21 U.S.C. § 360j — General provisions respecting control of devices intended for human use

(a) General rule Any requirement created under section 351, 352, 360, or 360i for a device made for human use keeps applying to that device until it is changed by action taken under section 360c, 360d, or 360e, or under subsection (g) of this section. If a requirement from those first sections conflicts with a requirement placed on the device under section 360d, 360e, or subsection (g), the older requirement stops applying to that device. (b) Custom devices (1) The requirements of sections 360d and 360e do not apply to a device that meets all of these conditions: (A) it is created or changed to follow the order of an individual physician, dentist, or another specially qualified person the Secretary has designated by regulation after an oral hearing; (B) following that order forces the device to depart from an otherwise-applicable performance standard under section 360d or requirement under section 360e; (C) it is not generally sold in finished form in the United States through the manufacturer's, importer's, or distributor's labeling or advertising; (D) it is designed to treat a unique medical condition that no other device available in the United States treats; (E) it is intended either (i) for the special needs of that physician, dentist, or qualified person in their professional practice, or (ii) for an individual patient named in the order; (F) it is assembled from parts, or manufactured and finished, case by case, to meet the unique needs described in (E); and (G) it may still share common, standardized design features, materials, and manufacturing processes with commercially sold devices. (2) This exemption applies to a device only if (A) the device is meant to treat a condition rare enough that clinical studies would be impractical; (B) no more than 5 units of that device type are made per year under this exemption; and (C) the manufacturer notifies the Secretary once a year, in the way the Secretary prescribes, that it made the device. (3) By 2 years after July 9, 2012, the Secretary had to issue final guidance on making multiple copies of devices as described in (2)(B). (c) Trade secrets Information the Secretary or a representative gets under section 360c, 360d, 360e, 360f, 360h, 360i, or 374, or under subsection (f) or (g) of this section, that is exempt from public disclosure under the Freedom of Information Act's trade-secret exception (5 U.S.C. 552(a), by reason of 552(b)(4)) must be treated as confidential. The Secretary may not disclose it, and may not use it as the basis for moving a device from Class III down to Class II or Class I, or for setting or changing a performance standard under section 360d for a device moved from Class III to Class II — except (1) as allowed under subsection (h), and (2) that it may be shared with other officers or employees carrying out this chapter, or used in a legal proceeding under this chapter other than one under section 360c or 360d. (d) Notices and findings Every notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i, or under this section — plus any other Federal Register notice describing an action taken under one of those sections and stating the reasons for it, and any required published findings tied to such rulemaking — must state: (1) how interested people may examine the data and other information the notice or findings are based on, and (2) how long people have to comment, orally or in writing, including on whether comment is even needed — at least 60 days and no more than 90, unless the Secretary extends it in a Federal Register notice stating a good reason. (e) Restricted devices (1) The Secretary may, by regulation, limit a device's sale, distribution, or use to (A) only with the written or oral authorization of a practitioner licensed to administer or use it, or (B) other conditions the Secretary prescribes — if the device's potential for harm, or the extra steps needed to use it, mean there is no other way to reasonably assure its safety and effectiveness. A condition under (B) may not limit use to people with specific training or experience, or to certain facilities, unless the Secretary decides that restriction is needed for safe and effective use. No condition may exclude someone from using a device just because they lack the training to be certified by a medical specialty board recognized by the American Board of Medical Specialties, or are not certified by one. A device under such a regulation is called a "restricted device." (2) The label of a restricted device must carry the statements about its restrictions that the Secretary requires in the regulation. (f) Good manufacturing practice requirements (1)(A) The Secretary may make regulations requiring that the methods, facilities, and controls used to manufacture a device, validate its pre-production design (assessing how it performs, not evaluating its safety or effectiveness), pack it, store it, and install it, follow "current good manufacturing practice," in order to assure the device is safe, effective, and otherwise follows this chapter. (B) Before issuing such a regulation, the Secretary must (i) give the advisory committee described in (3) a chance to recommend changes, (ii) hold an oral hearing, and (iii) make sure the