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Pre-Market Approval (PMA)

Pre-Market Approval [ENGLISH]

Rigorous process by which the US Food and Drug Administration (FDA) evaluates the safety and effectiveness of Class III medical devices, which are considered high-risk devices.

Pre-Market Approval [SWEDISH]

Rigorös process genom vilken US Food and Drug Administration (FDA) utvärderar säkerheten och effektiviteten hos medicintekniska produkter i klass III, som anses vara högriskprodukter.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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