FDA / Regulatory News
7 FDA Pathways to bring Medical Device to US Market:
- Premarket Notification 510(K) – most common route to launch a medical device. Almost all Class II devices and certain Class I devices will require a 510(k). The purpose of a 510(k) submission is to provide the FDA with documented evidence showing that your medical device is substantially equivalent in terms of safety and effectiveness to a predicate device.
- Premarket Approval (PMA) – Class III devices, and any device that cannot provide substantial equivalence to a Class I or Class II device through the 510(k) process, must use the Premarket Approval (PMA) pathway. The PMA process is the most involved as scientific evidence, typically in the form of a clinical trial, is needed to prove the safety and effectiveness of your device.
- De Novo – If a company developing a lower risk, “novel” device and is struggling to find a predicate, the De Novo pathway might be the best option. Companies that do not qualify for 510(k) clearance, due to the fact that they cannot provide substantial equivalence to a device on the market can use De Novo pathway
- Humanitarian Device Exemption (HDE) – pathway is for devices that are intended to treat or diagnose conditions or diseases that affect small or rare populations. For HDE pathway there cannot be another comparable device on the market that shares the same intended use. Part of the rationale for providing this pathway is there may not be a large enough patient population with clinical data to satisfy regular FDA requirements of safety and efficacy.
- Custom Device Exemption (CDE) – pathway for a custom device for a specific patient. The product should be specifically designed totreat a unique pathology or physiological condition that no other device is domestically available to treat. It must be assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of the patient.
- Expanded Access Program (EAP) – often referred to as the compassionate use or emergency use provision. It allows aninvestigational device to be used, outside of a clinical trial, in situations where a seriously ill patient has few if any alternatives.
- Product Development Protocol (PDP) – subset of the PMA process that allows for another pathway for companies with devices in which the technology is well established in the industry. This pathway allows the company to come to an early agreement with the FDA about how safety and effectiveness of the device will be shown. The two parties are essentially creating a contract that describes design and development activities, including the outputs of these activities, and acceptance criteria for these outputs.
FDA Warning Letter, Posted March 3, 2020
Company Name – Silfradent Srl (Italy, manufacturer of instruments for dental laboratories)
Subject: CGMP/QSR/Medical Devices/Adulterated
Violations included in the letter:
- Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). The DHF does not include design inputs, design outputs, design reviews, design verifications, design validations, and design transfers.
- Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s Client Claims Management Procedure does not include requirements for investigating complaints involving the possible failure of a device, labeling, and packaging to meet any of its specifications and evaluating complaints for MDR reportability
- Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
Product Recalls and Issues
Alaris System Infusion Pumps Class I Recall
Alaris System Infusion Pumps by Becton Dickinson (BD) CareFusion 303 – Class I Recall
For modules with software version 9.33 or earlier, the following issues apply:
- Software/System errors (System Error 255-xx-xxx)
- Delay options programming
- Low battery alarm failures
- Keep vein open (KVO) / “End of Infusion” alarm priority
- Use-related errors related to custom concentration programming
For modules with software version 12.1.0, the following issues apply:
- Low battery alarm failures
- Keep vein open (KVO)/ “End of Infusion” alarm priority
- Use errors related to custom concentration programming
- KVO Rate Not Available When Using Delay Options programming
These errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).
There have been serious adverse health events with each of these errors. There are 55 reported injuries and one death.