regulation matches internationally recognized quality-system standards for medical devices, as much as is practical. The Secretary must give the committee reasonable time to respond. (2)(A) Anyone subject to a requirement made under (1) may petition the Secretary for an exemption or variance from it. The petition must (i) for an exemption, explain why compliance is not needed to assure the device is safe, effective, and otherwise compliant; (ii) for a variance, describe the alternative methods, facilities, and controls proposed; and (iii) include anything else the Secretary requires. (B) The Secretary may send the petition to the advisory committee, which must report its recommendation within 60 days of referral. Within 60 days after the petition was filed — or, if it was referred to the committee, after the committee's 60-day window ends, whichever is later — the Secretary must approve or deny the petition by order. (C) The Secretary may approve (i) an exemption, if compliance is not needed to assure the device is safe, effective, and otherwise compliant, or (ii) a variance, if the proposed alternative methods, facilities, and controls are good enough to assure that. An order approving a variance must set the conditions the device must follow to be safe, effective, and compliant. (D) After the Secretary issues an order on a petition, the petitioner may ask for an informal hearing on it. (3) The Secretary must set up a 9-member advisory committee to advise on proposed regulations under (1)(A) and on petitions under (2): 3 members from state, local, or federal government; 2 representing device manufacturing industry interests; 2 representing physicians and other health professionals; and 2 representing the general public. Non-federal members are paid, up to the daily rate of a GS-18 federal employee, for each day (including travel time) they work, plus travel expenses under standard federal rules for intermittent government service. The Secretary picks the committee's chair and gives it clerical and other help. A federal law that limits how long advisory committees may exist (5 U.S.C. 1013) does not apply to this one. (g) Exemption for devices for investigational use (1) This subsection exists to encourage the discovery and development of useful devices for human use, and to give researchers maximum freedom to pursue that goal, while still protecting public health, safety, and ethical standards. (2)(A) Within 120 days of May 28, 1976, the Secretary had to issue, by regulation, procedures and conditions letting a device get, on application, an exemption from the requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e, or subsection (e) or (f), or any combination of them, so qualified experts could investigate its safety and effectiveness. (B) These conditions must include (i) a requirement that an application be submitted to the Secretary, in the form and manner the Secretary specifies, before an exemption is granted; (ii) a requirement that the applicant keep records and report safety or effectiveness data from the investigation to the Secretary, so the Secretary can check compliance, review progress, and evaluate the device; and (iii) any other requirements the Secretary decides are needed to protect public health and safety. (C) These procedures and conditions may vary depending on (i) how large and long the clinical testing is; (ii) how many human subjects are involved; (iii) how much the device may need to change during testing under the plan required by (3)(A); and (iv) whether the testing is meant to support commercial approval. (3) As a condition of exempting a device that will be tested on human subjects, the applicant must (A) submit a plan for the proposed clinical testing, plus a report of prior investigations (including, where relevant, animal tests) good enough to justify that testing — to either the institutional review committee overseeing testing at the facility involved, or to the Secretary if no such committee exists or the Secretary finds its review inadequate — and, unless the full plan and report go to the Secretary, at least submit a summary of them; (B) promptly tell the Secretary when a review committee approves a submitted testing plan; (C) for a device given to multiple investigators for testing, get signed agreements from each investigator that testing will be under their supervision and follow (D), and send those agreements to the Secretary; and (D) make sure informed consent is obtained from each human subject or their representative — except, under conditions the Secretary may set, (i) when the testing poses no more than minimal risk and includes proper safeguards, or (ii) when the investigator determines in writing that a life-threatening emergency makes the device necessary and there is no time to get consent from the subject or their representative. That emergency determination must be confirmed by a licensed physician not involved in the subject's testing, unless there is no time even for that because the device is needed to save the subject's life. (4)(A) An application for a device exemption, other than an exemption from section 360f, is treated as approved on the 30th day after it is submitted, unless the Secretary disapproves it in writing, by order, before then. (B) The Secretary may disapprove an