The FDA opened a comment period on its device reclassification process yesterday, according to a MassDevice report.
The reclassification process is the agency's procedure for handling requests that a medical device be subject to more or less regulation. Devices lower on the scale are subject to less regulation and often pass through the approval process quicker. The comment period runs through Jan. 2012.
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10 Recent FDA Drug and Medical Device Decisions
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The reclassification process is the agency's procedure for handling requests that a medical device be subject to more or less regulation. Devices lower on the scale are subject to less regulation and often pass through the approval process quicker. The comment period runs through Jan. 2012.
Related Articles on Medical Devices:
10 Recent FDA Drug and Medical Device Decisions
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies