MedicaSafe, Inc.: NDA 220184

We acknowledge receipt of your ss, amendment containing draft labeling, in response to our proposed revisions date: ae This amendment was not reviewed for this action.

Based on our review of your Human Factors (HF) Validation Study, we have the following recommendation:

Based on the use-related risk analysis (URRA), if the user uses an improper technique while interacting with the product (7 Mi), cartridge), there is risk of opioid withdrawal symptoms.

Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1 (a)].

FDA has determined that (PW is a product that has serious risks (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients' decisions to use or continue to use |)", and that the drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.

REMS, such as the rationale for and supporting information about the design, implementation, and plan for REMS assessment.

Once FDA finds the content acceptable and determines that the application can be approved, we will include the REMS document and REMS materials as an attachment to the approval letter.

Therefore, update your labeling to include the Software Version.