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Device, Fertility Diagnostic, Contraceptive, Software Application

Page Type
Product Code
Definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Physical State
Software application, the physical platform may vary (e.g., mobile phone, PC, tablet, etc…)
Technical Method
Algorithm transforms user data into user-specific information regarding fertility and provides timeframes when pregnancy is unlikely.
Target Area
Not Applicable
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5370
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5370 Software application for contraception

§ 884.5370 Software application for contraception.

(a) Identification. A software application for contraception is a device that provides user-specific fertility information for preventing a pregnancy. This device includes an algorithm that performs analysis of patient-specific data (e.g., temperature, menstrual cycle dates) to distinguish between fertile and non-fertile days, then provides patient-specific recommendations related to contraception.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the contraceptive effectiveness of the software in the intended use population.

(2) Human factors performance evaluation must be provided to demonstrate that the intended users can self-identify that they are in the intended use population and can correctly use the application, based solely on reading the directions for use for contraception.

(3) Software verification, validation, and hazard analysis must be performed. Documentation must include the following:

(i) A cybersecurity vulnerability and management process to assure software functionality; and

(ii) A description of the technical parameters of the software, including the algorithm used to determine fertility status and alerts for user inputs outside of expected ranges.

(4) Labeling must include:

(i) The following warnings and precautions:

(A) A statement that no contraceptive method is 100% effective.

(B) A statement that another form of contraception (or abstinence) must be used on days specified by the application.

(C) Statements of any factors that may affect the accuracy of the contraceptive information.

(D) A warning that the application cannot protect against sexually transmitted infections.

(ii) Hardware platform and operating system requirements.

(iii) Instructions identifying and explaining how to use the software application, including required user inputs and how to interpret the application outputs.

(iv) A summary of the clinical validation study and results, including effectiveness of the application as a stand-alone contraceptive and how this effectiveness compares to other forms of legally marketed contraceptives.

[84 FR 7995, Mar. 6, 2019]

Device, Fertility Diagnostic, Contraceptive, Software Application

Page Type
Product Code
Definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Physical State
Software application, the physical platform may vary (e.g., mobile phone, PC, tablet, etc…)
Technical Method
Algorithm transforms user data into user-specific information regarding fertility and provides timeframes when pregnancy is unlikely.
Target Area
Not Applicable
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5370
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5370 Software application for contraception

§ 884.5370 Software application for contraception.

(a) Identification. A software application for contraception is a device that provides user-specific fertility information for preventing a pregnancy. This device includes an algorithm that performs analysis of patient-specific data (e.g., temperature, menstrual cycle dates) to distinguish between fertile and non-fertile days, then provides patient-specific recommendations related to contraception.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the contraceptive effectiveness of the software in the intended use population.

(2) Human factors performance evaluation must be provided to demonstrate that the intended users can self-identify that they are in the intended use population and can correctly use the application, based solely on reading the directions for use for contraception.

(3) Software verification, validation, and hazard analysis must be performed. Documentation must include the following:

(i) A cybersecurity vulnerability and management process to assure software functionality; and

(ii) A description of the technical parameters of the software, including the algorithm used to determine fertility status and alerts for user inputs outside of expected ranges.

(4) Labeling must include:

(i) The following warnings and precautions:

(A) A statement that no contraceptive method is 100% effective.

(B) A statement that another form of contraception (or abstinence) must be used on days specified by the application.

(C) Statements of any factors that may affect the accuracy of the contraceptive information.

(D) A warning that the application cannot protect against sexually transmitted infections.

(ii) Hardware platform and operating system requirements.

(iii) Instructions identifying and explaining how to use the software application, including required user inputs and how to interpret the application outputs.

(iv) A summary of the clinical validation study and results, including effectiveness of the application as a stand-alone contraceptive and how this effectiveness compares to other forms of legally marketed contraceptives.

[84 FR 7995, Mar. 6, 2019]