Therapeutic practices based on medical equipment are becoming increasingly important, with new markets worldwide and technological advances in disease management for various illnesses. On the other hand, such treatments may also be associated with predictable and unanticipated dangers that can result in abrupt, life-threatening consequences in some situations.

Regulators must balance the benefits of potential therapy choices against their risks when determining whether a new product should be authorized. The monitoring of device risk-benefit information continues beyond the point of regulatory decision-making into the post-approval period. Various methods have been created to evaluate device performance post-approval.

Regulatory Authority

Since the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) were passed in 1976, the FDA has been tasked with assuring the safety and efficacy of new medical devices. This law set forth that only FDA approval would be required for device manufacturers to market medical devices in the United States for use in patient care. The subsequent legislation introduced user fees, and the government’s evaluation periods were extended. The 2012 FDA Safety and Innovation Act (FDASIA) maintained the existing structure of device evaluation, including user fees and performance goals through 2017.

Pre-Market Evaluation

medical device safety standardsThe US Food and Drug Administration (FDA) uses a risk classification system to regulate device approval. All proposed new medical devices are assigned to one of three risk categories, which are Low-risk (Class I), Moderate-risk (Class II), or High-risk (Class III). The FDA evaluates Class I devices only after they have been approved. Most Class I devices are not subject to a formal premarket review process. Medium-level (Class II and complex Class I) devices must satisfy additional specialized requirements, such as biocompatibility testing or environmental interactions.

The FDA uses the “510(k) process,” after the section of the FDCA that describes it, to assess most medium-risk goods. A finding of substantial equivalence certifies that a device is comparable to a previously-approved device, such that it raises no new safety or effectiveness issues. Manufacturers have demonstrated substantial equivalence for over 90% of medium-risk devices without additional clinical data.

Adverse Event Reporting

The FDA has established reporting requirements for adverse events. User facilities must notify the FDA and manufacturer of device-related deaths or severe injuries within ten business days. Manufacturers and importers must announce to the FDA any problems discovered by their users or staff within 30 days or five days if the adverse event “requires remedial action to prevent an unreasonable risk of substantial harm to the public health.” Patient demographic data, clinical information on the underlying medical issues, and device and procedure specifics are included in these reports.

In 1993, the MedWatch initiative established a more user-friendly adverse event reporting process for patients. MedWatch gathers voluntary reports from health care providers and patients and necessary documents from user facilities, importers, and manufacturers. Reports may be submitted by phone, fax, mail, or electronically, including by mobile applications currently being tested. The reports are evaluated by FDA staff, which can result in additional investigations or public safety warnings.

Quality Systems Regulation

medical device safety alertManufacturers must adhere to logistical criteria established by the Quality System Regulation (QSR) for “the methods used in, and facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” QSAR includes recording, auditing, and monitoring design, production, storage, and distribution activities, generally focusing on on-site inspections. QSR depends on the device’s risk category; therefore, Class II and III devices are subjected to more rigorous testing and monitoring than lower-risk gadgets.

To obtain certification for QSR, producers must show a method for addressing identified concerns, known as Corrective and Preventive Action (CAPA). CAPA specifies that “Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems” must be included in the organization’s analytical methods. The FDA requires CAPA programs to conduct investigations, collect data, and propose solutions that range from production or labeling modifications to recall announcements.

Emerging Strategies

The FDA has introduced a preliminary national strategy, which includes a device identifier (UDI) system, to better track devices after they have been approved. UDIs may assist particular trace devices utilized or implanted in individual patients and thus allow the connection of gadgets to clinical information that may help contextualize adverse event reports.

Mr. Edward James is a medical device innovator with over thirty years of experience in the field. He has developed products that have saved lives and improved patient care worldwide. In this blog post, we’ve discussed some of the challenges faced by those in the medical device industry when it comes to assuring product effectiveness and safety. Visit our website today for more information.

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