application only if the investigation does not follow the procedures and conditions set under (2). The disapproval notice must include the order and a full statement of reasons, and must offer the applicant an informal hearing. (C) Consistent with (1), the Secretary may not disapprove an application just because (i) the investigation might not support a finding of substantial equivalence, a de novo classification, or approval; (ii) it might not meet a requirement, including a data requirement, for approval or clearance; or (iii) more or different testing might later be needed. (5) The Secretary may withdraw an exemption if its conditions are no longer being met, generally only after an informal hearing — but may act before offering that hearing if continuing the testing would create an unreasonable risk to public health. (6)(A) Within 1 year of November 21, 1997, the Secretary had to set rules letting a device under an exemption make, without a new exemption approval or supplement, (i) design or manufacturing changes that are not a significant change in design or in how the device basically works, made in response to what is learned during the investigation, and (ii) protocol changes that do not affect (I) the validity of data already gathered under an approved protocol, or the risk-to-benefit relationship the protocol was approved on, (II) the scientific soundness of a plan submitted under (3)(A), or (III) the rights, safety, or welfare of the human subjects. (B) These changes are allowed if (i) the study's sponsor decides, based on credible information as the Secretary defines it, that the (A) conditions are met, and (ii) the sponsor tells the Secretary about the change within 5 days of making it. (7)(A) For someone planning to test the safety or effectiveness of a Class III or implantable device, the Secretary must give them a chance, before they file a full application, to submit an investigational plan (including a clinical protocol) for review. If they submit a written meeting request, the Secretary must meet with them within 30 days to try to agree on the plan. That request must include a detailed description of the device, its proposed conditions of use, a proposed plan for showing reasonable assurance of effectiveness, and any available performance data. (B) Any agreement reached on the plan must be put in writing and added to the record. It may not be changed except (i) with the sponsor's or applicant's written agreement, or (ii) if the director of the review office decides, following (C), that a substantial scientific issue essential to the device's safety or effectiveness has come up. (C) That director's decision must be in writing, and may only be made after the sponsor or applicant has had a chance to meet with the director and discuss the scientific issue. (8)(A) The Secretary may, at any time, stop a sponsor from running an investigation — called a "clinical hold" — if a determination described in (B) is made, and must state the specific basis for the hold in writing. (B) That determination is either (i) that the device poses an unreasonable safety risk to the subjects, considering the investigators' qualifications, information about the device, the study's design, the condition being studied, and the subjects' health, or (ii) another reason the Secretary sets by regulation. (C) A written request to lift a clinical hold must get a written decision, with reasons, within 30 days of the request — the request must include enough information to support lifting the hold. (9)(A)(i) A sponsor whose device requires an investigational device exemption application must submit, as part of that application, a "diversity action plan" for the device's clinical studies, in the form the Secretary specifies. (ii) A sponsor whose device does not require that exemption application — except for certain devices studied under 21 CFR 812.2(c) — must still develop a diversity action plan for any clinical study of the device, and submit it with any premarket notification, classification request, or premarket approval application for that device. (B) A diversity action plan must include (i) the sponsor's enrollment goals for the study, (ii) the reasoning behind those goals, and (iii) how the sponsor plans to meet them. (C)(i) The Secretary, on the Secretary's own initiative or at a sponsor's request, may waive a diversity action plan requirement if a waiver is needed based on how common the disease or condition is, if following a plan would otherwise be impractical, or if the waiver is needed to protect public health in an emergency. (ii) The Secretary must grant or deny a sponsor's waiver request in writing within 60 days of receiving it. (D) No diversity action plan is required for a submission described in section 360bbb. (h) Release of information respecting safety and effectiveness (1) The Secretary must make regulations requiring a detailed public summary of the safety and effectiveness information that was the basis for (A) an order approving or denying a premarket approval application, or withdrawing an approval; (B) an order revoking an approved protocol, declaring a protocol complete or not complete, or revoking a device's approval; or (C) an order granting, denying, or withdrawing an investigational exemption under subsection (g) from section 