PMA上市前批准
PMA is the U.S. Food and Drug Administration premarket approval pathway for high-risk Class III medical devices that do not qualify for 510(k) substantial-equivalence review. In regulatory translation, it appears in clinical study reports, labeling, manufacturing summaries, and post-approval study documents, all of which must be filed in English for FDA review and updated through supplements when changes occur after approval.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
PMA appears in U.S. regulatory submissions for high-risk devices, including clinical trial documents, patient labeling, and manufacturing site descriptions. Translators may support investigator-facing materials or summarize non-English clinical data into English sections, but must not alter efficacy or safety claims during summarization; the terminology also appears in post-approval study progress reports.
Translation checks
A frequent error is treating PMA as an extension of 510(k) or translating 'approval' loosely in a way that implies broader marketing authorization than the FDA granted. This can misstate the device’s approved indications and create compliance risk if promotional or labeling text is not limited to the PMA-approved claims and conditions.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.