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Will FDA/CMS Parallel Review Idea Make Headway This Time?

This article was originally published in The Gray Sheet

Executive Summary

The possibility of simultaneous FDA and CMS evaluations of new devices is back in the front of agency officials' minds after a series of fits and starts over the past several years, says CMS Chief Medical Officer Barry Straube

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Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.

Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.

FDA And CMS Agree To Share Data Routinely In Step Toward Parallel Reviews

Routine sharing of data between FDA and CMS will be possible for the first time under a June 23 memorandum of understanding that could serve as a first step toward parallel reviews for marketing approval and Medicare coverage

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