Scope

The U.S. Food & Drug Administration does have the power to clear medical devices for sales in the U.S. A prevailing attitude by innovators is to avoid or delay submitting your product to the scrutiny of the US Food & Drug Administration. This avoidance or delay may have merit in remote instances, however, we have developed an informed perspective  from having been through this process on so many occasions.

Product Approvals

Even children’s toys require some product approval. Complex products or medical product must pass one or more product approvals from regulatory agencies. If approvals are not required  by law, then approvals will be required by your liability insurance underwriters.

If you postpone addressing this issue, your costs to meet these requirements will multiply as the product matures. If you address this issue early, then the Food & Drug Administration virtually becomes your partner in development. Once your device is FDA cleared, then other regulatory agencies may accept your FDA clearance, thus saving a compilation of approvals.

Real Commercialization

The most important aspect of commercializing your medical invention is:   Food & Drug Administration “approval”.

No other agency can legitimize your product like an FDA clearance. Without FDA clearance, your medical device is not legitimate. With Food & Drug Administration clearance, your product is legitimate. The Food & Drug Administration clearance alone will separate any medical device into two categories:

·        those devices with FDA clearance appear legitimate to investors,

·        those devices without FDA clearance appear risky, speculative and uncertain.