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Author: Bruce Swope | Date: November 12, 2012
Designing, developing and bringing to market a new medical device is a complex process. Here are some of the things you need to know about the medical device FDA approval process:
Medical devices are covered by FDA regulations in the US and by Medical Device Directives in European Union (EU) countries. Technically, the FDA does not “approve” Class 1 and 2 and some Class 3 medical devices for sale in the US. Instead, they give “clearance” for them to be sold.
The two major processes by which medical devices requires FDA review are:
In order to be eligible for 510(k) clearance, a new device must exhibit roughly the same safety and effectiveness characteristics as a “predicate” device to which the new one is being compared. The PMA process, on the other hand, is based on a demonstration of safety and effectiveness through “adequate and well-controlled” clinical trials. A successful PMA submission results in approval of the new device. An excellent discussion of the differences between 510(k) and PMA can be found at www.devicewatch.org/reg/510k.shtml.
While the FDA requires evidence of both safety and efficacy of a device, a European CE Mark requires only proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. As a result, FDA Clearance can require as long as 3 years while CEO Marking can usually be obtained in a much shorter time., leading to considerable discussion regarding which path should be sought first. An excellent discussion of this topic can be found at www.mdtmag.com/articles/2012/02/which-way-go-ce-mark-or-fda-approval.
Obtaining FDA clearance can be a long and arduous process. It often involves many subjective decisions regarding safety and efficacy. As a result, it is strongly recommended that you engage the services of a reputable submission consultant to help develop a strategy at an early stage. A list of submission consultants can be found simply by typing “FDA Submission Consultants” into the Google search engine.
Throughout the process, it is very important to maintain open communication, getting the FDA involved as early as possible and understanding where your device fits and what they are looking for. It is also important not to overcomplicate the documentation, but rather to stick to the facts and keep it as simple and straightforward as possible. The submission consultant you select can provide valuable assistance with this.
Discover more insights about the medical device FDA process in our informative white paper, “The Common Pitfalls of the Medical Device FDA Submission Process.”
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