The FDA wants you to invite them for a formal training visit to your research, clinical, manufacturing and health care facilities to observe firsthand how medical devices are designed, developed and utilized.
FDA Wants an Invitation for a Visit
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They (promise/swear/cross-their-hearts-and-hope-to-die) that these visits are not a mechanism for the agency to inspect, assess, judge, or perform a regulatory function (i.e., compliance inspection), but rather, are an opportunity to provide the FDA review staff a better understanding of the products they review.
The invitation, announced on April 2, 2013 is part of the agency’s Experiential Learning Program (ELP) intended to provide staff at the FDA’s Center for Devices and Radiological Health (CDRH) with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices they review, and the challenges faced throughout development, testing, manufacturing, and clinical use.
This is all part of an effort by the agency to increase focus on the “promote” part of their mission to protect and promote public health. The CDRH is supposed to assure that patients and providers have timely and continued access to safe, effective, high-quality medical devices and safe radiation-emitting products. In support of this mission, the center launched various training and development initiatives to enhance performance of its regulatory review staff and other staff involved in the premarket review process. The ELP is one of those programs.
Submit either an electronic or written request for participation in this program by May 2, 2013. The request should include a description of your facility relative to product areas CDRH regulates. Please include the Area of Interest/Medical Device or Technology (identified in table 1 or 2 in the link below) that the visit will demonstrate to CDRH staff.
The electronic requests should go to: http://www.regulations.gov. Written requests should go to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852.
For further information, contact: Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993-0002, 301-796-6965, FAX: 301-827-3079, Latonya.powell@fda.hhs.gov.
To read the notice in the Federal Register, click here.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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