Tag Archives: FDA

What are the most common issues during FDA inspections of medical devices?

FDA inspections are par for the course in the medical device industry. Every medical device company class II or higher, in fact, should be inspected at least once every two years, according to existing bylaws.

Every medical device, medical device company and FDA inspection is different, but if you look at the applicable data from 2013 you can see some very clear trends in the most common features of these inspections.

FDA 483 Observational data for 2013 shows that more than 35 percent of the observations involved three areas: Design controls (13.25%), Corrective or Preventative Action (11.75%) and Complaint Handling (10.65%). These statistics are invaluable when it comes to focusing on your next FDA inspection.

To make sure your FDA inspections flow as smoothly as possible, ensure the protocols below are followed:

  • Properly document all design controls. Your lack of thoroughness will not go ignored.
  • Follow the proper corrective and preventive actions when responding to problems. It can be tempting to simply jump in and fix the problem, but moving forward with a controlled approach will pay dividends in the end.
  • Record all complaints. Operating with the “out of sight, out of mind” method can be tempting when dealing with complaints, but fixing the issue without following the proper investigative protocols will lead to future inspection questions.

FDA inspections are a common feature of the medical device industry and something companies should be prepared for every day. Adhering to strict guidelines throughout the year will lead to a smoother inspection process.

How medical device surveillance benefits clinicians

Patients deserve high-quality care options, thoroughly grounded in research to ensure the best possible outcomes. It sounds like an obvious staple of the health-care world, but this is not always the case.

Efforts exist to better understand the effects of prescription drugs – both benefits and risks – but no such efforts exist to discover the same in medical devices. In fact, many devices have little accompanying data pertaining to their effectiveness, reliability or quality once they are released to the market. Instead, these things are learned “in the field” when they are used in association with the treatment of patients. Rarely is that information shared.

This isn’t to say clinical trials are not done – far from it in fact. But the information these trials offer often fails to answer the questions that arise from in-practice situations.

Medical professionals are working to change this. A joint project from the Center for Health Policy at Brookings, the Food and Drug Administration and clinician, industry, payer and patient representatives will seek to outline the process for creating a national system that captures important device-related information as they are used in the field.

The medical device post market surveillance system, as it is being called, aims to improve safety surveillance while supporting device evaluation capabilities. The data gleaned here will further allow clinicians to analyze the device’s capabilities, overall quality and how it compares to other devices in the same space.

To succeed, however, the system will need to determine how to gather this information while minimizing the reporting required from clinicians. Research shows the average clinician may spend as little as four minutes with a patient, and most spend 8-15 minutes reporting afterward. It is not possible for these numbers to actually decrease if additional reporting time is required.

This new evidence must also be delivered in real time in order to offer any benefit. In a fast-paced industry such as health care, data that is reported late will likely be reported for a device that has already become obsolete.

While these are important challenges, the idea of a medical device post market surveillance system offers benefits to everyone involved in health care. Patients deserve high-quality options and such a system makes those options possible.

To find the medical devices your health-care facility needs, visit MedicalDeviceDepot.com.

How patient experience improves the medical device industry

This is an exciting time to work in the medical device industry. After decades of trying to determine the role of patient experience when creating regulatory policy, it appears answers may finally be coming.

The Medical Device Innovation Consortium released what it calls an “initial thought piece” in May, providing a guide for device makers seeking out information regarding patient preference when submitting data to obtain product approvals. The Consortium represents a joint effort of the device industry itself, the National Institute of Health and the Food and Drug Administration.

Ross Jaffe of Versant Ventures says that while patient preference is not required for a device manufacturer to obtain FDA approval, device manufacturers should consider it “an enhancement of a submission.”

In addition, device manufacturers benefit from the newly released FDA guidance that outlines just what patient preference information will be reviewed and considered by the FDA when weighing approval of any application for a new medical device.

For medical device manufacturers, these developments shed new light on an area that has always been frustratingly unclear. Device manufacturers can now use this information and these new guidelines to efficiently deliver proper applications to the FDA and get new, helpful medical devices on the market for the health-care facilities and patients in need, all more quickly than ever before.

To find all of the medical devices your health-care facility needs, contact Medical Device Depot today

The steps to FDA approval for a medical device

Medical devices play a huge role in the health-care industry. They are there to resuscitate patients, monitor vital signs, diagnose disease and give medical support when needed. Because they are responsible for maintaining, preserving and improving the lives of patients, it is vital that these medical devices perform properly. The U.S. Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective for use. It is no surprise that such a large government agency with such an important job has a strict set of rules and guidelines to follow when it comes to approving effective devices for medical use.

When working to approve a new medical device, many steps need to be followed precisely. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating the firms that manufacture, repackage, re-label and import medical devices that are sold in the United States. The device requirements follow a rigid set of guidelines in order to ensure quality and safety. While the class of a device will determine how strenuous the process is, gaining the FDA’s approval is not an easy task at any level. Be extra cautious when purchasing medical equipment from China that is not FDA Approved. Items that are sold on eBay and other websites could cause more trouble than the bargain is worth.

According to the FDA’s Device Regulation and Guidance Overview, the basic regulatory requirements for manufacturers of medical devices include:

  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 510(k) or Premarket Approval (PMA)
  • When FDA review is needed prior to marketing a medical device, the FDA will either:
    1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA or,
    2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) regulation
  • Labeling requirements
  • Medical Device Reporting (MDR)

Once a device has the approval of the FDA, then they can move forward with putting the device into practice. Medical Device Depot only sells FDA Approved medical equipment, so you can rest assured that you will have the best quality when your browse our selection of devices.

How do apps affect the medical device industry?

There’s an app for everything these days, so it should come as no surprise that there are health-related apps as well – a lot of them. In fact, as far back as 2013 there were already more than 43,000 medical apps; researchers prognosticate that the health app market will reach $58.8 billion by 2020.

But is the health app explosion a good thing for the medical device industry and the general population?

It depends, namely on the information or services each individual app is providing. Apps have the potential to be helpful to the medical device industry by partnering with current devices to transmit data more efficiently, as well as provide supplemental information about a patient that the person may not know or be able to convey themselves. However, apps that provide their users with poor information can have a negative influence on the user’s health and health choices.

As the mobile health industry has evolved, the FDA has kept pace, treating health apps as it would any other medical device. “The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health-care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps,” it said in a statement. The FDA already works to determine which apps classify as medical devices and which do not merit FDA registration.

Effective health apps have the potential to be an important partner to the medical device industry, and that benefit figures only to grow as apps develop and the medical device industry itself works to create the apps it needs. But no matter the new tech, there will always be a place for apps that share accurate information in a safe, effective and healthy manner.

New medical device for migraine prevention

Thanks to increased research and improved medical devices, those who suffer from migraines may be able to find relief finally. The US Food and Drug Administration (FDA) has approved the first medical device to help prevent migraines from occurring. The crown-like device is placed just above a patient’s eyes and works by stimulating nerves beneath the forehead with an electric current. It simply feels like a gentle tingling sensation and is completely comfortable for the person wearing the device.

The new and exciting device is called the Cefaly, manufactured by STX-Med. It has no known side effect as of yet and can be used in conjunction with other medication. The device is already being sold in Canada for about $250, where migraine sufferers can purchase the device for home use.

While it is still a new device, the FDA approval and warm reception show great promise. A 67-person trial published in the journal Neurology last month found that Cefaly reduced chronic migraine attacks on average by two per month, and 38 percent of users had at least a 50 percent reduction in their number of migraines.

This new medical device could be a great addition to the world of medicine. Migraines have long been an issue for many people and any relief would be more than welcome.