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Microneedling 510(k)
Microneedling 510(k) The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The…
The Microneedling Classification Update
The FDA formally issued a Microneedling Classification Order on Friday (link here). Unlike before, the Final Order is now codified in the Code of Federal Regulations (CFR)….
Microneedling Classification Order
Microneedling Classification Order The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was…
Government Shutdown
Government Shutdown A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and…
FDA Warning Letters 2017
FDA Warning Letters 2017 FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along…
FDA Bitcoin
FDA Bitcoin FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether…
CDER Direct
CDER Direct CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings….
FDARA Marketing Status Report
FDARA Marketing Status Report FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed…
FDA Homeopathic Drugs
FDA Homeopathic Drugs FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject…
FDA Cosmetic Safety and Modernization Act (S2003)
FDA Cosmetic Safety and Modernization Act (S2003) Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill,…
FDA Microneedling Guidance
FDA Microneedling Guidance FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can…