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Latest Devices · Pre-marketing A 510(k) is not an approval. It is a comparison.

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2 articles

  1. Jul 162026
    Devices · Pre-marketing

    What a 510(k) actually is — and what clearance means

    Everyone calls it “FDA approval for devices.” It is neither an approval nor about your device alone — and that difference decides the whole file.

    Gloved hands loading sample tubes into a benchtop laboratory centrifuge
  2. Jul 152026
    Drugs · Pre-marketing

    What an IND actually is — and the 30-day clock

    Most explanations call it “an application to the FDA.” That framing is why people wait for a letter that never comes.

    A gloved hand completing a multi-page laboratory record

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