Guide pour l’industrie: Questions et réponses concernant le Registre de denrées alimentaires à signaler Reportable Food Registry (RFR) tel qu’établi par le Food and Drug Administration Amendments Act de 2007 (FDAAA) (2ème édition) | Guideline Explorer

Scope & Applicability

Product Classes

6

animal feed

Product for which manufacturers must identify transporters.

veterinary drugs

Category of products covered by the safety reporting portal.

Denrée alimentaire à signaler

Food that may cause serious adverse health consequences or death.; Food products that meet the criteria for reporting to the RFR; Produit présentant une probabilité raisonnable de causer des conséquences graves sur la santé.

Supplément diététique

Excluded from RFR but subject to adverse event reporting under 21 U.S.C. 379aa-1.

Préparation pour nourrissons

Excluded from RFR but subject to notification under 21 CFR 107.240.

Infant Formula

The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.

Stakeholders

7

responsible party

Entity required to submit clinical trial registration and results information.; Entity required to submit clinical trial information.

agent de santé publique

Agents locaux, fédéraux ou nationaux pouvant soumettre des rapports volontaires.

agents de santé publique

Local, state, or federal officials involved in food safety

source précédente immédiate

Immediate previous source in the supply chain

destinataire suivant immédiat

Immediate subsequent recipient in the supply chain

public health officials

Entities that may submit reports to the RFR.

Partie responsable

The person responsible for submitting RFR reports, typically the facility registrant.; Responsible party required to submit reports to the FDA; Entity required to submit reports and notifications under Article 417; Entité ayant l'obligation de soumettre des rapports au RFR.

Regulatory Context

Attributes

4

Class I recall

Situation with reasonable probability of serious adverse health consequences or death.

de minimis

Nature d'activité jugée mineure exemptant d'enregistrement.

numéro de lot

Product identification element required in notifications

date limite de consommation

Expiration date or shelf life information on packaging

Identified Hazards

Hazards

1

undeclared allergen

Major food allergens not listed on labeling.

Related CFR Sections (5)

21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read full regulation →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR1.225§ 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United StatRead full regulation →
21CFR107.240§ 107.240 Notification requirements.
(a) Telephone report. When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formuRead full regulation →
21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →