A disposable pacemaker regulates the heartbeat, then dissolves into the body a few weeks later. A continuous glucose monitor worn under clothing reads blood sugar all day without a finger stick. Neither was possible ten years ago. Device technology has moved quickly.
With that rapid growth, comes responsibility.
Federal Oversight for Medical Devices
The Food and Drug Administration oversees the medical device industry in the United States. Its role runs from device inception through development, production, marketing, and public use, with the aim of keeping the end user safe. Maintenance and repair fall under it as well, so that devices keep working as intended once they are in the field.[1]
Medical devices must be used for their purpose or intent.
The World Health Organization estimates roughly 2 million medical devices are on the market worldwide. The FDA regulates more than 6,500 categories of them.[10]
This sector accounts for some 2 million jobs in the U.S.
The United States is the largest medical device market. It stood at $156 billion and was projected to reach $208 billion by 2023.[8]
What Types of Medical Devices Does the FDA Regulate?
The FDA regulates a wide variety of medical devices that include, but are not limited to
The overall objective of government oversight is to maintain maximum medical device safety and efficacy, while fulfilling personal treatment objectives.
Federal guidelines are designed to
- • Reduce the number of adverse events and negative reactions
- • Improve efficacy by ensuring products are safe
- • Help further medical treatment for custom use
- What Affects the Product Safety of Medical Devices?
Several factors impact product safety and efficacy of medical devices.
• The genetic make-up of the patient and end-user
• The overall physiologic condition of a patient
• Manufacturing and labeling of the medical device
• Appropriate use of the medical device
• Follow up and monitoring for adverse events[7]
Bringing a new device to market is a long process, and the federal and international controls around it are unforgiving for a company doing it for the first time. Hiring outside specialists for the early work is usually cheaper than learning the process on your own submission.
Medical Device Regulatory Compliance-Training and Study
How are staff educated and trained to handle compliance requirements for medical devices?
These specialists work inside the regulatory framework to get devices to a standard that satisfies safety and efficacy requirements in the United States and abroad. The training behind that covers regulatory requirements, the submissions process, compliance through every phase of development both pre and post market, and the rules that apply in other markets.
The standard course of study for Regulatory Affairs Specialists includes coursework in
- Pre-market notification 510(k) process
- Planning and Submission for Pre-market approval (PMA)
- Requirements for Global vigilance
- Requirements in the European Union, Canada, Asia, and Latin America[9]
The FDA works to keep every device registered in the United States, including those exported elsewhere, safe and effective across its whole lifecycle. Maintenance, repair, and servicing matter here too, because a device that degrades in the field stops being the device that was approved.
Manufacturing and Production Compliance
The Food and Drug Administration regulates all aspects of the manufacturing process including, device design and validation along with good manufacturing practices.
Quality System Regulations (QSR)
Quality System Regulations cover device design, its validation, and good manufacturing practice. They also govern how complaints are investigated and how performance is monitored once a device is in use. The FDA works with manufacturers on meeting these requirements, and enforces them where it has to.
The FDA Regulatory Department for Medical Devices
Some regulatory controls mandated by the FDA apply to all medical devices. These controls consist of:
Devices deemed unsafe when properly used per instructions
The FDA is limited however, in its role to regulate those who purchase and use medical devices for their patients or consumer clients.
The FDA cannot regulate individual medical practice, or the physicians, nurses, nurse practitioners, medical assistants, hygienists, and technicians who administer treatment using a medical device.
The FDA cannot limit what medical practitioners tell their patients surrounding the use of medical devices and associated therapies.
The FDA cannot recommend products or medical devices for physicians, healthcare clinics, or home healthcare agencies.
The FDA is prohibited from rating individual medical devices and/or sharing such information with medical personnel.[1]
Medical devices are classified based on the level of possible risk posed to the end user.
Classifications are as follows
Because of the potential for harm, regulatory control tightens as the class rises. Class I devices carry the lightest requirements and class III devices the heaviest.[6]
The Federal Food Drug and Cosmetic Act called for Medical Device Amendments in the mid 1970s. Some devices predate those amendments and can be reclassified if new information emerges about their safety or efficacy.[4]
A midsize company can close that gap by bringing in people who have run these processes before rather than building the capability from scratch. They already know the sequence of procedures around FDA approval and what follows it.
