“The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers “microneedling” products to be medical devices and subject to regulation.”
Read the full article – Source: FDA Steps in to Regulate Microneedling Devices | RAPS
Read the guidance: Regulatory Considerations for Microneedling Devices – FDA (PDF)
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“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “
This should interest HME professionals:
Read the full article via: Source: 
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.
“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.