360f. These summaries must be released once the related order is issued, and must include information about any adverse health effects of the device. (2) The Secretary must make regulations requiring each advisory committee formed under section 360e(g)(2)(B) to release a public summary of the safety and effectiveness information behind its recommendation to the Secretary. That summary can only be released after the related order is issued, and must include information about any adverse health effects of the device. (3) Except as (4) allows, information released under (1) or (2) (A) may not be used by anyone other than the original submitter to establish another device's safety or effectiveness, and (B) must still be released subject to the confidentiality rule in subsection (c). (4)(A) Subject to (C), information in a premarket approval application filed under section 360e(c) — including clinical and preclinical test data showing a device's safety and effectiveness, but not manufacturing methods, product formula descriptions, or other trade secrets — becomes available for the Secretary's use, 6 years after the application is approved, for (i) approving another device, (ii) deciding whether a product development protocol is complete for another device, (iii) setting a performance standard or special control, or (iv) classifying or reclassifying another device under section 360c and subsection (l)(2). (B) The public summaries required by (1)(A) may also be used as evidence for those same actions. (C) Information in a premarket approval application may not be used to approve or clear an application under section 360e or 360(k), or to classify a product under section 360c(f)(2), for a combination product that includes an approved drug (as defined in section 353(g)(5)(B)), unless (i) the application includes the certification or statement required by section 353(g)(5)(A), (ii) the applicant gives the notice required by that same section, and (iii) the Secretary's approval follows the rules in section 353(g)(5)(C). (i) Proceedings of advisory panels and committees Every panel under section 360c, and every advisory committee formed under section 360d(b)(5)(B) or 360e(g) or under subsection (f) of this section, must make and keep a transcript of its proceedings. Each panel and committee must remove from that transcript any information that subsection (c) says must be kept confidential. (j) Traceability Except as allowed under section 360i(e) (device tracking), no regulation under this chapter may require a type or class of device to be traceable unless that requirement is necessary to protect public health. (k) Research and development The Secretary may enter into contracts for research, testing, and demonstrations involving devices, and may obtain devices for research, testing, and demonstration purposes, without following certain federal procurement rules (title 31, section 3324(a) and (b), and title 41, section 6101). (l) Transitional provisions for devices considered as new drugs (1) A device made for human use that, as of May 28, 1976 (called the "enactment date"), fell into one of these categories is placed in Class III, unless the Secretary reclassifies it into Class I or II in response to a petition under (2): (A) it had an approved application under section 355(b) in effect; (B) such an application had been filed but no approval or refusal order had been issued yet; (C) it had an investigational exemption under section 355(i) in effect; (D) it is the same type as a device under (A), (B), or (C), and is substantially equivalent to it; (E) the Secretary had, before the enactment date, published a Federal Register notice declaring it a "new drug" subject to section 355; or (F) a court case was pending on the enactment date under section 332, 333, or 334, alleging a violation of section 331 tied to section 355's requirements, or alleging a violation of section 355(a). (2) The Secretary may start reclassifying a device placed in Class III under (1), or the manufacturer or importer may petition for an order reclassifying it into Class I or II. Within 30 days of the petition being filed, the Secretary must tell the petitioner about any deficiencies preventing a decision. Except as (3)(D)(ii) allows, within 180 days of the petition being filed, the Secretary must, after consulting the relevant advisory panel under section 360c, either deny the petition or order the reclassification into Class I or II, using the criteria in section 360c(a)(1)(A) or (B). (3)(A) A device described in (1)(A) that is in Class III (i) is treated, as of the enactment date, as a device with an approved application under section 360e, and (ii) keeps following the requirements it had under section 355 before the enactment date, until the Secretary changes them as this chapter allows. (B) For a device described in (1)(B) that is in Class III, its application is treated as filed under section 360e on the enactment date. The Secretary's period to act on it under section 360e(d)(1) is 180 days from the enactment date (or longer, if the Secretary and applicant agree after the required finding), minus however many days the application had already been pending under section 355. After that period ends, the device needs an approved application under section 360e, unless it is exempt under