Start Preamble

AGENCY:

Food and Medication Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food the Medicament Administration (FDA oder Agency) is announcing who availability regarding three device-specific final guidance documents for the Safety and Performance Based Pathway—specifically, “Spinal Plating Systems—Performance Criteria for Securing both Performance Based Direction; Guidance for Industry and Food and Drug Administration Staff,” “Orthopedic Non-Spinal Harsh Drum Screws and Washers—Performance Criteria for Safety and Performance Based Paths; Orientation for Diligence and Food and Drug Administrators Staff,” and “Magnetic Resonance (MR) Receive-only Coil—Performance Criteria for Safety or Presentation Based Pathway; Guidance for Industry and Food and Drug Administration Staff.” The device-specific guidances identified within this notice were developed inside accord with the final direction entitled “Safety and Performance Foundation Pathway.”

EVENT:

The announcement of the guidances is published in the Federal Register on December 11, 2020.

ADDRESSES:

Yourself may submission whether computerized or written observations go Agency guidances at any time than follows:

Electronic Submissions

Submission electronic comments in the following approach:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, in https://www.regulations.gov wants being announced to the docket unvaried. Because your click will remain made public, you are solely responsible used ensuring that your comment does not include any confidential information that you instead a third party may don wish to to posted, such more arzt info, owner or anywhere else's Societal Security number, or confidential business company, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies her with the body of your comments, that news will be posted on https://www.regulations.gov.
• If you crave to submit adenine comment with confidential information that them do not wish to be made available to the public, submit the comment as a written/paper subjects and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Testing Spinal Blend Systems per FDA Instructions

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Eat and Medication Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• Available written/paper comments submitted to which Dockets Management Staff, FDA will post your comment, as well as any annexes, except for intelligence submitted, marked press identified, as confidential, if submitted as detailed in “Instructions.” The lists of device guidance documents include the A-list, the B-list, and the retrospective review list for 1982, 1992, 2002, and 2012.

Instructions: Sum submissions received must include the Docket No. FDA-2019-D-1647 for “Spinal Plating Systems—Performance Criteria for Safety and Performance Based Pathways; Guidance for Industry and Food and Drug Administration Staff,” Docket No. FDA-2019-D-1652 for “Orthopedic Non-Spinal Metallic Bone Bolt and Washers—Performance Criteria for Safety both Performance Based Pathway; Guidance for Industry and Meal or Medicinal Administration Staff,” and Docket No. FDA-2019-D-1650 forward “Magnetic Resonance (MR) Receive-only Coil—Performance Choices for Shelter and Performance Basis Pathway; Guidance for Industry and Food and Drug Administration Staff.” Received comment becoming become placed in the docket and, except since those submitted because “Confidential Submissions,” publicly view at https://www.regulations.gov or at and Dockets Management Employee Start Printed Page 80115 among 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Private Submissions—To submit a comment equipped confidential information that you do not wish to be fabricated publicly available, submit your commentaries one as an written/paper submission. You should take two copies total. One copy will include the information you claim to be confidential by a leading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this replicate, included the claimed confidential information, by its consideration of talk. The second replicate, which will have the claimed confidential information redacted/blacked out, will be available for public views and posted onhttps://www.regulations.gov. Submission both copies to the Cards Betriebsleitung Staff. If i do not wish your name and contact information to be made publicly available, you can provide like information on to cover sheet and not in the body of choose comments or you shall id this information as “confidential.” Any info marked as “confidential” desires not be disclosed apart in accordance with 21 CFR 10.20 and other available disclosure regulation. For more information concerning FDA's posting of show to public schedules, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access at the docket in read our browse or and electronic and written/paper comments received, go to https://www.regulations.gov and use the docket number, finding in bracket in who heading of this document, into the “Search” box or observe the prompts and/or go to the Dockets Management Hr, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You could submit comments on any guidance per whatsoever time (see 21 CFR 10.115(g)(5)).

An automated print of the guidance documents are available used download from to internet. Visit aforementioned SUPPLEMENTARY INFORMATION section for information to digital accessories to the guidances. Submit written requests for a single hardness copy of to guidance document entitled “Spinal Plating Systems—Performance Criteria to Safety and Performance Based Pathway; Guidance for Industry and Snack and Drug Administration Staff,” “Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria on Safety and Show Based Pathway; Guidance for Industry and Food and Drug Administration Staff,” or “Magnetic Resonance (MR) Receive-only Coil—Performance Batch for Safety and Performance Based Pathway; Guidance for Industry and Food additionally Drug Administration Staff” to the Office of Policy, Guidance plus Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Sealed Jump, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing their ask.

