Premarket Approval (PMA) Submissions
For high-risk (Class III) medical devices, a Premarket Approval (PMA) is the most rigorous FDA pathway.
We offer complete PMA support including:
- Pre-submission consultation: Engage early with FDA to address key questions
- PMA compilation: Complete and organise all required modules
- Preclinical testing: Manage testing strategy and execution
- Clinical investigation support: From design to data interpretation
- Advisory panel preparation: Prepare materials and provide representation
- Annual reporting: Fulfil all post-market PMA compliance needs
- PMA Supplements: Submit updates for design, manufacturing, or labelling changes
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Featured case studies
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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