Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of regulatory strategy can lead to the product not being cleared for market in the desired countries, not being released to market on time because of regulatory hiccups that were not anticipated, and/or being released to the market with inadequate claims such that the product does not fulfill the need of the target market, thereby not selling. Many times during development there are disconnects between marketing expectations and engineering development plans. A thorough regulatory strategy will not only document the regulatory pathways, but also align the new product development team on critical product requirements (intended use, claims, indications, release countries, etc.) and tracks risk items for the selected regulatory pathways. A regulatory strategy is one location where these items can be aligned on at least at the highest product requirement level to ensure a smooth start for development. Periodic updates are very important. When changes are proposed in design, intended use, or claims or changes occur in the regulatory environment, an update to the strategy and proactive communication to the product development team will maintain alignment of the regulatory activities and business strategies, creating an efficient pathway to market.

Following are ten key recommendations for a team to consider when creating an effective Regulatory Strategy.

1. Be absolutely certain the product is indeed a Medical Device. The intended use is the critical item in determining whether the product is a device or not.

FDA defines medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease of other condition, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, intended to affect the structure or any function of the body or man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

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