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Translational Medicine FDASIA Continued from page 59 More PCR control at your fi ngertips IVD firms in the past tended to submit few investigational device exemptions (IDEs). With the growth of companion diagnostics, the number has increased. FDASIA limits the grounds for denying an IDE. Rob Byron/Fotolia tended use of the device." FDA's report must provide FDA's interpretation of these phrases. FDASIA requires FDA to consider the input of "interested stakeholders" when de- veloping the report. FDA may not issue any draft guidance or proposed regulation until Congress receives the report, and may not is- sue any final guidance or regulation until at least one year later. Given the importance of this issue, it is one that IVD 510(k) holders will want to monitor carefully. FDA had issued a proposed draft guid- ance on July 27, 2011. This draft provoked widespread opposition. FDASIA states that FDA may not use the draft "as part of, or the basis of, any premarket review or any compliance or enforcement decisions or ac- tions," and that the old 1997 guidance on device modifications remains in effect. IVD companies should be alert to FDA staff try- ing to apply the rejected draft guidance. De Novo Application Process The 510(k) process is generally the pre- ferred route for IVD companies. However, to obtain 510(k) clearance requires dem- onstrating "substantial equivalence" to a "predicate device." For newer IVDs, there may not be a clear predicate device. The de novo process provides a solution, essentially allowing low and moderate risk devices to go through the 510(k) process despite the lack of a predicate. FDASIA tries to improve the de novo process. Previously, a sponsor had to sub- mit a 510(k) notification to FDA and re- ceive a "not substantially equivalent" letter before submitting a de novo petition, even if the sponsor and FDA knew no appropri- ate predicate device existed. Moreover, there was no way to definitively find out in ad- vance whether FDA would agree the product was eligible for de novo review. FDASIA allows a sponsor to ask FDA if an IVD can go through the de novo process without first submitting a 510(k). FDA can agree that the de novo route is appropriate. Alternatively, FDA could identify a predicate device that the company could use. This ac- tion would mean there is no need for the de novo process because a traditional 510(k) can be used instead. On the other hand, CDRH can decide that there is no predicate and the product is not eligible for de novo review if it finds that the device is not "low-moderate" risk or that general controls would be inadequate to control risks and special controls cannot be developed. Unless overturned, this decision means a PMA will be necessary. This provision could have a significant positive effect. It creates a vehicle for IVD companies to learn early on whether the de novo pathway is open, a 510(k) can be submitted, or a PMA will be required. Many novel IVD products lack clear-cut predicate devices. Unfortunately, because Congress gave FDA 120 days to respond to the request, the process may not provide speedy answers for sponsors. Even so, gaining that information early in the process could be helpful. More- over, Congress' actions may encourage FDA to use the de novo process more. FDASIA contains other provisions that may be relevant, such as expanding the Hu- manitarian Device Exemption Program for products for rare diseases, modifying FDA's device recall program, and reinforcing the im- portance of the "least burdensome" standard. In addition, FDA has committed to new user fee goals, which should result in faster decision making. One direct effect is FDA's issuance of a Refuse to Accept draft policy for 510(k)s. Companies submitting 510(k)s should carefully examine this checklist be- fore sending their notification to FDA. FDASIA does not revolutionize FDA reg- ulation of IVDs. However, some of the pro- visions may offer significant benefits to IVD companies. Companies therefore should evaluate what impact the law may have on their regulatory situation and how to use the law to their advantage. Veriti® Thermal Cycler System The best choice for most applications "Better-than-gradient" control, color touch screen, and easy networking. 2720 Thermal Cycler Economical option for everyday cycling Personal sized for effi cient, non-gradient cycling. GeneAmp® 9700 PCR System The best choice for high- throughput applications Interchangeable blocks, with dual 96-well and dual 384-well block formats. Shop now at lifetechnologies.com/selectcycler For research use only. Not for use in diagnostic procedures. ©2012 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. CO26354 0912 genengnews.com | October 1, 2012 | 61Genetic Engineering & Biotechnology News | genengnews.com | October 1, 2012 | 61