Medical Device Link.

REGULATORY OUTLOOK

Ways to avoid errors in a preclinical evaluation submission include the following:

• Do your homework. Use resources on FDA’s Web site to learn about the submission requirements for a particular device. If you don’t have the regulatory expertise in-house, find someone who does (e.g., other companies interested in your device, regulatory consultants, professional societies, or trade associations such as AdvaMed or MDMA).
• Proofread documents several times. Individuals not familiar with the material should be recruited to review test reports and regulatory submissions. If the information is unclear to them, it probably won’t work for FDA reviewers either. Sloppy grammar, spelling errors, poor organization, or lack of pagination make the reviewer’s job more difficult, which is never good for a sponsor. It can also potentially raise questions as to the quality of the data in the submission and of the device itself.
• Establish a dialogue and collaborative working relationship with the FDA branch chief and reviewers who work on your submissions. Don’t think of the agency as a “big black box” waiting to reject your submissions. FDA is made up of individuals with a wide variety of experiences and expertise, all of whom can be incredibly helpful to you in your device development plan. Device development and testing should be an interactive process between companies and the agency. Use FDA as a resource to avoid wasting money, time, and effort on uninformed choices in a preclinical evaluation.