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U.S. Department of Health and Human Services

Medical Devices

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Required Submission of Safety and Effectiveness Information for Certain Class III Devices

Introduction

On April 9, 2009, FDA published an Order in the Federal Register requiring manufacturers of twenty-five (25) Class III preamendments devices to submit to FDA a summary of, and citation to, any known, or otherwise available, safety or efficacy information, including that information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i). See (74 FR 16214). The twenty-five (25) devices identified are those Class III preamendment devices for which a final regulation requiring the submission of a PMA has yet to be issued. See section 501(f)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351).

What device types are affected by this Order?

All manufacturers currently marketing the preamendments class III devices identified in the chart below must provide a summary of, and citation to, any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act.

The April 9, 2009, Order applies to all manufacturers of the device types listed below.

DEVICE TYPE CLASSIFICATION
REGULATION
(21 CFR XXX.XXX)
CORRESPONDING
PRODUCT CODE(s)
Membrane lung for long-term pulmonary support 868.5610 BYS
Intra-aortic balloon and control system 870.3535 DSP, NKO
Ventricular bypass (assist) device 870.3545 OKR
External pacemaker pulse generator 870.3600 DTE
Implantable pacemaker pulse generator 870.3610 DSZ, DXY
Endosseous dental implant (blade-form) 872.3640(b)(2) NRQ
Cardiovascular permanent pacemaker electrode 870.3680(b) DTB
Pacemaker programmers 870.3700 KRG
Pacemaker repair or replacement material 870.3710 KFJ
Mandibular condyle prosthesis
(for temporary reconstruction)
872.3960(c)(2) NEI
Nonroller-type cardiopulmonary bypass blood pump 870.4360 KFM
External cardiac compressor 870.5200 LIX, DRM
External counter-pulsating device 870.5225 DRN
Automated external defibrillator 870.5310 NPN, NSA, MKJ
Implanted blood access device 876.5540(b)(1) NIF, MSD, NYU
FJM, FJN, FJO
FJQ, LTH, FIQ
NNF, FKN, FKW
KNR, KNZ, LBW, LFJ
Sorbent hemoperfusion system 876.5870 FLD
 Cranial electrotherapy stimulator 882.5800 JXK
Electroconvulsive therapy device 882.5940 GXC
Female condom 884.5330 OBY
Pedicle screw spinal system (certain uses) 888.3070(b)(2) NKB
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis 888.3320 JDL, LTO
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis 888.3330 KWA
Shortwave diathermy (certain uses) 890.5290(b) ILX
Iontophoresis device (certain uses) 890.5525(b) EGJ
Transilluminator for breast evaluation 892.1990 LEK

What should a required submission include?

A manufacturer of a device listed in the above table must submit the information detailed here. The format of this submission depends upon whether the manufacturer is aware of information that would support the reclassification of the device into class I (general controls) or class II (special controls). Information that would support the reclassification of the device must consist of adequate, valid scientific evidence showing that general controls alone, or general controls along with special controls, will provide a reasonable assurance of the safety and effectiveness of the device.

If a manufacturer is not aware of adequate and valid scientific information that would support the reclassification of its device into class I or class II, or the manufacturer is aware of adequate and valid scientific information that would support leaving the device as a Class III device, the information should be submitted in the following format:

1. Indications for use.

A general description of the disease or condition to be diagnosed, treated, cured, mitigated, or prevented, including a description of the patient population for which the device is intended.

2. Device description.

An explanation of how the device functions, significant physical and performance characteristics of the device, and basic scientific concepts that form the basis for the device.

3. Other device labeling.

Other device labeling that includes contraindications, warnings and precautions and/or promotional materials.

4. Risks.

A summary of all adverse safety and effectiveness information and identification of the risks presented by the device as well as any mechanisms or procedures which will control the risk.

5. Alternative practices and procedures.

A description of alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended.

6. Summary of preclinical and clinical data.

The summary of preclinical and clinical data should include the conclusions drawn from the studies that support the safety and effectiveness of the device, and that address the adverse effects of the device on health.

The summary should include a brief description of the objective of the studies, the experimental design, how the data were collected and analyzed, and a brief description of the results of the studies, whether positive, negative, or inconclusive.

The summary of the clinical study should also include a discussion of the subject inclusion and exclusion criteria, the study population, reasons for patient discontinuations, and results of statistical analyses.

7. Bibliography.

A copy of each key reference, a brief summary of the salient features of each key reference, and a brief discussion of why the reference is relevant to an evaluation of the safety and effectiveness of the device.

If a manufacturer is aware of adequate and valid scientific information that would support the reclassification of the device into class I or class II, the manufacturer may either submit information using the format described below or submit a formal reclassification petition, as described in 21 CFR 860.123(a)(3)-(4), should include:

1. Identification.

A brief narrative identification of the device. This identification should be specific enough to distinguish a particular device from a generic type of device.
Where appropriate, this identification should include a listing of the materials, and the component parts, and a description of the intended use of the device.

2. Risks to health.

An identification of the risks to health. This section should summarize all adverse safety and effectiveness information that has not been submitted under section 519 of the act, particularly the most significant information. The mechanisms or procedures that will control the risk should be described.

A list of the general hazards associated with the device and a bibliography with copies of the referenced material should be provided.

3. Recommendation.

A statement whether the manufacturer believes the device should be reclassified into class I or class II.

4. Summary of reasons for recommendation.

Each manufacturer should include a summary of the reasons for requesting reclassification of its device and an explanation of why it believes the device meets the statutory criteria for reclassification into class I or class II.

Each manufacturer should also identify the special controls that it believes would be sufficient to provide reasonable assurance of the safety and effectiveness of its device if it believes the device should be reclassified into class II.

5. Summary of valid scientific evidence on which the recommendation is based.

Manufacturers are advised that, when considering a formal reclassification petition, FDA will rely only upon valid scientific evidence to determine whether there is reasonable assurance of the safety and effectiveness of the device, if regulated by general controls alone (class I) or by general controls and special controls (class II).

Valid scientific evidence consists of evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. . Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. (See 21 CFR 860.7(c)(2)).

The amount and degree of evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use.

How do I submit the required information?

The summary of, and citation to, any information required by the Order must be submitted by August 7, 2009 to the Division of Dockets Management. Submit hard copies of summaries and citations to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic copies of summaries and citations to http://www.regulations.gov. Identify summaries and citations with the docket number FDA-2009-M-0101.

For additional information, contact Sarah K. Morabito, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3975.