Framework for the Safety and Performance Based Pathway
Modernized pathway to facilitate 510(k) Submissions
Safety and Performance Based Pathway when:
New device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than identified predicate
Predicate is within scope of list of eligible device types
Performance criteria align with performance of predicate
New device meets all the FDA-identified performance criteria.
Impact:
Use pathway instead of conducting direct comparison testing to predicate despite technological differences
Will still need to identify a predicate for certain aspects of substantial equivalence, when appropriate.
Steps to strengthen its 510(k) pathway by promoting the use of robust performance criteria and modern predicate devices
Safety and Performance Based Pathway
Expands approach previously applied through Abbreviated 510(k) Program, based on conformity to FDA-recognized consensus standards
Show new device meets FDA-identified performance criteria reflecting current technological principles and the safety and performance of modern predicate devices
May request and review underlying data and testing methodologies for substantially equivalent assessment
Promoting use of more modern predicate devices
Make public a list of devices or manufacturers who make technologies that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)
Consider using other criteria to inform our point of reference?
Promote use of more modern predicates
New authority, such as making at least some older devices ineligible as predicates
Labeling for drugs approved under accelerated approval, reflecting the more frequent use of this pathway for drugs used in certain clinical settings
Focus on indications for drugs approved via accelerated approval based on surrogate endpoint or clinical endpoint other than survival or irreversible morbidity
Example: This indication is approved under accelerated approval based on {state effect on surrogate endpoint or intermediate clinical endpoint that supported the accelerated approval} [see Clinical Studies (14.X)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Considerations:
Limitations of Usefulness and Clinical Benefit : Uncertainty, Continued Approval
When Clinical Benefit Has Been Verified
Withdrawal of an Accelerated Approved Indication: Lack of Evidence Concerning the Withdrawn Indication, Safety Information Concerning the Withdrawn Indication
INDICATION FOR USE: Quantitatively measures the concentration of fat, carbohydrate, and protein in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.
ADDRESSING UNMET NEED:
Some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth
Doctors have access to test to analyze nutrients in breast milk to aid parents and healthcare providers
DESCRIPTION: Breast Milk Macronutrients Test System
Intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants
SAFETY AND EFFECTIVENESS:
N= 112 samples of human milk; comparison of machine vs expected values
Device effective at determining levels of protein, fat and carbohydrate in the milk
However, certain medications taken by nursing mother could interfere with test’s ability
RISKS AND MITIGATIONS:
Incorrect test results: General controls and special controls
Incorrect action based on test results: General controls and special controls
REGULATORY PATHWAY:De Novo request
Regulation Number: 21 CFR 862.1493
Regulation Name: Breast milk macronutrients test system
INDICATION FOR USE: Intended to be used by healthcare professionals as an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers
DESCRIPTION: Pressure ulcer management tool
Prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
RISKS & MITIGATIONS:
Class I (general) controls provide reasonable assurance of safety and effectiveness
Identified risks to health are adverse tissue reaction, transmission of infection between patients, electromagnetic interference with patient monitoring equipment, electrical shock
INDICATION FOR USE: Intended to measure and analyze eye movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
DESCRIPTION:Traumatic brain injury eye movement assessment aid
Prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
RISKS AND MITIGATIONS:
Incorrect or misinterpreted results, including: False positive (brain injury when in fact none is present), False negative (no brain injury when in fact brain injury is present): Clinical performance testing, Software verification, validation, and hazard analysis; Labeling
Interference with other devices: Electromagnetic compatibility (EMC) testing Software verification, validation, and hazard analysis
Electrical shock or burn: Electrical safety testing, Software verification, validation, and hazard analysis
INDICATION FOR USE: Non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
Prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax
Electromagnetic interference with other devices: Electromagnetic compatibility testing, Infection Reprocessing validation, Labeling
Inaccurate images due to either device hardware or software failure/malfunction: Software verification, validation, hazard analysis, Non-clinical performance testing, Labeling
Electrical shock injury or thermal injury: Electrical, thermal, and mechanical safety testing; Software verification, validation and hazard analysis; Non-clinical performance testing; Labeling
Rare Diseases: 34 novel approvals including treatments for of rickets, Fabry disease, phenylketonuria
Infectious Diseases: Notables include treatments for smallpox, malaria, HIV-1, nontuberculous mycobacterial lung disease
Neurological Disorders: Notables include treatment for seizures in Lennox-Gastaut syndrome and Dravet syndrome, migraine, polyneuropathy in hereditary transthyretin-mediated amyloidosis, multiple sclerosis in children
Heart, Lung, and Circulatory Diseases: Notable include treatment of hereditary angioedema
Women’s Health: First new treatment for endometriosis pain, first vaginal ring contraceptive for use for an entire year
Cancer and Blood Disorders: New advances for breast cancer, prostate cancer, lung cancer, melanoma, cancer in pancreas or gastrointestinal tract, first treatment for pheochromocytoma or paraganglioma, new cancer therapy to treat any tumor with specific genetic marker, acute myeloid leukemia, classical Hodgkin lymphoma, acute lymphoblastic leukemia, mycosis fungoides or Sézary syndrome, thrombocytopenia
Other: Non-opioid drug product for opioid withdrawal symptoms, non-opioid nerve block therapy, ulcerative colitis, neurotrophic keratitis, seven new biosimilars
CDRH-Record Year for Device Innovation
New Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention
Goal
