While work on Capitol Hill has seemingly ground to a halt as Congressional Democrats and Republicans sharpen their arrows for their epic battle this November, work at the U.S. Food and Drug Administration continues to move full steam ahead (well, as full steam ahead as one can expect from the federal bureaucracy). In August, the FDA released a report outlining recommendations for potentially significant changes to its process for clearing certain medical devices to market. Separately, that same month, the agency announced it is seeking input on ways to update and improve its eight-year-old medical device user fee program. Given that nonwovens are utilized in a range of products classified as medical devices, this article will review these FDA activities.
510 (K) Reform
For those who aren't familiar, FDA maintains a three-tiered regulatory system with safety and effectiveness requirements applicable to all medical devices, and a separate scheme that places them into one of three groups: classes I, II, or III. Class I devices are those regarded as low-risk (e.g. tongue depressors, etc.) and are thus generally exempt from agency premarket review, while class III describes those deemed highest-risk (e.g. replacement heart valves, pacemakers, etc.), requiring a thorough scientific and regulatory review known as Premarket Approval (PMA) to gain distribution approval. Medium-risk devices (class II), including nonwoven tampons, surgical drapes, gowns and masks, are generally subject to Premarket Notification or 510(K) requirements, meaning they may not be commercially distributed until the manufacturer has demonstrated the device is "substantially equivalent" to an already established legally marketed device or "predicate."
Although the framework has been in place for more than 30 years, the 510(k) program has recently come under scrutiny following embarrassing and very public revelations that FDA failed to use established procedures when it granted clearance to ReGen Biologic's Menaflex knee implant in 2008. FDA's experience with Menaflex, as well as the findings of an early 2009 Government Accountability Office report, prompted the agency in September 2009 to convene a Working Group to evaluate possible 510(K) improvements.
After months of internal study and stakeholder feedback, the Working Group August 4 released its preliminary report, a 120-page document that proposes a number of key recommendations intended to improve safety, efficiency and foster device innovation. For example, in order to better support new device development, it calls for streamlining and clarifying manufacturer expectations for the so-called De Novo process of approving novel devices that cannot be cleared through 510(k) but are not sufficiently high-risk to warrant a more demanding PMA review reserved for class III devices.
In order to clarify documentation requirements for 510(k) submissions and avoid time-consuming follow-up requests for information, the Working Group also proposes to split class II devices into two subsets, IIa and IIb, with class IIb devices requiring additional clinical data and manufacturing information to be cleared for market. The group also calls upon the agency to develop guidance that clarifies when a device should not be used as a predicate, such as when it has been removed from market due to safety concerns. It also advocates new regulations that clearly establish when and how the agency may rescind a 510(k) clearance and its use as a predicate.
Industry reaction has been mixed, with medical device groups praising suggestions like the De Novo and split class proposals, which they say will enhance clarity and consistency in the review process. At the same time, however, they have voiced reservations about the sheer number of recommendations and related costs described in the report. "There are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years," AdvaMed president Stephen Ubl said August 4.
Meanwhile, certain proposals, including one to have FDA seek expanded authority to consider off-label use when performing 510(k) reviews, could have unintended consequences, they argue, for example, requiring companies to provide data for device uses they never intended.
The agency, which is accepting public input on the report until October 4, is quick to stress that the report's findings are preliminary." We will make a decision on which recommendations to adopt only after a thorough review of additional comments," Center for Devices and Radiological Health Director Jeffrey Shuren said August 4.
To view the 510(k) Working Group's preliminary report, visit: www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf. To learn how to submit comments, visit: http://www.gpo.gov/fdsys/pkg/FR-2010-08-05/pdf/2010-19339.pdf.
Medical Device User Fee Reauthorization
The FDA announced August 13 it is now soliciting public input on its medical device user fee program, which is set to expire in September 2012. The program, which was created by the Medical Device User Fee and Modernization Act of 2002 allows the agency to collect user fees from device companies in order to address funding shortfalls and make the device review program more effective and efficient. The 2007 reauthorizing legislation, the Medical Device and User Fee Amendments, made several key changes, among them, lowering the amounts companies must pay for device reviews. At the same time, however, it imposed four new fee categories as well as yearly increases beginning in FY 2008.
Some are quick to point out that the FDA has, in fact, increased fees every year since the program's inception and is now collecting almost three times as much as it took in during its first year. Meanwhile, the new schedule for FY 2011 announced in April, which goes into effect on October 1, instituted across-the-board hikes of 8.5%. Many question whether the money is being well-spent, pointing out that the number of review cycles per 510(k) submission and the time spent responding to FDA requests for additional data have increased significantly in recent years.
FDA is accepting stakeholder comments on these and other issues until October 14. To learn how to weigh-in on the medical device user fee program, visit: http://www.gpo.gov/fdsys/pkg/FR-2010-08-13/pdf/2010-19843.pdf.
What's Next?
The second prong of the FDA's 510(k) assessment is an Institute of Medicine report slated for completion in mid-2011. It is expected to recommend legislative changes to bolster the FDA's oversight of medical devices. The IOM input along with that of the Working Group will likely play a significant role in the debate surrounding the user fee reauthorization during the next session of Congress.
In the meantime, once the Working Group's analysis is complete, FDA is expected to announce final decisions on revisions--through guidance or regulation--with projected timelines. As always, INDA will keep its members informed of any related developments as they unfold.
By Jessica Franken
INDA, Association of the Nonwoven Fabrics Industry
Source Citation
Franken, Jessica. "FDA hard at work on medical device initiatives: agency also looking to update eight-year-old medical device user fee program." Nonwovens Industry Oct. 2010: 22+. General OneFile. Web. 20 Oct. 2010.
Document URL
http://find.galegroup.com/gps/infomark.do?&contentSet=IAC-Documents&type=retrieve&tabID=T003&prodId=IPS&docId=A239480782&source=gale&srcprod=ITOF&userGroupName=18551_mcpls&version=1.0
Gale Document Number:A239480782
Disclaimer:This information is not a tool for self-diagnosis or a substitute for professional care.
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