Steps to Medical Device Approval
The FDA requires several steps to bring a medical device to market.
Device Registration and Listing
MAUDE (Manufacturer and User Facility Device Experience) Database
Submit Adverse Event and Problem Reports (MDR)
Find Device Approvals and Clearances[2]
Premarket Submission-Substantial Equivalence
If the device is exempt from the Premarket Approval Application, a premarket notification 510(k) goes to the FDA instead, and the burden of Substantial Equivalence has to be met. A device is substantially equivalent if it is similar to an existing technology that has already been legally marketed.
Premarket approval is the most demanding stage of the whole process. The core task is producing scientific evidence that the benefits to health outweigh the potential for harm.
Premarket approval also has to show that the device stands to help a meaningful share of the population it is intended for, not simply that it performs safely in a narrow test.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is a division within the U.S. Food and Drug Administration. The CDRH oversees federal regulation of companies who deal with:
Importation of medical devices into the U.S.
Regulatory Requirements for Manufacturers
Manufacturer requirements for medical devices that are distributed in the United States include
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
- Investigational Device Exemption (IDE) for clinical studies
- Quality System (QS) regulation
- Medical Device Reporting (MDR)
The following types of companies/contractors must list their medical devices with the Food and Drug Administration
Re-processors of single-use devices
Manufacturers of accessories and components sold directly to the end user
U.S. manufacturers of “export only” devices
Many US companies export devices worldwide. Where another country is involved, they generally work through local distributors who understand the regulatory controls in that market.[3]
Privacy and Security Standards
In efforts to protect the privacy of patient information, as well as the security of individual accounts and devices, regulatory action continues to evolve.
Patient confidentiality around device use matters, but there are cases where a healthcare provider may release personal medical information to a device company without the patient's prior written consent. That applies where the device is necessary for medical care and forms part of the patient's treatment plan.
Emerging Regulatory Controls-Cybersecurity Threat
One recurring criticism of the approval process is that it does not always require a full series of clinical trials. The United States and the European Union both manage product safety through a mix of premarket submission and postmarket surveillance. Non-clinical risks remain, particularly with networked devices. The FDA has proposed regulatory action against cyber attacks on them. Pumps, pacemakers, and heart monitors can all be reached. By intercepting traffic between a device and its server, an attacker can change how the device behaves, with direct consequences for the patient.[7]
As medical device technology continues to rapidly expand, the need for greater regulatory oversight will most certainly be necessary moving forward.
1Center for Devices and Radiological Health. (n.d.). FDA's role in regulating medical devices. U.S. Food and Drug Administration. Retrieved November 27, 2021, from
https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices.
2Center for Devices and Radiological Health. (n.d.). Medical devices. U.S. Food and Drug Administration. Retrieved November 27, 2021, from
https://www.fda.gov/medical-devices.
3Center for Devices and Radiological Health. (n.d.). Overview of device regulation. U.S. Food and Drug Administration. Retrieved November 27, 2021, from
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation.
4Center for Devices and Radiological Health. (n.d.). Overview of medical device classification and reclassification. U.S. Food and Drug Administration. Retrieved November 27, 2021, from
https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification.
5Center for Devices and Radiological Health. (n.d.). Quality and compliance (medical devices). U.S. Food and Drug Administration. Retrieved November 27, 2021, from
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices.
6Medical device user fee rates for fiscal year 2011. (n.d.). Retrieved November 27, 2021, from
https://www.federalregister.gov/documents/2010/08/03/2010-19038/medical-device-user-fee-rates-for-fiscal-year-2011.
7Medical product safety. Medical Product Safety | Healthy People 2020. (n.d.). Retrieved November 27, 2021, from
https://www.healthypeople.gov/2020/topics-objectives/topic/medical-product-safety.
8Medical technology spotlight. Medical Technology Industry Spotlight | SelectUSA.gov. (n.d.). Retrieved November 27, 2021, from
https://www.selectusa.gov/medical-technology-industry-united-states.
9Regulatory requirements for medical devices. UCI Division of Continuing Education. (n.d.). Retrieved November 27, 2021, from
https://ce.uci.edu/courses/sectiondetail.aspx?year=2020&term=FALL&sid=00173.
10World Health Organization. (n.d.). Medical devices. World Health Organization. Retrieved November 27, 2021, from
https://www.who.int/health-topics/medical-devices#tab=tab_1.