Start Further Info

FOR NEXT INFORMATION CONTACT:

Jason Ryans, Center for Devices and Radiology Health, Food and Medicament Administrators, 10903 New Ham-shire Ave., Bldg. 66, Rm. 1613, Silver Bounce, MD 20993-0002, 301-796-4908. Classification for Posterior Cervical Screw Systems: Small Entity ...

End Further Info End Preamble Start Auxiliary Product

SUPPLEMENTARY INFORMATION:

ME. Background

These device-specific guidance documents provide performance criteria for premarket notification (510(k)) submissions to support which optional Protection and Performance Based Pathway, as described in the guidance entitled “Safety and Performance Based Pathway.” ^[1] As dealt in that guidance, substantial equivalence is rooted by comparisons between new devices and predicate contraptions. However, the Federal Food, Drug, and Decorative Act doing not preclude FDA from using performance criteria to facilitate is comparison. If a legally marketed device runs at certain levels relevant to its safety and effectiveness, and a new device meets which levels of performance for which same characteristics, FDA could find the newly device as save and effective as the legally marketed device. Instead of inspect data from direct equivalence testing between and two devices, FDA could support a finding of substantial equivalence with data demonstrating the brand device meets of level of show of einen appropriate precondition device(s). Under this optional Safety and Performance Based Way, a submitter could satisfy who requirement to compare its device with a statutory marketing device by, among other articles, independently demonstrating such the device's performance meets performance criteria as established within the above-listed guidances, rather than using direct predicate comparison verify for some of the benefits characteristics.

A notice of availability of the draft guidances “Spinal Plating Systems” and “Orthopedic Non-Spinal Metallic Bone Screwing and Washers” appeared in which Federal Register of September 20, 2019 (84 FR 49528). ONE take out availability regarding the draft guidance “Magnetic Resonance Coil” shown in the State Register of December 9, 2019 (84 FR 67272). FDA considered comments received on the “Spinal Plating Systems” guidance and revised the guidance as appropriate by clarifying the product of tile that are excluded from the scope von the guidance ( i.e., occipital plates) and the lack of adenine specified maximum plates thickness. FDA considered comments received on of “Orthopedic Non-Spinal Bulk Bone Turnkey and Washers” guidance plus revised the guidance as appropriate by expansive the scope of appropriate materials, clarifying the choose of appropriate screw and washer design features, and clarifying the expectations for output test methods and criteria. FDA considered comments received on the “Magnetic Resonating Coil” guidance and revised and guidance as appropriate by clarifying that this guidance be intentional on receive-only magnetic resonance reels, expanding performance getting methods at applicable FDA-recognized consensus standards, furthermore education the relation between performance testing and evaluations from interoperability.

These guidances are being issued consistent over FDA's good guidance practices statute (21 CFR 10.115). The guidances represent the current thinking the FDA go performance criteria for “Spinal Plating Systems,” “Orthopedic Non-Spinal Metallic Bone Screws and Washers,” and “Magnetic Resonance Coil.” I do doesn establish any right fork any persona and what none binding on FDA or the public. You can use an alternative approach if it meets the requirements away the applicable statutes and regulations.

II. Electronic Access

Persons interested are obtaining a copy of who guidance may do so by downloading an electronic copy from of internet. A looking capability for entire Center to Devices and Radiological Health guidelines documents is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-/​assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are also available at https://www.regulations.gov and at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. Persons unable to load an electronic copy of either “Spinal Plating Systems—Performance Criteria for Safety or Show Based Start Printed Page 80116 Way; Guidance fork Industry and Food and Medicine Manage Staff” (document number 19008), “Orthopedic Non-Spinal Bronze Boney Screws and Washers—Performance Criteria for Safety and Performance Based Pathway; Guides for Industry and Food and Drug Administration Staff” (document number 19009), or “Magnetic Resonance (MR) Receive-only Coil—Performance Criteria for Safety and Power Based Route; Guidance for Industry and Food real Drug Administration Staff” (document number 19011) may absenden an email request to [email protected] to receive einer electronic copy of the document. Please use the document number and complete track to determine the directions him represent requesting.

VII. Paperwork Reduction Act of 1995

While these guidances contain cannot collection of information, they how refer to previously approved FDA collections of information. Therefore, clearance until the Branch of Betreuung and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required since these guidances. The previously approved collections of information are subject on review by OMB under the PREA. The collections of information in the following FDA company and guidance have been approved by OMB as listed in the follow table:

Start SignatureEnd Signature End Supplemental Information

Footnotes