The determination of whether or not a device clinical trial is required is largely based upon a FDA classification of the device, as illustrated in the table below:
- Reusable Scalpel
- Elastic bandage
- Infusion Pump
- Powered wheelchair
- Implantable pacemaker
- IVD test for cancer
|Requires a clinical trial?
||Maybe(less than 10 percent of the 510(k) submissions)
FDA may request clinical performance data (clinical trials) to support a substantial equivalence (SE) determination if:
- New or Modified Indications for Use – Same Intended Use (For example: the new device is an IVD that is indicated for over-the-counter use, whereas the predicate device is indicated for prescription use in the home or prescription use in a clinical setting.)
- Technological Differences (For example: some devices that display data about the patient’s anatomy or physiology, e.g., glucose meters, pulse oximeters, blood pressure cuffs, are supported by software. If there is a change in the software that relates to how the software analyzes the patient’s anatomy or physiology, the device may need to be tested on actual patients to assure that the software performs in a manner that is equivalent to the previous version. In this case, non-clinical data may not suffice.)
- Non-clinical Testing Methods are Limited or Inappropriate Because of the Indications for Use or Device Technology (For example: the non-clinical performance testing on the new device may be insufficient to support a substantial equivalence determination if the testing cannot replicate the way the device will be used or the way similar devices have been demonstrated to fail in a clinical setting)
In the U.S., clinical studies/investigations involving one or more human subjects to determine the safety or effectiveness of a device must be conducted in accordance with the Investigational Device Exemptions (IDE) regulations, 21 CFR Part 812, as applicable.
This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations (e.g. clinical trials). This guidance supplements the guidance for industry on Part 11, Electronic Records; Electronic Signature. The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA.
This guidance provides the following recommendations regarding the use of computerized systems in clinical investigations:
- Study Protocols – Each specific study protocol should identify each step at which a computerized system will be used to create, modify, maintain, archive, retrieve, or transmit source data.
- Standard Operating Procedures – There should be specific procedures and controls in place when using computerized systems to create, modify, maintain, or transmit electronic records, including when collecting source data at clinical trial sites.
- Source Documentation and Retention – Under 21 CFR 312.62, 511.1(b)(7)(ii) and 812.140, the clinical investigator must retain records required to be maintained under part 312, § 511.1(b), and part 812, for a period of time specified in these regulations.
- Internal Security Safeguards – Limited access for authorized individuals, audit trails, date/time stamps
- External Security Safeguards – External safeguards should be put in place to ensure that access to the computerized system and to the data is restricted to authorized personnel.
- Other System Features:
- Direct Entry of Data – incorporate prompts, flags, or other help features into your computerized system to encourage consistent use of clinical terminology and to alert the user to data that are out of acceptable range.
- Retrieving Data – the computerized system should be designed in such a way that retrieved data regarding each individual subject in a study is attributable to that subject
- Dependability System Documentation – for each study, documentation should identify what software and hardware will be used to create, modify, maintain, archive, retrieve, or transmit clinical data.
- System Controls – when electronic formats are the only ones used to create and preserve electronic records, sufficient backup and recovery procedures should be designed to protect against data loss. Records should regularly be backed up in a procedure that would prevent a catastrophic loss and ensure the quality and integrity of the data. Records should be stored at a secure location specified in the SOP.
- Change Controls – The integrity of the data and the integrity of the protocols should be maintained when making changes to the computerized system, such as software upgrades, including security and performance patches, equipment, or component replacement, or new instrumentation. The effects of any changes to the system should be evaluated and some should be validated depending on risk. Changes that exceed previously established operational limits or design specifications should be validated. Finally, all changes to the system should be documented.
Training of Personnel – Those who use computerized systems must determine that individuals (e.g., employees, contractors) who develop, maintain, or use computerized systems have the education, training and experience necessary to perform their assigned tasks (21 CFR 11.10(i)).
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Smiths Medical (Headquarters: Minneapolis, MN) is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Use of the affected syringe pumps may cause serious adverse health consequences including death.