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Due to their different nature, medical device regulations differ from pharmaceutical regulations in terms of governance and development timeline. They are treated more like engineering products with shorter development cycles.
IDE
As medical devices range from something as basic as dental floss to complex artificial organs, federal regulations governing these devices can be quite complex. To make things simpler, the Food and Drug Administration offers very helpful guidance documents as well as an easily navigable website providing clear access to understandable information – medical device manufacturers and clinical investigators should take full advantage of these resources.
Research studies of medical devices fall under medical device regulatory authority, and researchers at academic health centers conducting such trials must abide by 21 CFR 812’s Investigational Device Evaluation regulation (IDE regulation). The FDA has tailored its responsibilities regarding their conduct to match study subjects to devices being studied – this regulation distinguishes between significant-risk (SR) device studies that must be approved by both IRBs and the FDA, and non-significant-risk device trials which may proceed with reduced requirements; studies involving significant-risk devices require approval by both bodies whereas studies may proceed with reduced requirements or requirements being waived altogether.
Manufacturers of new medical devices must become acquainted with the FDA IDE manual and make efforts to expedite review times for their IDE applications, in order to foster innovation, safety, transparency, and accountability that ultimately benefits both industry participants and healthcare providers alike.
QS
While this regulation retains FDA good manufacturing practice (cGMP) requirements, it also incorporates ISO 13485:2016’s medical device quality management system standard as requirements set out within it.
Under the new regulations, manufacturers are required to establish a quality system in order to ensure device safety and effectiveness. Regulatory inspectors evaluate manufacturing facilities, production processes, recordkeeping requirements, corrective action programs and corrective action programs as per ISO 13485 rules; while FDA’s cGMP rules provide general objectives.
Manufacturers that previously followed cGMPs may find adapting to ISO 13485 an immense challenge, including updating internal procedures, altering IT systems, and training staff on its requirements. Furthermore, QMSR requires a quality system covering the entirety of product life cycle management while cGMPs focused more on design controls.
The new rule also requires manufacturers to demonstrate that their quality systems can produce high-quality devices through nonclinical testing and, where necessary, human clinical trials. These requirements aim to foster a culture of quality within the medical device industry while assuring compliance with FDCA and international standards.
Labeling
Labeling of medical devices provides vital information that ensures they are used appropriately, including symbols, instructions and warnings. Labeling is a central aspect of medical device regulation as it impacts both design and production as well as marketing and distribution channels for devices.
Manufacturers must establish an efficient process to create accurate labels for their products. Inaccurate labeling can result in serious consequences, including patient harm and product recalls; wrong labels could even prompt legal proceedings against manufacturers.
Manufacturers must also implement an efficient quality system to ensure their devices are safe for use, particularly medical device companies that need to work with multiple distributors and suppliers; medical device firms need a system in place that allows them to monitor distribution in real time as well as detect any quality issues quickly.
The EU Medical Device Regulation (MDR) establishes specific labeling requirements for device manufacturers. For instance, MDR mandates that medical devices clearly marked with symbols identifying their regulated contents are clearly marked – much like California Proposition 65 requires outer boxes containing carcinogenic substances to be marked accordingly – as well as clearly showing off contact details from their manufacturer on packaging.
Marketing
Contrary to drug regulations, medical device companies do not need to adhere to any specific set of marketing guidelines in order to market their products effectively. Instead, there are guiding principles which must be observed so as not to mislead HCPs or patients by misdirecting promotional and advertising materials in any way.
As with the FDA’s 510(k) marketing pathway, medical device regulations mandate that all devices be promoted with labeling that meets FDA approval at all times – this includes posters at scientific/medical conferences as well as advertisements in periodicals and on the internet. Furthermore, FDA regulators monitor a company’s website, public documents like news releases or filings regarding its medical devices in order to gain insight into how effectively the company communicates them to their target audiences.
The FDA is very vigilant when it comes to advertisers who make comparative efficacy, comparability or superiority claims in product advertising, often sending warning letters on this matter. Furthermore, Europe’s new Medical Device Regulation (MDR) mandates clear reporting and transparency regarding quality issues related to medical devices in Europe – replacing the previous Medical Device Directive directly across Europe with unique device ID requirements and creating an EU data bank to guarantee traceability of devices within Europe.