Draft Guidance for Industry-Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
The Food and Drug Administration (FDA) has announced the availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.''
FDA has developed this draft guidance document
- To provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices.
- To improve the predictability, consistency, and transparency of the premarket review process.
- The processes discussed in this guidance are applicable to devices subject to premarket approval (PMA) applications and, in limited cases, devices subject to premarket notification (510(k)) requirements.
- This guidance applies to both diagnostic devices and therapeutic devices. Although guidance is not binding, the concepts and factors described herein generally capture how benefit-risk determinations are made by FDA during the premarket review process.
Under §513(a) of the Federal Food, Drug & Cosmetic Act (“the FD&C Act”), FDA determines whether PMA applications provide a “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use”.
To aid in this process, PMA applicants submit valid scientific evidence, including one or more clinical investigations where appropriate, which FDA reviews to determine whether “the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.”FDA staff review the data submitted as part of the PMA and determine – based on a number of factors – if the data support the claims made by the sponsor for the device, i.e., intended use and/or indications for use, and data analysis demonstrates that the benefits of the device outweigh its risks. This process may also occur on a case-by-case basis in the review of 510(k) devices when there are differences between the target device and the predicate device that can adversely affect the safety and/or effectiveness of the target device.
PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR Doc No: 2011-20652
Or you can send your comments within 90 days at email@example.com and REF: Factors to Consider when Making Benefit-Risk Determinations.
For more information on this guidance you can go to the following link:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM267872.pdf