Interesting Discussion Requirements for selling a Food product in USA

DannyK

Trusted Information Resource
#1
A company in Canada wishes to sell a GRAS product in USA.

Are there regulatory requirements for interstate marketing a GRAS food product? Or is FDA registration of product and establishment enough?”

Note that the supplier is GMP.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
D What are the requirements for selling Alcohol Swabs in USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
C Labeling requirements when selling demo Medical Device equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
I Requirements for selling Class I Medical Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 4
B Regulatory Requirements are for selling Medical Devices in the Ukraine? Other Medical Device Regulations World-Wide 9
Q Labeling requirements when selling products manufactured in China Various Other Specifications, Standards, and related Requirements 4
K OEM specific requirements Customer and Company Specific Requirements 3
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 0
M IEC 61000-4-2: Requirements for coating declared as insulating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
S Translational Requirements - Article 120 EU Medical Device Regulations 2
G PMS Report - requirements EU Medical Device Regulations 2
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
K No IFU, where the requirements would go? EU Medical Device Regulations 5
NDesouza AS9100 - D Capacity Planning Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
P IFU Translation Requirements for EU EU Medical Device Regulations 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
A Digital Timer Calibration Requirements General Measurement Device and Calibration Topics 3
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
W Isolation requirements for Wireless ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
N Calibration Requirements for Production Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Similar threads


















































Top Bottom