Description
Additional copies are available from:Office of Policy, Office of the Commissioner1Food and Drug Administration5600 Fishers LaneRockville, MD 20857(301) 827-3360
Scope & Applicability
Product Classes
2Products for which batch/lot information is particularly important
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
2User role with specific access privileges
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Recommended marking for electronic recall communications.
Identified Hazards
Hazards
1The underlying concern necessitating rapid communication.
Related CFR Sections (4)
- 21CFR1271.440§ 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.
(a) Upon an agency finding that there are reasonable grounds to believe that an HCT/P is a violative HCT/P because it was manufactured in violation of the regulations in this part and, therefore, the conditions of manufacture of the HCT/P do not provide adequate protections against risks of communicRead full regulation →
- 21CFR810.15§ 810.15 Communications concerning a cease distribution and notification or mandatory recall order.
(a) General. The person named in a cease distribution and notification order issued under § 810.10 or a mandatory recall order issued under § 810.13 is responsible for promptly notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. In accordRead full regulation →
- 21CFR200.5§ 200.5 Mailing of important information about drugs.
Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required to mail important information about drugs to physicians and others responsible for patient care. In the public interest, such mail should be distinctive in appearance so that it will be promptly reRead full regulation →
- 21CFR7.49§ 7.49 Recall communications.
(a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In genRead full regulation →
Related Warning Letters (2)
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Chapter 1 - General (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003) (Status: Final)
- Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)