FDA update  August 15th, 2011

Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years

The FDA welcomes comments on the following recommendations provided in

the IOM report:

1. The Food and Drug Administration should obtain adequate information to inform the design of a new medical device regulatory framework for class II devices so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the
2. device life cycle. Once adequate information is available to design an appropriate medical device regulatory framework, Congress should enact legislation to do so.
3. FDA should develop and implement a comprehensive strategy to collect, analyze, and act on medical device postmarket performance information.
4. FDA should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed.
5. FDA should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of class II devices.
6. FDA should develop and implement a program of continuous quality improvement to track regulatory decisions on medical devices, identify potential process improvements in the medical device regulatory framework, and address emerging issues that affect decision making.
7. FDA should commission an assessment to determine the effect of its regulatory process for class II devices on facilitating or inhibiting innovation in the medical device industry.
8. FDA should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices.
9. FDA should promptly call for PMA applications for or reclassify class III devices that remain eligible for 510(k) clearance.

Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. (Docket No. FDA-2011-N-0556)

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