510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Submit news

Send us what happened. Submitting is free, it is not sponsorship, and it does not buy coverage.

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What we cover

  • Clearances, approvals and recalls, and what caused them.
  • Plant openings, expansions, line additions and closures.
  • Mergers, acquisitions, funding and executive moves.
  • Standards revisions and regulatory change: FDA guidance, QMSR and ISO 13485, EU MDR, the ISO 11607, 11135, 11137 and 10993 families, ASTM methods, UDI.
  • Process and equipment news: molding, extrusion, machining, electronics, catheter and tubing, cleanroom assembly, automation, additive, software and firmware, test.
  • Packaging, sterile barrier systems, sterilization capacity and validation.
  • Supply chain: nearshoring, tariffs, materials availability, vendor consolidation.
  • Events: shows, conferences, courses and workshops.

What makes a release usable

Most releases do not run as sent. They run as a brief, rewritten, with the claims checked. A release with these in it is far more likely to become one.

  • What actually happened, and when. A date, a place, a number. A new capability is news; a new adjective is not.
  • A link to the primary source. The clearance, the certificate, the filing, the standard, the study. We link every factual claim to the document behind it, and a claim we cannot link is a claim we do not run.
  • Standards by number and year. ISO 11607:2019, not the packaging standard.
  • A named contact who can answer a technical question. Not only the agency inbox.
  • No vendor adjectives. We take them out anyway. Sending them costs you the space they used.

What happens next

Newsroom not staffedAs of the newsroom has not been staffed and nobody has been named to read an arriving submission, so nothing sent now is read by an editor on arrival. The rules below are what the first editor will apply.

We may cover it, rewrite it as a brief, hold it for a themed month, or not run it. A submission is not a commitment to publish, and we do not state a turnaround, because there is no committed clock behind one.

Anything we do run is independent editorial, held to the ethics policy. If you want a guaranteed placement, that is sponsored content, it is labeled as sponsored, and it lives on advertise.

Practitioner columns are a separate path. They run in Perspectives, they are labeled as contributed, and they carry the author’s employer.

Where to send it

By email, to [email protected], or through the form below. Both reach the same mailbox and the same person; the form asks you to confirm your address first, and takes no attachments. What we hold about a submission, and for how long, is on privacy.

A person, not only the agency inbox. The rules above say why.

A confirmation link goes there. Nothing reaches the newsroom until it is opened, and a submission whose link is never opened is deleted when the link expires.

A date, a place, a number. Up to 200 characters.

As you would send it, up to 6000 characters. Standards by number and year. No attachments: link the document instead.

The clearance, the certificate, the filing, the standard, the study. Optional, and the single thing most likely to make a release usable.

Sending asks the address above to confirm. What we hold about a submission, and for how long, is on privacy. Submitting is free, is not sponsorship, and does not buy coverage.