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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. Alex: Great story.

IT 102
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This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law

Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.

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New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) Exemption

FDA Law

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. When this author read the January Notice, it seemed like an ill-thought-out proposal.

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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c).