subsection (g). (C) A device described in (1)(C) that is in Class III is treated as a "new drug" until 90 days after subsection (g) regulations are issued. After that, the device needs an approved application under section 360e, unless exempt under (g). (D)(i) Except as (ii) and (iii) allow, a device described in (1)(D), (E), or (F) that is in Class III must, starting 60 days after the enactment date, have an approved application under section 360e, unless it is exempt under subsection (g). (ii) If a reclassification petition under (2), or a premarket approval application, is filed for such a device within that 60-day period (or a longer period the Secretary and the petitioner or applicant agree to), the Secretary must act on it within 120 days of filing, and clause (i)'s requirement does not apply to the device until that 120-day period ends, or until the petition or application is denied, whichever comes first. (iii) For a device described in (1)(E) that the Secretary, after March 31, 1976, declared a "new drug" subject to section 355, and that is in Class III: (I) the device must have an approved application under section 360e 18 months after the enactment date, unless exempt under subsection (g); and (II) between 180 days and 18 months after the enactment date, the Secretary may limit the device's use to investigational use by qualified experts, following the same rules that apply to investigational devices exempted under subsection (g) — and if those rules are applied, they must be applied so the device stays reasonably available to physicians who meet the Secretary's qualifications. (4) Repealed by Congress on November 21, 1997 (Pub. L. 105–115, title I, § 125(b)(2)(E)). (5)(A) Before December 1, 1991, the Secretary had to order manufacturers of devices described in (1) that were subject to reclassification under (B) to submit a summary of, and citation to, everything they knew about the devices — including adverse safety or effectiveness information not already reported under section 360i. The Secretary could also require the manufacturer to submit the underlying data behind that summary, if the manufacturer had it. (B) Except as (C) allows, after that order but before December 1, 1992, the Secretary had to publish a regulation in the Federal Register for each Class III device described in (1), either reclassifying it into Class I or II, or keeping it in Class III, applying the criteria in section 360c(a). Before publishing a regulation that keeps a device in Class III or reclassifies it, the Secretary had to publish a proposed regulation and take public comments. Such a regulation could not take effect until at least 90 days after the proposed regulation was published. (C) The Secretary could, by notice in the Federal Register, extend the (B) deadline for a device by up to 1 additional year. (m) Humanitarian device exemption (1) This subsection exists to encourage the discovery and use of devices that help patients with diseases or conditions affecting no more than 8,000 people in the United States, while protecting public health, safety, and ethical standards. (2) The Secretary may grant an exemption from the effectiveness requirements of sections 360d and 360e for a device the Secretary finds (A) is designed to treat or diagnose a disease or condition affecting no more than 8,000 people in the United States, (B) would not be available to patients with that condition without this exemption, and has no comparable device available outside the exemption, and (C) will not expose patients to unreasonable or significant risk, where its likely health benefit outweighs the risk, compared with currently available devices or treatments. The request must be an application to the Secretary, including the certification required under 42 U.S.C. 282(j)(5)(B) (which does not itself count as part of the application). The Secretary must approve or deny the application within 75 days of receiving it. (3) Except as (6) allows, no one granted this exemption may sell the device for more than the cost of researching, developing, making, and distributing it. (4) A device with this exemption may only be used (A) at facilities where an institutional review committee, set up under the Secretary's regulations, supervises clinical testing of devices, and (B) after that committee, or an appropriate local committee, approves its use for the specific disease or condition — unless a physician determines in an emergency that getting that approval in time would risk serious harm or death to the patient. In that emergency situation, the physician must, after using the device, notify the committee's chairperson, including the patient's identity, the date the device was used, and the reason for using it. (5) The Secretary may require someone with this exemption to show they are still complying with its requirements, if the Secretary believes that is needed to protect public health, or has reason to believe the (6) conditions or the exemption's criteria are no longer met. If they fail to show continued compliance, the Secretary may suspend or withdraw the exemption — but only after giving notice and a chance for an informal hearing. (6)(A) Except as (D) allows, the price limit in (3) does not apply to someone with this exemption if all of these are true: (i) the device