IDE Regulations

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Regulations pertaining to the Investigational Device Exemptions (IDE) are:

• 21 CFR 812 - Investigational Device Exemptions
• 21 CFR 50 - Protection of Human Subjects
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 54 - Financial Disclosure by Clinical Investigators
• 21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies
• 21 CFR 820 - Quality System Regulation

21 CFR 812 - Investigational Device Exemptions

An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under 812.30 or considered approved under 812.2(b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and regulations issued thereunder:

• Misbranding under section 502 of the act
• registration, listing, and premarket notification under section 510
• performance standards under section 514
• premarket approval under section 515
• a banned device regulation under section 516
• records and reports under section 519
• restricted device requirements under section 520(e)
• good manufacturing practice requirements under section 520(f) except for the requirements found in 820.30, if applicable (unless the sponsor states an intention to comply with these requirements under 812.20(b)(3) or 812.140(b)(4)(v)) and color additive requirements under section 721.

21 CFR 50 - Protection of Human Subjects

It applies to all clinical investigations regulated by the FDA under sections 505(i) and 520(g) of the Federal FD &C Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. It covers the following sections:

• Subpart A--General Provisions
• § 50.1 - Scope.
• § 50.3 - Definitions.
• Subpart B--Informed Consent of Human Subjects
• § 50.20 - General requirements for informed consent.
• § 50.23 - Exception from general requirements.
• § 50.24 - Exception from informed consent requirements for emergency research.
• § 50.25 - Elements of informed consent.
• § 50.27 - Documentation of informed consent.
• Subpart C [Reserved]
• Subpart D--Additional Safeguards for Children in Clinical Investigations
• § 50.50 - IRB duties.
• § 50.51 - Clinical investigations not involving greater than minimal risk.
• § 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
• § 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
• § 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
• § 50.55 - Requirements for permission by parents or guardians and for assent by children.
• § 50.56 - Wards.

21 CFR 56 - Institutional Review Boards

This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) and is divided into following sections:

• Subpart A--General Provisions
• § 56.101 - Scope.
• § 56.102 - Definitions.
• § 56.103 - Circumstances in which IRB review is required.
• § 56.104 - Exemptions from IRB requirement.
• § 56.105 - Waiver of IRB requirement.
• Subpart B--Organization and Personnel
• § 56.106 - Registration.
• § 56.107 - IRB membership.
• Subpart C--IRB Functions and Operations
• § 56.108 - IRB functions and operations.
• § 56.109 - IRB review of research.
• § 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
• § 56.111 - Criteria for IRB approval of research.
• § 56.112 - Review by institution.
• § 56.113 - Suspension or termination of IRB approval of research.
• § 56.114 - Cooperative research.
• Subpart D--Records and Reports
• § 56.115 - IRB records.
• Subpart E--Administrative Actions for Noncompliance
• § 56.120 - Lesser administrative actions.
• § 56.121 - Disqualification of an IRB or an institution.
• § 56.122 - Public disclosure of information regarding revocation.
• § 56.123 - Reinstatement of an IRB or an institution.
• § 56.124 - Actions alternative or additional to disqualification.

21 CFR 54 - Financial Disclosure by Clinical Investigators

The FDA reviews data generated in the clinical studies to determine whether the applications are approvable under the statutory requirements. FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study.

This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies.

21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies

This section prescribes good laboratory practices (GLP) for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal FD&C Act and sections 351 and 354-360F of the Public Health Service Act.

21 CFR 820 - Quality System Regulation

The current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the FD&C Act. This part establishes basic requirements applicable to manufacturers of finished medical devices.

Source:

www.fda.gov

Related Training:

Investigational Device Exemption - Purpose and Preparation