Safety and Efficacy study for a medical device in US

J

Jennifer27

#1
HI Experts,

I work with a small company which makes a non significant risk medical device. They are planning to do a small safety and efficacy study in US. Do they need to get at least IRB approval? or since its a small study with a very low risk device, they can do the study without any approval from FDA or IRB. Please suggest?

Thanks!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
HI Experts,

I work with a small company which makes a non significant risk medical device. They are planning to do a small safety and efficacy study in US. Do they need to get at least IRB approval? or since its a small study with a very low risk device, they can do the study without any approval from FDA or IRB. Please suggest?

Thanks!
Hi,

This is a bit too vague.

What does it mean "non significant risk"? Who made that determination? Based on what?

What is a "small" study? What does it involve?

In general, for clinical use involving human patients in the USA, the device needs either a cleared 510(k) or an IDE, or be duly classified as exempt.

Cheers,
Ronen.
 
J

Jennifer27

#3
Thank you Ronen. The determination was made based on FDA guidance document. The device is already cleared for use in females and the study is for use in males.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Exemptions from IDE regulations:

PART 812 -- INVESTIGATIONAL DEVICE EXEMPTIONS

Subpart A--General Provisions

Sec. 812.2 Applicability.

(a)General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.

(...)

(c)Exempted investigations. This part, with the exception of 812.119, does not apply to investigations of the following categories of devices:

(1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.

(2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.

(3) A diagnostic device, if the sponsor complies with applicable requirements in 809.10(c) and if the testing:

(i) Is noninvasive,

(ii) Does not require an invasive sampling procedure that presents significant risk,

(iii) Does not by design or intention introduce energy into a subject, and

(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

(4) A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.

(5) A device intended solely for veterinary use.

(6) A device shipped solely for research on or with laboratory animals and labeled in accordance with 812.5(c).

(7) A custom device as defined in 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

(d)Limit on certain exemptions. In the case of class II or class III device described in paragraph (c)(1) or (2) of this section, this part applies beginning on the date stipulated in an FDA regulation or order that calls for the submission of premarket approval applications for an unapproved class III device, or establishes a performance standard for a class II device.
If the Sponsor believes that the subject device is not a Significant Risk Device, they are still required to get approval from an IRB:

Sec. 812.2 Applicability.

(b)Abbreviated requirements. The following categories of investigations are considered to have approved applications for IDE's, unless FDA has notified a sponsor under 812.20(a) that approval of an application is required:

(1) An investigation of a device other than a significant risk device, if the device is not a banned device and the sponsor:

(i) Labels the device in accordance with 812.5;

(ii) Obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval;

(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator's care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 56.109(c).

(iv) Complies with the requirements of 812.46 with respect to monitoring investigations;

(v) Maintains the records required under 812.140(b) (4) and (5) and makes the reports required under 812.150(b) (1) through (3) and (5) through (10);

(vi) Ensures that participating investigators maintain the records required by 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and

(vii) Complies with the prohibitions in 812.7 against promotion and other practices.

(2) An investigation of a device other than one subject to paragraph (e) of this section, if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981.
(Emphasis added)

Non Significant Risk decisions are formally and finally made by the FDA or an IRB:

C. Who Decides Whether A Device Study is SR or NSR?

Sponsors are responsible for making the initial risk determination and presenting it to the IRB.
FDA is also available to help the sponsor, clinical investigator, and IRB in making the risk
determination.[2]

Unless FDA has already made a risk determination for the study, the IRB must review the
sponsor's SR or NSR determination for every investigational medical device study reviewed and
modify the determination if the IRB disagrees with the sponsor. If FDA has already made the
SR or NSR determination for the study, the agency's determination is final. FDA is available to
help the IRB when making its risk determination. (Also, see section VII. “How does an IRB
document the SR or NSR determination?”)

FDA is the final arbiter as to whether a device study is SR or NSR and makes the determination
when an IDE is submitted to FDA or if asked by the sponsor, clinical investigator, or IRB. See
21 CFR ? 812.2(b)(1)
______
[2] See the guidance entitled, “Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices.” This guidance may be found at: www.fda.gov/MedicalDevices/DeviceRegulatonandGuidance/GuidanceDocuments/ucm126598.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
 
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