either (I) treats or diagnoses a disease or condition that occurs in pediatric patients or a pediatric subpopulation, and is labeled for use in that pediatric group, or (II) treats or diagnoses a disease or condition that either does not occur in pediatric patients, or occurs in so few of them that developing the device for them is impossible, highly impractical, or unsafe; (ii) in any calendar year, the number of devices distributed under the exemption does not exceed the "annual distribution number" — the number of devices reasonably needed to treat, diagnose, or cure 8,000 people in the United States, which the Secretary sets when granting the exemption; (iii) the person immediately tells the Secretary if that number is exceeded in a year; and (iv) the exemption request was submitted by October 1, 2027. (B) The Secretary may inspect the records of someone using this price exception, showing how many devices were distributed in a calendar year. (C) A person may petition the Secretary to change the annual distribution number for a device if new information comes up, and the Secretary may agree to change it. (D) If a person reports, or the Secretary finds through an inspection, that the number of devices distributed in a year went over the annual distribution number required by (A)(iii) (as modified under (C), if applicable), the price limit in (3) starts applying again to that device's sales by that person after the notification. (E)(i) "Pediatric patients" means patients who are 21 or younger at the time of diagnosis or treatment. (ii) "Pediatric subpopulation" means one of: neonates, infants, children, or adolescents. (7) The Secretary must send any adverse event report about a device described in (6)(A)(i)(I) whose price limit does not apply, to the Office of Pediatric Therapeutics. That office's Director, working with device experts at the Center for Devices and Radiological Health, must have the Pediatric Advisory Committee periodically review the report, including getting the committee's recommendations on whether the Secretary should act in response to it. (8) The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, must have the Pediatric Advisory Committee review every device described in (6)(A)(i)(I) each year, to check that the exemption still fits the pediatric populations it was granted for. (n) Regulation of contact lenses as devices (1) All contact lenses are treated as "devices" under section 321(h). (2) This does not affect, or say anything about, whether any product other than a contact lens is a "device" under section 321(h) or a "drug" under section 321(g). (o) Regulation of medical and certain decision support software (1) The term "device," as defined in section 321(h), does not include a software function meant only for: (A) administrative support of a health care facility — including processing and keeping financial records, claims or billing information, appointment schedules, business analytics, patient population information, admissions, practice and inventory management, using historical claims data to predict future use or cost, deciding health benefit eligibility, population health management, and laboratory workflow; (B) maintaining or encouraging a healthy lifestyle, unrelated to diagnosing, curing, easing, preventing, or treating a disease or condition; (C) serving as electronic patient records — including patient-provided information — to the extent the records transfer, store, convert the format of, or display the same content as a paper medical chart, as long as (i) health care professionals, or people working under their supervision, created, stored, transferred, or reviewed the records; (ii) the records are part of health information technology certified under 42 U.S.C. 300jj–11(c)(5); and (iii) the function is not meant to interpret or analyze the records, including medical images, to diagnose, cure, ease, prevent, or treat a disease or condition; (D) transferring, storing, converting the format of, or displaying clinical laboratory test or other device data and results, a health care professional's findings on that data, general information about those findings, or general background about the test or device — unless the function is meant to interpret or analyze the data, results, or findings; or (E) unless the function is meant to gather, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system — for (i) displaying, analyzing, or printing medical information about a patient or other medical information, such as peer-reviewed clinical studies and clinical practice guidelines; (ii) supporting or recommending prevention, diagnosis, or treatment decisions to a health care professional; and (iii) letting that professional independently review the basis for the recommendation, so that the professional is not meant to rely mainly on the software to make a diagnosis or treatment decision for a patient. (2) For a product with multiple functions, where at least one software function meets the criteria in (1), or otherwise does not meet the definition of "device" under section 321(h), and at least one other function does not meet (1) and does meet the "device" definition, the Secretary will not regulate the (1)-type function as a device. But when judging the safety and effectiveness of the function or functions