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 Department of Health and Human Services Food and Drug Administration 21 CFR Part 884
[Docket No. FDA-2011-N-0118]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Final rule.
 SUMMARY: The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.
 DATES: This rule is effective May 16, 2011. The classification was applicable on January 13, 2011.
 FOR FURTHER INFORMATION CONTACT: Glenn Bell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G112, Silver Spring, MD 20993-0002, 301-796-6531.


SUPPLEMENTARY INFORMATION:  I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act (21 U.S.C.360c(i)), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA will, within 60 days of receiving this request, classify the device by written order. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the 
                    **Federal Register**
                     announcing this classification. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on August 5, 2009, classifying the Hem-Avert Perianal Stabilizer into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On August 17, 2009, Plexus Biomedical, Inc., submitted a petition requesting classification of the Hem-Avert Perianal Stabilizer under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II. (Ref. 1) In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device. The device is assigned the generic name hemorrhoid prevention pressure wedge, and it is identified as a hemorrhoid prevention pressure wedge that provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth. FDA has identified the following risks to health associated specifically with this type of device and the recommended measures to mitigate these risks. Table 1—Health Risks and Mitigations
Identified risk
Mitigation measuresSkin/tissue trauma (
                            *e.g.,*
                             rectal and/or anal trauma, necrosis, thinning, abrasion, laceration to the perineum, vulvar hematoma, sloughing)
Nonclinical Analysis and Testing.
                             Clinical Information. 
                             Labeling.Device failure (
                            *e.g.,*
                             material failure, slippage)
Nonclinical Analysis and Testing.
                             Labeling.Device failure—obstruction to the treatment area caused by inability to remove the instrument quickly
Device Description.
                             Labeling.Infection.
Labeling.Adverse tissue reaction
Biocompatibility.Pain
Nonclinical Analysis and Testing.
                             Biocompatibility.
 FDA believes that the following special controls address the risks to health and provide reasonable assurance of the safety and effectiveness of the device: (1) The sale, distribution, and use of this device are restricted to 
                    ( print page 21238)
                    prescription use in accordance with 21 CFR 801.109; (2) the labeling should include specific instructions regarding the proper placement and use of the device; (3) the device should be demonstrated to be biocompatible; (4) mechanical bench testing of material strength should demonstrate that the device will withstand forces encountered during use; and (5) safety and effectiveness data should demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls. Therefore, on January 13, 2011 (corrected order sent to petitioner on February 1, 2011), FDA issued an order to the petitioner classifying the device into class II. FDA is codifying the classification of the device by adding § 884.5200. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a hemorrhoid prevention pressure wedge will need to address the issues covered in the special controls. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the hemorrhoid prevention pressure wedge they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of this device from class III to class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. (21 U.S.C. 360k); 
                    *See Medtronic*
                     v. 
                    *Lohr,*
                     518 U.S. 470 (1996); 
                    *Riegel*
                     v. 
                    *Medtronic, Inc.,*
                     552 U.S. 312 (2008). The special controls established by this final rule create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility in how they meet these requirements. Cf. 
                    *Papike*
                     v. 
                    *Tambrands, Inc.,*
                     107 F.3d 737, 740-42 (9th Cir. 1997). V. Paperwork Reduction Act of 1995 This final rule establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 32501-3520). The collections of information in part 807, regarding premarket notification submissions, have been approved under OMB control no. 0910-0120; the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control no. 0910-0485. VI. References The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from Plexus Biomedical, Inc., August 17, 2009. List of Subjects in 21 CFR Part 884 Medical devices
 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows: PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
 1.The authority citation for 21 CFR part 884 continues to read as follows: Authority:
                        21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2.Section 884.5200 is added to subpart F to read as follows: § 884.5200
  (a) 
                            *Identification.*
                             A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth. (b) 
                            *Classification.*
                             Class II (special controls). The special controls for this device are:
                            ( print page 21239) (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions regarding the proper placement and use of the device. (3) The device must be demonstrated to be biocompatible. (4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use. (5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.
 Dated: April 11, 2011. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget.


[FR Doc. 2011-9141 Filed 4-14-11; 8:45 am] BILLING CODE 4160-01-P