FDA Los Angeles District Office and Orange County Regulatory Affairs Discussion Group
18th Annual FDA-OCRA Educational Conference *
June 3, 2015 Irvine, California
- FDA Los Angeles District, Acting District Director
|FDA Update||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.
5) Response: FDA has the authority to recall, if companies do not voluntarily recall. FDA will charge the costs to the Company.
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 ? by 2017, medium ? 2018, small ? 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.
- Certified Compliance Solutions Mike Swit, Illumina
|FDA Regulation of Mobile Medical Applications||Which Mobile Medical App. does FDA regulate?
FDA Guidance Mobile Medical Applications (Feb 2015)
If an App is for a medical device, then FDA regulates.
Regulatory submission of Mobile Medical Device Application
Important: User manual, Software interfaces, Cyber-security integrity
-International Vitamin Corp.
|Working with Dietary Supplement Contract Manufacturer (CM)||Product owner must select high quality CM: owner is ultimately responsible for the products in commerce.
Regulatory challenges: Organic Product, Organic Crops, Gluten Free, Calif. Prop 65, Non-GMO etc.
Useful FDA Guidance for both CM and product owner: Contract Manufacturing Arrangement for Drugs:
|J. Joseph -Joy’s Quality Management Systems||Industry Challenges to Implementation of New rules resulting from FSMA||Existing: 21 CFR part 110 (1986) Food cGMP
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
|Clinical Study Design for claim substantiation for Dietary Supplements||(1) What are your desired claims?
(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.