Every year, new devices get approved by the FDA. Recently, they welcomed new spinal cord stimulators, advanced catheters, heart clip implants, and a valve replacement system.
If you have a background in selling medical devices, you may have considered entering a venture around them.
While the medical technology industry is a lucrative market, it takes a lot of seriousness to succeed in this business. One of the things a start-up medical device company needs to pay attention to is the legal requirements.
Regulatory Authorities and Framework
FDA and its faction, the Center for Devices and Radiological Health, conduct rigorous scrutiny to make sure that medical devices pass all standards before they reach the consumer market.
To help achieve consumer safety, FDA medical device classes were created. Each should fall into one of the three categories that currently exist based on risk levels.
Class I Devices
Low-risk devices belong to the Class I devices. As they don’t pose great risk to their users, they are subject to lesser regulatory control. Some of these devices include bandages and handheld surgical instruments.
Those who want to tap the medical device market may begin working around Class I devices, as most of them are exempted from premarket notification 510(k) requirements. Still, they need to adhere to general controls, such as product labeling, record keeping, and GMP.
Class II Devices
Devices with moderate risk are categorized under Class II. They are subject to greater regulatory control compared to Class I items. Some products in Class II include surgical drapes, infusion pumps and wheelchairs.
This is where the FDA will require premarket notification 510(k) and premarket approval requirements. Here, manufacturers must demonstrate that their medical devices are equivalent to a legally marketed device. On top of general controls, Class II devices must also comply with additional special controls.
Class III Devices
Lastly, the high-risk products fall under the Class III category. These medical devices will go through the stricter form of regulatory control. Devices in this class may cause injury or death if they fail. Some of these are breast implants, heart valves, and pacemakers.
Class III devices require 510(k) and premarket approval (PMA). In addition to this, the manufacturer must demonstrate the device’s safety and efficiency with scientific evidence. The requirements for these products are far more comprehensive, with the required clinical trials and technical documentation involved.
Premarket Submission Requirements
Earlier, we mentioned 510k and PMA as requirements for medical devices. Every manufacturer should wrap their heads around their nuances to ensure compliance. Hence, we covered more details about these premarket submission requirements below.
510(k) Premarket Notification
The 510(k) is the most common premarket submission. To file this to the FDA, manufacturers must provide evidence that their device is equivalent to the device that’s already on the market. This must include information about the device’s design, intended use, performance testing, and comparison to the predicate device.
The FDA typically reviews 510(k) files within 90 days. This could be extended depending on the submission quality and complexity of the device. The agency must determine that the device is substantially equivalent to existing products before it can reach the U.S. market.
Premarket Approval (PMA)
For Class III devices, the PMA process is required. This is a more stringent and costly process compared to the 510(k) pathway. The PMA process requires manufacturers to submit extensive data, including results from clinical trials, to demonstrate the device’s safety and effectiveness. The FDA reviews the data in detail, and the process can take several months to over a year, depending on the complexity of the device and the completeness of the submission.
PMA is required for any device that represents a new category of technology, even if it is similar to an existing product. This process often involves an advisory panel of experts who review the data and provide recommendations to the FDA.
Quality System Regulations (QSR)
Regardless of the classification, all medical devices must comply with the FDA’s Quality System Regulations (QSR), which outline the requirements for the methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, and distribution of medical devices. The QSR is designed to ensure that medical devices consistently meet applicable requirements and specifications.
Key elements of QSR include:
- Design Controls
- Corrective and Preventive Actions (CAPA): Procedures for identifying, correcting, and preventing defects or problems.
- Document Controls
- Purchasing Controls
Failure to comply with QSR can result in enforcement actions from the FDA, including warning letters, fines, and even product recalls.
Labeling and Marketing Compliance
Labeling is a highly important aspect of medical device regulation. The FDA strictly requires that medical devices must be labeled with accurate information about the following:
- Device’s intended use
- Instructions for use
- Warnings
- Contraindications
The labeling must not be misleading in any way. Also, all promotional materials must be consistent with the approved labeling.
Additionally, marketing a device for any off-label use can lead to severe legal consequences, including fines and product seizures.
Postmarket Surveillance
The FDA continues to monitor the performance of products that made it to the market through postmarket surveillance activities. Manufacturers must report any adverse events, from malfunctions to patient injuries, through the FDA’s MDR system. Postmarket studies may also be required for additional data on the device as it encounters real-world settings.
