Description
For the past several years it has been the Food and Drug Administration's position that articles intended to be used for ear-piercing were devices which should be restricted to prescription dispensing in accordance with 21 CFR 80l.l09. The Food and Drug Administration has attempted to regulate such devices on an ad hoc basis, but this has not resulted in any broad compliance by the industry.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Devices compared to reference methods or gold standards
The emphasis is on FDA's particular concerns in the review of cytology devices for gynecologic specimens.
Subject of the points-to-consider document; Guidance document title and subject of clinical study requirements; The primary subject of the guidance document.; Subject of the guidance document regarding points to consider for regulatory submission.
Stakeholders
3Entity responsible for submitting applications under section 524B
Role responsible for screening specimens; Laboratory professional involved in screening and interpreting slides.
professional who views the image on a computer monitor to arrive at a diagnosis
Regulatory Context
Regulatory Activities
4Regulatory filing such as a 510(k) or PMA submitted to the FDA.; Submission including ASCA testing results
Premarket notification submission type
A medical device submission type (IDE).
Premarket Approval Application
Document Types
4This points-to-consider document supplements existing FDA guidance for premarket submission of in vitro diagnostic devices.
Definitions, algorithms, and data elements should be included in the study protocol.
Section of the guidance detailing study design requirements
Required documentation for using negative archival slides
Attributes
5A functional role of sodium in food
Evaluation required for all gynecologic cytology devices submitted for FDA approval.
the biomarker's clinical sensitivity, specificity, and positive and negative predictive values should be well characterized
used to inform the choice of a biomarker cutoff
Required data for pediatric population estimates
Technical Details
Testing Methods
9Provide real-time studies from three different manufacturing lots which include data to demonstrate the stability.
Conventional methodology used as a baseline for comparison with new devices.
Used to verify abnormal cells identified by computer-assisted devices.
Conventional method used as a reference or basis for sampling; Conventional reference method for cervical screening
Automated method compared against manual reading
Required analysis for ordinal classification data
A reference method for accuracy, though less than a gold standard.
A method used for confirmation of cytology results.
Acceptable surrogate reference method for specimen accuracy.
Processes
4women with ASC-US cytology from Ob/Gyn clinics will proceed to colposcopy; send a subset of those women to colposcopy
In vitro methods for product quality and performance assessments
avoiding morbidity associated with an immediate biopsy
Processing of cervical cells from mucus and other materials
Clinical Concepts
8Over 50 million Pap tests are performed each year.
Data must be provided to assess this factor to establish workload limits.
TBS diagnosis category (ASCUS)
TBS diagnosis category for data stratification
Atypical squamous cells of undetermined significance
Low grade squamous intraepithelial lesion
High grade squamous intraepithelial lesion
Primary end-point for validation of in vitro diagnostic methods
Identified Hazards
Hazards
1Required safety assessment for image interpretation devices
Standards & References
External Standards
2Confirmatory test must be performed according to TBS guidelines; Standard for cervical cytology diagnoses (TBS); TBS categories used for screening diagnoses and reporting cervical/vaginal cytological diagnosis.
The Bethesda System guidelines for confirmatory testing
Specifications
2Define and document a minimum set of metrics (e.g., accuracy)
Define and document a minimum set of metrics (e.g., precision)
Related CFR Sections (3)
- 21CFR884.4530§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a) Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief Read full regulation →
- 21CFR864.3800§ 864.3800 Automated slide stainer.
(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.Read full regulation →
- 21CFR864.5260§ 864.5260 Automated cell-locating device.
(a) Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)Read full regulation →