, Sections 862-892, provides a match for device description enabling classification. FDA categorized and defined more than 1,700 various devices and grouped them into 16 self-limited “panels” in the CFR Sections 862-892. The panels are according to medical specialty ("Device Classification Panels," 2018). The classification format matches a description, understanding the intended use, indications of use, and, lastly, requirements for marketing the device.
Predicate devices, Substantial Equivalence and 510(k) Application
Predicate devices are medical devices already lawfully marketed in the U.S. The purpose of these devices is to compare with new ones that need the FDA's authentication via clearance by premarket notification 510(k)(PMN). On the other hand, Substantial equivalence authenticates the efficacy and safety of the new device compared to the predicate. In the process of submitting PMN, the individual must have first reached the predicate to the new device to ensure substantial equivalence after that receiving an order that allows device marketing ("Premarket Notification 510(k)", 2020).
IDEs and Clinical trial requirements
Investigational device exemption permits the device under investigation to be used in clinical trials to evaluate its efficacy and safety. The requirements for this process are IDE's approval by the FDA, a plan of inquiry approved by the institutional review board, data-based permission from all patients, a label specifying the device for investigational use, supervision of the trials, and needed records and reports.
PMA, FDA’s Action and Importance of meeting and Communication
PMA requires a new device with substantial equivalence and exemption of the investigational device. After a PMA receipt is issued, the FDA determines the completeness of the application, files the application, and informs the applicant of the filing in 45 days. One hundred eighty days later, the review commences. On rejection of the application FDA due to inadequacy it issues a reference number and alerts the applicant of the filed resubmission. The applicant after that gives more data or chooses to hold a meeting with the director of device evaluation's office to review the decision. If the applicant is unsatisfied with the review, appealing to the director of CDHR is allowed for a final verdict (Van Norman, 2016).
Combination Medical Devices and Primary Mode of Action
Combination medical devices are devices that have a variety of either a biologic or drug or both. The mode of primary action is to perform a biological evaluation on the components combined device (Tian et al., 2021)
Importance of Communication and Meetings
The importance of communication during submissions, as derived from (Van Norman, 2016), is to keep up to date with the applications' proceedings and submit any relevant information following rejection due to insufficiency. In the case of PMA, meetings are essential for seeking clarification and raising issues on rejected applications.
Conclusion
In summary, in my reflection above, I have understood the history of U.S. medical device regulations. The course outline has made me comprehend medical devices, classifications, controls, and examples. Also, I have learned the different ways and requirements of marketing per the FDA rules. This reflective essay enables me to adhere to the rules and regulations of the FDA in the manufacturing and distribution of medical devices. I will apply this knowledge in the use of the devices and report incidences caused by medical devices.
Reflection paper
In the last two decades, there has been an improvement in medical devices' quantity, variety, and complexity. The need to have a steady regulatory outlook called for an evolution in the modulation of medical devices. On this ground, I choose to reflect on the regulatory framework and its impact on ensuring that medical devices are safe and efficient, as learned in this course. I will also reflect on how the knowledge gained from this course will benefit me in my career as a caregiver.
The history of medical devices regulation has opened me up to insights regarding the role of the FDA in the regulation of medical devices. It has given me the genesis of the Center for Device and Radiological Health. This body is responsible for modulating medical devices and radioactive products ("A History of Medical Device Regulation and Oversight in the U.S.," 2019). The guidelines outlined by the FDA regarding regulations have helped me understand that there is a need to register establishments and list the devices for easier access and review where need be. I also learned the importance and requirements for premarket notification 510(k) and premarket approval in marketing and launching a product. In establishing a new product, I now know the regulation of system quality, labeling, and exemption of investigational devices ("Overview of Device Regulation," 2020). The emphasis on reporting incidences caused by these devices will ensure safety both for the patient and me as the caregiver.
This course has also helped me classify medical devices regarding risk, indications of use, intention, and controls needed. In my field of practice, I will be exposed to all three classes of medical devices to offer care and sustain lives. The insight into which category of the device causes more harm allows me to be keen on the indications and intent of use to avoid causing damage or injury to a patient. To classify my device, Title 21 Section 862-892 of the CFR gives me a description that will match the device I want to classify through the 16 medical specialty panels ("Device Classification Panels," 2018).
I realize that any device I use in the second class of classification has gone through the process of comparison between a lawfully marketed device (Predicate) and the new device, attained a Premarket Notification 510(k) clearance to guarantee safety and efficacy (substantial equivalence). I am also aware of the combination of medical devices, a combination of device/drug, device/biologic, or device/biologic/drug (Tian et al., 2021).
To add on, I have learned that the submission of PMA and PMN 510(k) (Van Norman, 2016) requires communication to keep the applicant up to date with the proceedings and submit more information in case of insufficiency. On the other hand, Meetings allow for complaints and reviews on verdicts ensuring satisfaction to the applicant. The knowledge acquired will have an enormous impact on my use, distribution, marketing, and classification of medical devices. I will adhere to statutory laws ensuring that I will not lose my licensure or be an accomplice for not reporting incidences.
Conclusively, I have gained much knowledge that I didn’t have from this class, and I believe this knowledge will positively impact my nursing practice.
