FDA Oversight for Medical Devices—Insight into Regulatory Process

A disposable pacemaker regulates the heartbeat before dissolving into the body several weeks later. A continuous glucose monitor (CGM) worn under clothing tests blood sugar throughout the day without the need for a finger stick. Just ten short years ago, these technologies would not have been possible. Medical device technology has rapidly evolved over the past few years.

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. From device inception to development, through production, marketing, and public use, the FDA works to ensure safety for the end user. Maintenance and repair involve the FDA as well, so that devices are effective in their use, and add value to the quality of life for consumers.[1]

Medical devices must be used for their purpose or intent.

Medical Devices—Fast Facts

Today, the World Health Organization estimates roughly 2 million medical devices are currently on the market, globally. The United States Food and Drug Administration regulates more than 6,500 medical device categories.[10]

This sector accounts for some 2 million jobs in the U.S.

The largest medical device market belongs to the United States. At $156 billion, the market is expected to grow to $208 billion by the year 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:

• Diagnostic Tests

• Bandages

• Contact lenses

• First aid kits

• Pacemakers

• Surgical instruments

• Blood glucose meters[5]

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.

These include:

• 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]

Outsourcing for Startups

Medical device manufacturers often struggle to navigate the rigorous process of bringing a new medical device to market. Federal and international controls make compliance within strict regulatory guidelines challenging for companies new to the medical device manufacturing landscape. Hiring third-party professionals to do the initial heavy lifting makes sense.

Medical Device Regulatory Compliance—Training and Study

How are staff educated and trained to handle compliance requirements for medical devices?

Professionals work within regulatory guidelines to ensure medical devices meet with compliance standards for safety and efficacy, both in the United States and abroad. Coursework for those in the field of medical device compliance covers regulatory requirements, the submissions process, compliance during all phases of medical device development, both pre and post-market phases, and international markets as well.

The standard course of study for Regulatory Affairs Specialists includes coursework in:

Initial device classification

Pre-market notification 510(k) process

Planning and Submission for Pre-market approval (PMA)

Requirements for Global vigilance

Labeling requirements

Requirements in the European Union, Canada, Asia, and Latin America[9]

Protecting the End User

The FDA works to ensure all medical devices registered in the United States and exported to other countries, are both safe and effective throughout the entire product lifecycle. Maintenance, repair, and servicing of medical devices is important as well, to guarantee the highest quality of medical care to patients within the United States and abroad.

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 address the design of a device, its validity, and good manufacturing practices. Quality System Regulations investigate complaints and explore new ways to surveil the performance of a medical device. The Food and Drug Administration works closely with medical device manufacturers to ensure all regulatory compliance is met. The FDA also works to enforce regulatory guidelines.

The FDA Regulatory Department for Medical Devices

Some regulatory controls mandated by the FDA apply to all medical devices. These controls consist of:

Prohibited Contamination

Container Contamination

False Claims of Compliance

False or Misleading Labeling

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 practices, physicians, nurses, nurse practitioners, medical assistants, hygienists, technicians, or other medical personnel who may administer some type of treatment or therapy 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:

I Low Risk

II Moderate Risk

III High Risk

Because of the potential for human harm, regulatory controls over medical devices become stricter as the class increases. Class I devices are subject to the least amount of regulatory control, while class III devices require the greatest.[6]

Reclassifying Medical Devices

The Federal Food Drug and Cosmetic Act called for Medical Device Amendments in the mid 1970’s. Some devices however predate the amendments and may be subject to reclassification based on “new information” gathered about the medical device and its safety or efficacy.[4]

Streamlining for Growth

Advancing a midsize company is possible with the help of a trained team of experts available to fill positions necessary to streamline effective quality and regulatory processes. Professional personnel navigate the many procedures associated with FDA approval and follow up.

Steps to Medical Device Approval

The FDA requires several steps to bring a medical device to market.

These include:

• Premarket Notification
• Device Registration and Listing
• Product Code Classification
• MAUDE (Manufacturer and User Facility Device Experience) Database
• Register and List
• Label a Device
• Submit Adverse Event and Problem Reports (MDR)
• Study and Market a Device
• Find Device Approvals and Clearances[2]

Premarket Submission—Substantial Equivalence

If the device to be marketed is exempt from the Premarket Approval Application a premarket notification 510(k) must be made to the FDA and the burden for Substantial Equivalence (SE) must be met. A device is considered substantially equivalent if it is similar to an existing technology that has been previously, legally marketed.

Premarket Approval (PMA)

The premarket approval phase is the most in-depth of the entire medical device approval process. The most important task is to produce scientific evidence that demonstrate that the benefits to health and wellness are greater than the potential for harm.

Secondly, premarket approval is designed to ensure that the proposed medical device has the potential to help a large portion of the population targeted for its use.

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:

Manufacturing

Repackaging

Relabeling

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:

• Establishment registration
• Medical Device Listing
• Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
• Investigational Device Exemption (IDE) for clinical studies
• Quality System (QS) regulation
• Labeling requirements
• Medical Device Reporting (MDR)

Medical Device Listings

The following types of companies/contractors must list their medical devices with the Food and Drug Administration

• Manufacturers
• Contract manufacturers
• Contract sterilizers
• Re-packagers and re-labelers
• Specification developers
• Re-processors of single-use devices
• Remanufacturers
• Manufacturers of accessories and components sold directly to the end user
• U.S. manufacturers of “export only” devices

Global Support

Many U.S. companies export medical devices around the world. In these instances, where other countries are involved, U.S. companies try to work with local distributors that will help the United States to effectively navigate the regulatory controls abroad.[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.

While patient confidentiality surrounding the use of medical devices is extremely important, in some instances, a patient’s healthcare provider may release personal medical information to a medical device company without prior written consent from the patient. This applies if the medical device is deemed necessary for medical care, as part of the patient’s overall treatment plan.

Emerging Regulatory Controls—Cybersecurity Threat

One of the trending issues surrounding medical device manufacturing concerns the approval process and the fact that it does not always include a series of intense clinical trials. Through pre-market submission and post-market surveillance, the United States and the European Union handle overall product safety. Non-clinical safety issues still exist however, with networked medical devices. The FDA has now proposed regulatory action to help protect against cyber attacks and the ever-increasing threat to medical devices. Hackers have the ability to tap into pumps, pacemakers, heart monitors, and much more. By interrupting or intercepting information between a medical device and server, hackers can take control and change the way in which a medical device operates, causing potential harm to the end user.[7]

As medical device technology continues to rapidly expand, the need for greater regulatory oversight will most certainly be necessary moving forward.

References

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.