Description
This guidance document is intended to help Food and Drug Administration (FDA) staff develop a request for additional information needed to make a decision on a medical device marketing application in accordance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act (FD&C Act). Such an FDA request for additional information is known as a “deficiency.” In addition, this guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests, in order to make efficient use of industry and FDA’s time. This guidance includes examples of well-constructed deficiencies and industry responses to facilitate an efficient review process. This guidance also details supervisory review, major/minor deficiencies, additional considerations, and prioritization of deficiencies in FDA deficiency letters.
Scope & Applicability
Product Classes
1FDA 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
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
4Standard for PMA approval
Standard for 510(k) clearance
Cybersecurity is part of device safety and effectiveness
Performance parameter for handpiece testing.
Identified Hazards
Hazards
2ESD can damage the battery's electronic components leading to patient harm
can cause nerve root compression and pulmonary embolisms
Related CFR Sections (3)
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR878.4430§ 878.4430 Microneedling device for aesthetic use.
(a) Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems (Status: Final)
- CPG Sec. 345.300 Menstrual Sponges (Status: Final)
- CPG Sec. 355.300 Ion Generating Devices (Status: Final)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Guidance Document for Dura Substitute Devices - Guidance for Industry (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)