Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-D-1528]</DEPDOC> <SUBJECT>Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers.” This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. This draft guidance is not final nor is it for implementation at this time. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the draft guidance by August 4, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on any guidance at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2024-D-1528 for “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03"> https:// </E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353; or Phillip Kurs, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is announcing the availability of a draft document entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers.” This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. An owner or operator of an establishment who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is generally required to register the establishment and submit listing information for all devices in commercial distribution. <SU>1</SU> <FTREF/> Under section 510(k) of the FD&C Act, each person who is required to register their establishment must generally submit a 510(k) to FDA at least 90 days before proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use if the device is being introduced into commercial distribution for the first time. <SU>2</SU> <FTREF/> When a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM), an internet-based registration and listing system, if engaged in activities requiring listing. <SU>3</SU> <FTREF/> When listing, if the device is not significantly changed or modified, <SU>4</SU> <FTREF/> the new 510(k) holder must supply the original FDA-assigned premarket submission number  <SU>5</SU> <FTREF/> unless submitting a new 510(k), in which case the new 510(k) holder would supply the new FDA-assigned premarket submission number. <SU>6</SU> <FTREF/> The new 510(k) holder must, if not previously entered into an operation described in 21 CFR 807.20(a), register within 30 days after entering into such an operation and submit device listing information, including the FDA-assigned submission number, <SU>7</SU> <FTREF/> at that time. <SU>8</SU> <FTREF/> A device manufactured, prepared, propagated, compounded, or processed in an establishment that is not duly registered under section 510, or a device that is not included in a list required by section 510(j), is misbranded. <SU>9</SU> <FTREF/> <FTNT> <SU>1</SU>  21 CFR 807.20(a); see FD&C Act subsections 510(b), 510(i), and 510(j). Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States is required to register and list in conformance with the procedures in 21 CFR 807.40, 21 CFR 807.41, and subpart B of 21 CFR part 807. The registration requirement does not apply to owners or operators that are exempt under section 510(g) of the FD&C Act or subpart D of 21 CFR part 807. </FTNT> <FTNT> <SU>2</SU>  21 CFR 807.81(a)(2); also see FD&C Act section 513(i). Note that a 510(k) is not required for a device for which a premarket approval application under section 515 of the FD&C Act, or for which a petition to reclassify under section 513(f)(2) of the FD&C Act, is pending before FDA, or there is a predetermined change control plan (PCCP) cleared under section 515C of the FD&C Act, provided that the change is consistent with the PCCP. 21 CFR 807.81(b)(1). </FTNT> <FTNT> <SU>3</SU>  21 CFR 807.25. </FTNT> <FTNT> <SU>4</SU>  For discussion about ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━