that are a device, the Secretary may still consider the effect the non-device software function has on them. (3)(A) Despite (1), a software function described in (C), (D), or (E) of (1) is still counted as a "device" if (i) the Secretary finds that using it would likely have serious adverse health consequences, and (ii) the function has been named in a final order the Secretary issues under (B). (B) (A) applies only if the Secretary (i) publishes a notification and proposed order in the Federal Register, (ii) includes in it the Secretary's finding under (A)(i), with the reasoning and evidence behind it, and (iii) allows at least 30 days for public comment before issuing a final order or withdrawing the proposed one. (C) In making a finding under (A)(i) about a software function, the Secretary must consider (i) how likely and severe patient harm would be if the function did not work as intended; (ii) how much the function is meant to support a health care professional's own judgment; (iii) whether a health care professional has a real chance to review the basis for the information or treatment recommendation the function gives; and (iv) who is meant to use the function and in what setting, including whether a health care professional will use a function of the type described in (1)(E). (4) Nothing in this subsection limits the Secretary's power to (A) use enforcement discretion for any device regulated under this chapter, (B) regulate software used in making and transfusing blood and blood components to help prevent disease in people, or (C) regulate software as a device under this chapter if it meets the criteria in section 360c(a)(1)(C). (p) Diagnostic imaging devices intended for use with contrast agents (1) The Secretary may, subject to the rest of this subsection, approve a premarket approval application or supplement filed under section 360e for an "applicable medical imaging device," make a substantial equivalence determination for one filed under section 360(k), or grant a request filed under section 360c(f)(2), even if it involves using a contrast agent in a way not on the agent's approved label — as long as that use is not (A) at a different concentration, administration rate, or route of administration than the label describes, unless the Secretary finds the difference does not hurt the contrast agent's safety and effectiveness when used with the device; (B) in a different body region, organ, or system than the label describes, with the same kind of safety-based exception; (C) in a different patient population than the label describes, again with that exception; or (D) using a different imaging method (modality) than the label describes — with no exception listed for this one. (2) The part of the agency that reviews devices before they reach the market has primary authority over these applications, notifications, and requests, and may (A) consult with the part of the agency that reviews drugs or biological products before market, and (B) review information and data the contrast agent's sponsor gave the Secretary in its own drug application, as long as that sponsor has given the device's sponsor a right to reference it, and the device application follows this subsection's rules. (3) An application, notification, or request described in (1) must follow the requirements of whichever section it is filed under (360e, 360(k), or 360c(f)(2)), and is otherwise only subject to this chapter's device requirements. (4) For purposes of this subsection: (A) "applicable medical imaging device" means a device meant to be used with a contrast agent, or class of contrast agents, for an imaging use not described in that agent's approved label (or the label of any contrast agent in the same class); and (B) "contrast agent" means a drug approved under section 355 or licensed under 42 U.S.C. 262, meant for use with an applicable medical imaging device, that is either (i) a "diagnostic radiopharmaceutical" as defined in specific FDA regulations (21 CFR 315.2 and 601.31, or any successor rules), or (ii) a diagnostic agent that improves how well a structure, function, tissue, or fluid shows up by increasing the signal difference between it and its surroundings. (q) Regulation of over-the-counter hearing aids (1)(A) An "over-the-counter hearing aid" is a device that (i) uses the same basic scientific technology as air conduction hearing aids or wireless air conduction hearing aids, as those are defined in FDA regulations; (ii) is meant for adults 18 and older to make up for mild to moderate hearing loss they perceive; (iii) lets the user, through tools, tests, or software, control and adjust it to their own hearing needs; (iv) may use wireless technology, or include tests for self-checking hearing loss; and (v) is sold over-the-counter — without the supervision, prescription, or other involvement of a licensed person — to consumers in person, by mail, or online. (B) This term does not include a personal sound amplification product meant to boost sound for people without hearing loss, in situations like hunting or bird-watching. (2) An over-the-counter hearing aid is regulated under the rules issued under section 709(b) of the FDA Reauthorization Act of 2017, and is exempt from two specific FDA regulations, 21 CFR 801.420 and 801.421 (or any successor rules).