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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.
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Redacting a FOIA Request
Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…
FDA Approved Meaning
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…
FDA Due Dilligence Review
FDA Due Diligence Review Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic…
FDA Shutdown
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,…
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…