Dan Crenshaw
09/26/2024 | Press release | Distributed by Public on 09/26/2024 10:07
Congressman Crenshaw & Congresswoman Craig Lead Letter to FDA Regarding the Third-Party Review of Medical Devices
Congressman Dan Crenshaw (TX-02) and Congresswoman Angie Craig (MN-02) sent a letter to the Food and Drug Administration (FDA) requesting information on the agency's plan for their medical device third-party review program. This program allows qualified private-sector reviewers to review low-risk medical devices, to increase expedited review of medical devices at the FDA.
"We share your interest in advancing access to medical innovation and write regarding your recent comments on the 510(k) Third-Party Review program," Crenshaw and Craig wrote. "We agree that the principles of the Third-Party Review Program have great promise for increasing efficiency in device regulation. In particular, we see the promise of this program to streamline the review of well-understood device types, which can, in turn, maximize the FDA's capability to address higher-risk devices … With this in mind, we suggest that the agency consider potential solutions and answer the following questions regarding its intentions expressed in the LDT Final Rule."
Read the full letter here.
As a member of the House Energy and Commerce Subcommittee on Health, Rep. Crenshaw has led on improving access to medical innovation. This includes sponsoring legislation to expand access to breakthrough therapies, enhance the FDA's review of personalized medicine, and ensure that we are addressing chronic disease - including traumatic brain injury and cancer.
"We share your interest in advancing access to medical innovation and write regarding your recent comments on the 510(k) Third-Party Review program," Crenshaw and Craig wrote. "We agree that the principles of the Third-Party Review Program have great promise for increasing efficiency in device regulation. In particular, we see the promise of this program to streamline the review of well-understood device types, which can, in turn, maximize the FDA's capability to address higher-risk devices … With this in mind, we suggest that the agency consider potential solutions and answer the following questions regarding its intentions expressed in the LDT Final Rule."
Read the full letter here.
As a member of the House Energy and Commerce Subcommittee on Health, Rep. Crenshaw has led on improving access to medical innovation. This includes sponsoring legislation to expand access to breakthrough therapies, enhance the FDA's review of personalized medicine, and ensure that we are addressing chronic disease - including traumatic brain injury and cancer.