Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval Prostatic Hyperplasia -- therapy United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- As men age, the prostate enlarges over time obstructing the prostatic urethra resulting in anatomic and functional changes in the bladder. The resulting condition, known as benign prostatic hyperplasia (BPH), can be associated with decreased peak urinary flow rate (Qmax) and increased post void residual urine (PVR). Men with BPH experience bothersome lower urinary tract symptoms (LUTS) that affect their quality of life by disrupting sleep patterns or interfering with daily activities. The development of LUTS is a complex process that involves the interaction of prostatic enlargement and bladder outlet obstruction with age-related effects on the bladder and nervous system. Although BPH is uncommon in young men, it is remarkably common in older men. Epidemiological studies estimate that 50% of men have histological BPH by age 60. The prevalence increases to 90% in men over 85. Similar to the histological evidence, the prevalence of LUTS and other clinical indicators of BPH increases with age and is similar across various countries and ethnic groups studied. Therefore, BPH is considered a significant medical condition that has, and will continue to have, considerable public health impact. A well-designed, scientifically sound investigational plan, both non-clinical and clinical, is essential to evaluate the safety and effectiveness of a medical device intended to treat BPH. Prior to use in humans, it is essential to demonstrate that the device will function as intended in its environment of use. The design of medical devices involves the development and verification of a battery of specifications that define basic safety and performance requirements of the device. Most design specifications are validated in non-clinical testing, which allows assessment of device function and safety under controlled circumstances. Additionally, a comprehensive nonclinical battery of testing provides a foundation for evaluating future changes to the device. The ultimate goal when conducting a clinical investigation of a device to treat BPH is to design a study using objective, unbiased outcomes to measure the safety and effectiveness of treatment. Major challenges faced when designing a clinical study to assess the safety and effectiveness of a BPH device include the placebo effect and spontaneous remissions that commonly occur with BPH, the inherent variability and subjectivity of the typical outcome measures commonly used to assess the effectiveness of treatment, and the availability of effective treatments for BPH. This guidance identifies the key features of non-clinical and clinical investigational plans used to support investigational device exemption (IDE) applications, premarket approval applications (PMAs), De Novo classification requests, and some premarket notification (510(k)) submissions for devices used in the treatment of BPH. Some recommendations in this document may not apply to a particular device, and additional recommendations may be appropriate for novel device types or technologies. FDA will consider alternative non-clinical and clinical testing when the proposed alternatives are supported by an adequate scientific rationale. We encourage you to contact DHT3B, the Division of Reproductive and Urology Devices, when designing your clinical investigation and prior to submission of an original IDE application.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (37 pages)).
- NLM Unique ID:
- 9918351274806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274806676