Premarket Approval

The PMA is the most stringent of the FDA's device marketing applications and applies to Class-III devices. A PMA often involves a new concept or technology, with no predicate device on the market, and involves a high risk to the patient. The PMA application requires extensive documentation. Results from clinical (human) trials must include study protocols, safety and efficacy data, adverse reactions and complications, device failure and replacements, and more. Laboratory studies on toxicology, microbiology, biocompatibility, stress-wear, shelf life, and preclinical (animal) tests must be also presented. The FDA also carefully examines the integrity of the entire research methodology process, study conclusions, and data presentation.

Taking a product from development to successful PMA usually requires at least seven years. The average time to FDA approval once all required testing is completed and submitted for review is 2-5 years [2. Lewin, N. Faster approvals seen for drug and device combination products. BBI Newsletter 2003; 26(9).] Given the time and expense involved, a company must try to predict whether their product, nearly a decade in the future, will fill a significant market need and be profitable. Examples of PMA devices approved in the past include an artificial urinary sphincter; a penile inflatable implant; and electro-optical sensors for in vivo detection of cervical cancer. [3. http://www.fda.gov/cdrh/devadvice/pma/ (accessed October 2005).]

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