Medical Device Regulations

KEY POINTS

The Medical Device Amendments (MDA) of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA) extended the FDA’s regulatory authority to medical devices and created a comprehensive “regime of detailed federal oversight.”¹
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their intended use, indications for use, and risk. Class III devices pose the highest risk, are strictly regulated and require FDA approval before they may be sold in the US.
To market a Class II or Class III medical device, manufacturers must obtain FDA approval for a Class III medical device through FDA’s premarket approval (PMA) process or FDA clearance for a Class II device through the 510(k) review process.
The FDA’s regulatory role does not end with approval of the initial PMA application or clearance of the 510(k), but includes continued oversight of manufacturers, including over their obligations to continue to monitor products and report adverse events pursuant to regulations.
Medtronic is not only committed to following the FDA’s regulations, but also the laws and regulations of other countries where our products are sold.
As stated in our Mission, Medtronic is committed to delivering products and solutions at prices that are fair and reasonable, and to making healthcare accessible and sustainable.

The Medical Device Amendments

The Medical Device Amendments (MDA) of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA) extended the FDA’s regulatory authority to medical devices and created a comprehensive “regime of detailed federal oversight.”² In enacting the MDA, Congress sought to ensure that safe and effective medical devices would be readily available to treat patients in need of lifesaving care. To that end, Congress crafted a regulatory framework striking a careful balance between regulation and innovation. The MDA “provide[s] for the safety and effectiveness of medical device[s],” while simultaneously “encourag[ing] the[] research and development” of “sophisticated, critically important” devices.³

Medical Devices Classifications

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their intended use, indications for use, and risk. Class I devices (for example, tongue depressors) generally pose the lowest risk to the patient and/or user. Class II devices (for example, hearing aids) are generally reviewed through the 510(k) review process and require FDA clearance before they may be sold in the U.S. The 510(k) process is designed to assess the safety and effectiveness of low- and moderate-risk medical devices where the risks are well understood and well characterized based on experience with similar devices. The 510(k) review process is based on a comparative review that requires that the manufacturer demonstrate that the new device is “substantially equivalent” to a legally marketed device. In addition, Class II devices must comply with performance regulations known as “special controls.” The 510(k) review process differs from the review process for Class III devices, but safety and effectiveness considerations underlie both review processes. Class III devices pose the highest risk, are strictly regulated and require FDA approval, as described below, before they may be sold in the U.S.

The FDA’s Premarket Approval (PMA) Process for Class III Devices

To obtain FDA approval for a Class III device, a manufacturer must submit a detailed premarket approval (PMA) application that contains full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in the manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information.

The FDA closely scrutinizes PMA applications, weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. The agency “spends an average of 1,200 hours reviewing each application” and “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.”’⁴ The Agency can demand the manufacturer provide more information, refer the application to a panel of outside experts, or impose additional requirements.

The FDA’s Continued Monitoring and Adverse Event Reporting Requirements

The FDA’s regulatory role does not end with approval of the initial PMA application. Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. If a manufacturer wishes to make such changes, it must submit a PMA supplement and may implement the proposed changes only after FDA approval.

The FDA’s Medical Device Reporting (MDR) regulations contain mandatory requirements to report certain device-related adverse events and problems to the FDA. Specifically, manufacturers must inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred.

Medtronic’s Commitment to Follow FDA and Other Countries’ Regulations

Medtronic is not only committed to following the FDA’s regulations, but also the laws and regulations of other countries where our products are sold. We take these obligations seriously, as reflected in our Code of Conduct, which states: “No matter where we conduct our individual work, following the laws, regulations, and Company policies in the countries where we do business is not only required, but also critical to our success. Global laws and regulations are complex, subject to change, and often vary from country to country. This is why each of us must learn and follow the laws, regulations, and Company policies that apply to our individual work, and seek guidance whenever we have questions. Each of us must be cooperative and truthful in connection with any investigation conducted by or for the Company into possible violations of the law, regulations, or company policies. Any failure to do so will be grounds for discipline, up to and including termination.”

Medtronic’s Commitment to Fair Pricing

As stated in our Mission, Medtronic is committed to delivering products and solutions at prices that are fair and reasonable, and to making healthcare accessible and sustainable. We continue to be a leading advocate for Value-Based Healthcare (VBHC), working with the global healthcare community to create innovative new products and service offerings with better outcomes for patients in relation to the costs. Medtronic also supports an open and competitive market dynamic. To that end, pricing is determined through the value provided to our customers, whether measured by financial, clinical or patient-reported outcomes, but is also subject to a variety of unique healthcare system structures and the dynamics of a competitive marketplace. There are a number of considerations that determine product prices across the world, most importantly healthcare system structures, tendering and procurement laws, competitive dynamics, the amount and nature of services associated with the actual product delivery, specific patient needs and customer purchase volumes.