Everything You Need to Know About Medical Device Compliance

Fundamentals of Medical Device Regulations

FDA medical device regulations govern the manufacturing of medical devices. Medical device FDA regulation requires manufacturers to comply with all necessary principles before they are approved for sale.

According to FDA medical device regulations, Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term “device” refers to:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is –

(a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(c) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

Medical device FDA regulation stipulates that no medical device shall be adulterated or misbranded. Violations of these two requirements will result in a letter to the device manufacturing company issued by the Office of Compliance.

Medical device manufacturers must list their medical devices through electronic establishment registration when they plan to bring the device to market.

Device manufacturers, importers, and user facilities must report via the Medical Device Reporting program any time there is an adverse event related to use of a medical device. Care must be exercised when sharing sensitive information; it should be encrypted and transmitted securely, especially when protected health information is enclosed.

Such mandatory reporting is important because it allows the FDA to track problematic and potentially dangerous devices, and to protect the public.

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Medical Device Classifications

The FDA classifies medical devices in three classes:

Class I: Basic devices that are associated with low level of risk, such as a reflex hammer or bandage.

Class II: Devices with moderate risk whose malfunction have a low risk of causing immediate death or harm to the patient, such as a diagnostic specimen kit.

Class III: Devices associated with a high amount of risk. In some cases, failure with these devices could result in immediate death or harm to the patient, such as a pacemaker. It is important, note, however, that this is mostly risk-based.

FDA medical device regulation requirements increase through the classes, along with testing standards. Most of the Class I medical devices are exempt from Premarket Notification 510(k), whereas most Class II devices are non-exempt.

The Code of Federal Regulations states whether a medical device is required to have a 510(k) or if the device is exempt, so there is no need to guess. Due to the high-risks associated with Class III devices, most require Premarket Approval.

Special controls may be required for Class II medical devices. This could be as simple as special labeling requirements. Be sure to check if your device requires special labeling or other specific controls.

A 510(k) will be required anytime a medical device manufacturer plans to market a device for the first time or has made major adjustments to an existing device. It is important to note, there is a 510(k) device user fee.

Class III medical devices must go through a Pre-Market Approval Program (PMA). This involves completing a thorough application submission for high-risk medical devices.

Again, whether a PMA is required can be identified through the Code of Federal Regulations. The PMA could be required if a medical device is not substantially equivalent to any other device on the market.

According to the FDA, a medical device is considered to have substantial equivalence if it has the same intended use and technological characteristics as the predicate device.






A Reliable Partner That Places Compliance First

With more than 25 years of experience developing medical devices, we understand the importance of providing predictable results to our clients throughout our development process.

At RBC Medical, we ensure the right people work on the right projects to exceed our clients’ expectations and get their products to market faster.

If you are looking to partner with an industry leader in developing medical devices that adhere to FDA and all other major regulations, contact us today.


medical device regulation complianceThe medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and follow quality systems that ensure products consistently meet applicable requirements and specifications, the FDA offers little guidance to the medical device industry as to how. This leads to confusion and, ultimately, non-compliance for many. Today, we will examine the most common FDA medical device f regulatory compliance pitfalls that companies encounter—so you know what to avoid as you bring your next product to market in the US.

Four medical device regulatory compliance pitfalls—and how to avoid them:

1.      CAPA violations: Corrective and Preventative Actions (CAPA) procedures and systems aredesigned to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. While CAPA’s are not optional,many companies are being cited for CAPA violations—typically for inadequately establishing CAPA procedures or failing to document them. Don’t wing it when it comes to CAPA. Establish your procedures early as part of an overall Quality Management System—and make it front and center. When conducting a CAPA investigation, be thorough so that you can get at the root cause of a problem.

2.      Inadequate complaint procedures: As outlined in the FDA’s Code of Federal Regulations Title 21, medical device manufacturers are required to follow a specific procedure for customer complaints. Any complaint that alleges fault with your device, whether written or verbal, must be clearly documented and addressed. Without an adequate complaint-handling system, you not only run the risk of non-compliance but also open your company up to recalls and product seizures. To avoid this, establish and implement complaint procedures that define how you will receive, evaluate and address complaints.

3.      Poor document management and control: ISO, ISO 13485, and 21 CFR Part 820 9001 contains specific requirements around the control of your documents to prove conformity and demonstrate the effective operation of your quality management system. However, they don’ttell you which documents require those controls, how they should be formatted and labeled or how many approvals are needed. As a result, many medical device manufacturers find themselves unexpectedly failing an audit. Consider using a browser-based software program, like Polarion, to easily track and manage your documentation throughout the lifecycle of the project.

4.     Medical device reporting: Manufacturers are required to report any medical device incidents that cause serious injury or death—or a malfunction that could lead to serious injury or death. Those who fail to create and follow written medical device reporting procedures are in violation of 21 CFR 803.17.  Keep in mind, omitting certain terms defined in 803.17, or even key descriptions, may also render you non-compliant. Beyond establishing formalized written procedures and plans per the FDA requirements, be sure to abide by and frequently review them to ensure they continue to meet the code.

With so much to keep track of when it comes to FDA medical device regulation compliance, it’s no wonder so many manufacturers find themselves in trouble. Ultimately, achieving and maintaining medical device regulatory compliance comes down to a commitment to quality. With quality as the guidepost, you can avoid most of these headaches, save money and get your product to market faster.

At Sterling Medical Devices, we offer regulatory compliance consulting to help you meet regulatory controls throughout the entire product development life cycle. To talk to someone today about your medical device regulatory compliance concerns or for more information about our FDA medical device regulatory compliance consulting services, contact us here

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