Increased FDA scrutiny of medical devices
May/07/09 07:51 Filed in: Medical devices | Medical products
In the early 1990’s, Congress directed the US Food and Drug Administration (FDA) to gather more rigorous evidence before a they give approval to manufacturer to market medical devices that were considered the most risky, a category known as Class III devices. The FDA never implemented the law, and several hundred Class III devices were approved by the FDA based on a less rigorous path using a 510(k), which allows the manufacturer to establish that their products are “substantially equivalent” to products marketed before 1976. Early this year, the Government Accounting Office (GAO) issued a report that stated these conclusions about the process:
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices.
On April 9 2009, the issued an order entitled: “Required submission of safety and effectiveness information for certain Class III devices.” It requires manufacturers of twenty five Class III devices to resubmit an application to the FDA to determine if the product should be reclassified or if the manufacturer will be required to gain approval through the PMA process.
The most products covered in this order are automatic external heart defibrillators, dialysis catheters, hip joints, spinal screws, a heart pump and several others from several large companies, including Medtronic (NYSE: MDT), Phillips, Zoll (Nasdaq: ZOLL), Covidien (NYSE:COV), Zimmer (NYSE: ZMH), Johnson & Johnson (NYSE:JNJ), and Abiomed (Nasdaq: ABMD) are covered by this order. It will take several years to go through this process, and the FDA has given a grace period for the manufacturers to go through the process.
The consequences of this regulatory action are that many of these products, which were approved through the 510(k) process available at the time, will have to go through the full PMA process, which is time consuming and puts somewhat more controls on the marketing of the product. I also wonder if some of the products will be soon replaced by “new and improved” offerings from the company, and those manufacturers may not pursue a new submission.
Going forward, it’s clear that manufacturers will have to gain FDA clearance for Class III devices through the PMA process, and that’s a good thing for medical products consumers. Device companies may grumble a bit, but then move on, as they usually do.
By Michael W Simpson
FDA has stated that eventually all class III devices will require FDA approval through the PMA process and FDA officials reported that the agency is committed to addressing this issue, but the agency has not specified time frames for doing so. Without FDA action, the remaining preamendment class III device types—including device types that FDA identified in 1994 as presenting an unreasonably high risk to public health—may enter the U.S. market through FDA’s less stringent premarket notification process.
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices.
On April 9 2009, the issued an order entitled: “Required submission of safety and effectiveness information for certain Class III devices.” It requires manufacturers of twenty five Class III devices to resubmit an application to the FDA to determine if the product should be reclassified or if the manufacturer will be required to gain approval through the PMA process.
The most products covered in this order are automatic external heart defibrillators, dialysis catheters, hip joints, spinal screws, a heart pump and several others from several large companies, including Medtronic (NYSE: MDT), Phillips, Zoll (Nasdaq: ZOLL), Covidien (NYSE:COV), Zimmer (NYSE: ZMH), Johnson & Johnson (NYSE:JNJ), and Abiomed (Nasdaq: ABMD) are covered by this order. It will take several years to go through this process, and the FDA has given a grace period for the manufacturers to go through the process.
The consequences of this regulatory action are that many of these products, which were approved through the 510(k) process available at the time, will have to go through the full PMA process, which is time consuming and puts somewhat more controls on the marketing of the product. I also wonder if some of the products will be soon replaced by “new and improved” offerings from the company, and those manufacturers may not pursue a new submission.
Going forward, it’s clear that manufacturers will have to gain FDA clearance for Class III devices through the PMA process, and that’s a good thing for medical products consumers. Device companies may grumble a bit, but then move on, as they usually do.
By Michael W Simpson