Explore the medical device requirements currently available for United States, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Indefinite With Annual Establishment Maintenance
510(k), De Novo and PMA are not ordinary annually renewed product authorizations; establishments register and list annually and PMA supplements/annual reports apply as relevant.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Failure to maintain establishment registration/listing or required PMA obligations disrupts lawful marketing, but this is not a simple product-certificate expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Annual establishment registration/listing update; product-specific continuing obligations.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
510(k) has no supplement mechanism; document minor changes and submit a new 510(k) when required.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Communication Liaison Only
U.S. agent
Yes For Foreign Establishment
Communications And Inspection Liaison Not 510k Holder
Initial Importer Is Distinct Role
Distributor Is Distinct
May Be Same Company But Legal Roles Differ
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
FURLS DRM Agent Update And Confirmation
no
The U.S. agent does not assume MDR reporting or 510(k) responsibilities merely by appointment.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which label and IFU elements, languages, symbols, and translation controls apply?
English; devices sold solely in Puerto Rico/territory may use the predominant language under the rule; foreign-language labelling triggers complete required content in that language
English
Verified Official
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
