Blog
Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.
- All
- FDA Approval
- FDA Enforcement
- FDA News Update
- FDA Q&A
FDA Approved Meaning
One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there is no single…
FDA Due Dilligence Review
Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic company, you need to…
FDA Shutdown
The partial government shutdown, now in its 24th day with impacts at the FDA felt across all its Centers. Currently, with the FDA shutdown, most if…
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 FDA Atty…
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
The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was issued in response…
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 here). Although…
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 with a summary of…
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 Bitcoin or…