Reporting of Computational Modeling Studies in Medical Device Submissions; Draft Guidance for Industry and
Citation: "79 FR 3211"
Document Number: "Docket No.
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by
ADDRESSES: Submit written requests for single copies of the draft guidance document entitled "Reporting of Computational Modeling Studies in Medical Device Submissions" to the
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION: There has been an increased interest in the use of CM&S studies as a tool to support medical device applications, as evidenced by the increase in the number of computer modeling test reports submitted in medical device applications.
CM&S studies have traditionally been used in the areas of fluid dynamics (e.g., shear stress and stagnation calculations in ventricular assist devices), solid mechanics (e.g., maximum stress locations in a hip implant), electromagnetics and optics (e.g., radiofrequency dosimetry in magnetic resonance imaging, fluence for fiber optic spectroscopy devices), ultrasound propagation (e.g., absorbed energy distribution for therapeutic ultrasound), and thermal propagation (e.g., radiofrequency and laser ablation devices). The purpose of this draft guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used as valid scientific evidence to support medical device submissions. Moreover, this draft guidance is intended to help improve the consistency and predictability of the review of computational modeling and simulation studies and to better facilitate full interpretation and complete review of those studies.
The draft guidance provides a general outline of information that should be included in a CM&S report, written in general terms to capture reporting for any modality. The guidance also includes five subject matter appendices that provide more background, structure, and specific terminology for modeling and simulation modalities that are widely used in regulatory submissions, including fluid dynamics and mass transport; solid mechanics; electromagnetics and optics; ultrasound; and heat transfer.
II. Significance of Guidance
This draft guidance is being issued consistent with
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive "Reporting of Computational Modeling Studies in Medical Device Submissions," you may either send an email request to firstname.lastname@example.org to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1807 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of information found in
Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the
Assistant Commissioner for Policy.
[FR Doc. 2014-00874 Filed 1-16-14;
BILLING CODE 4160-01-P
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