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Top priority: Food Safety Modernization Act (FSMA) “Proactive and Preventative” 1) Evaluate Hazards 2) Think what are the preventative steps: documentation of monitoring must be available for FDA inspector 3) Inspection and compliance Foreign inspection included; plan to do 9,600 foreign inspections next 5 years 4) Import Food Safety: Foreign Suppliers must hold the same standard as US domestic suppliers so that US customers will not go for cheaper foreign made products. 2019 10) FDA strategy going forward: Specialization Field inspectors will be specialized; no loss of time before inspections; each FDA District will be assigned a specialty area. Regulatory submission of Mobile Medical Device Application Important: User manual, Software interfaces, Cyber-security integrity Product owner must select high quality CM: owner is ultimately responsible for the products in commerce.

5) Response: FDA has the authority to recall, if companies do not voluntarily recall. 6) Expenses: FDA will charge companies for : Re-inspection if no corrections made since the first inspection; Cost of recalls and subsequent inspection fees; Imports recall and re-exportation charges 7) Imports: third party certification by FDA authorized party; High-risk imports must come with 3rd party Certification 8) Importer: FDA has authority to deny entry only with presumption of suspicion and no Lab tests are needed 9) FSMA timetable: Foreign Supplier Verification: Large firms ? Regulatory challenges: Organic Product, Organic Crops, Gluten Free, Calif. Useful FDA Guidance for both CM and product owner: Contract Manufacturing Arrangement for Drugs: Quality Agreements(PDF)Existing: 21 CFR part 110 (1986) Food c GMP New: 21 CFR part 117 (proposed); important: Subpart C Hazard Analysis Applicable to both Domestic and Foreign facilities Foreign Supplier Verification Program (FSVP) FDA accreditation of 3rd party audits: the supplier must meet FDA standards, Audit records need to be in English (1) What are your desired claims?

FDA Guidance Mobile Medical Applications (Feb 2015) If an App is for a medical device, then FDA regulates.

(2) Select the right Target study population; for US clinical studies, must choose "healthy" subjects; Healthy subjects who are looking to improve some aspects of their health (3) Study endpoint should not be disease end point; use a surrogate endpoint or a marker "Avoiding Regulatory Nightmare; Study Endpoints and Claims, Substantiation for Clinical Trials"(Free white paper) * Please note that this is an educational conference.

Both public and private presenters discussed regulatory aspects of product development.

The organizers are not endorsing the presenter’s services.

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