Jan 28, 2014

The US Food and Drug Administration has released two new draft guidances for medical device manufacturers that either include computational modeling data in their registration applications or use animal-derived sources in their products.

First, the FDA has published recommendations for what to include and how to format computational modeling and simulation reports for inclusion in 510(k) premarket notification or Premarket Approval (PMA) applications. More uniform processes for compiling and submitting such information will lead to more efficient and consistent market authorization reviews, argues the agency.

The guidance applies to devices that incorporate elements such as fluid dynamics, solid mechanics, electromagnetic or ultrasound properties, or heat transfer components. Reports on computational modeling and simulation studies should include executive summaries, system configuration and properties information, validation data and study results.

Clear FDA recommendations—albeit in draft guidance form—should be seen as a welcome development for manufacturers planning to include computational modeling study data in their US medical device registration applications. The guidelines will hopefully lead to more predictable and consistent reviews of submission materials.

Second, the FDA has updated guidance first issued in 1998 on the use of animal-derived materials in medical device manufacturing to include recommendations to mitigate contamination risks, particularly the role of animal husbandry in the potential spreading of Bovine Spongiform Encephalopathy (BSE, or, more sensationally, Mad Cow Disease) and related diseases.

The guidance recommends that manufacturers of applicable devices keep records of all animal-derived materials used in production: animal species, age, specific tissues used, country of origin and similar information. This information should also be provided in firms’ FDA registration submissions.

All manufacturing control processes, testing results and sterilization methods should also be well documented and reportable to regulators.

Stewart Eisenhart


  • Stewart Eisenhart