Regulation of Investigational Medical Devices:

are concerned that loopholes in the current regulations for medical devices, thomas novelli, us market: 2008 priorities, med. device tech., may/june 2008, at 58, 58, efficacy before insurance companies will reimburse could prevent some patients 42 administration (fda) has determined that the regulations for class i and class ii id. fda.33 categories: class i, class ii, and class iii.3 to disclosure in investigational research, especially when financial incentives are available at http://www.fda.gov/cdrh/devadvice/ide/print/ideall.pdf [hereinafter cdrh device 21 c.f.r. � 812.36(a) (2008). annals of health law requirements for additional evidence of device efficacy before there is little disagreement regarding the need for rigorous clinical trials id. also discusses safeguards to minimize public exposure to harmful devices and 12 another exception to the formal approval process, in which investigational 60 typically, compassionate-use patients are similar to emergency-use before they are approved for public use. these provisions are set up to ensure that continue to be an ongoing challenge for research investigators.56 kendell l. coker, ph.d.* stringent clinical trials are the best solution.63 28 depending on the classification, the device is 15 2 10 66 high risk investigational devices fda, irb guidance, supra note 2. ide allows the investigators to conduct the clinical trials necessary to gather data veracity of sponsor-related research data.42 may cause an injury, but investigators are only required to report device 62 advice]. 36 140 annals internal med. 296, 296-297 (2004) (describing different classifications of medical typically, in the case of an ide guidance]; see also 21 c.f.r. � 812.35(a)(2) (2008) (discussing studies involving class iii consumers to report adverse events.44 benefits and obstacles these three classifications include stethoscopes, computer tomography scanners, volume 18 fall 2008 pages 29-37 klepinski, supra note 24, at 851; see 21 c.f.r. � 812.35(a) (2008). satisfactory alternative device or other therapy is available."15 __________________________________________________________________ treatments, programs like medicare and medicaid exclude such treatments from although the use of investigational devices in such situations can create however, the compassionate-use patients do not meet preset 23 time frames of clinical trials, there are delays in delivering these products to 56 the irb governs research studies at institutions to ensure 24 in response, other practitioners argue that these medical congress to reevaluate medical device regulation, 17 health matrix 441, 446-447 (2007) payment rule-issuing agencies, such as the centers for medicare and medicaid to evaluate device malfunctions and irregularities.45 novelli, supra note 58, at 58. whatever the final solution becomes, it should be driven by the best interest of the patient will benefit from the device's use in the treatment of his or her disease or 32 annals of health law advance directive [vol. 18 2008] cdrh device advice, supra note 12, at 1. 13 michael j. schneck, critical appraisal of medical devices in the management of an id. see generally vanburen, supra note 7, at 441-446. on the safety and effectiveness of the device to support market approval.16 __________________________________________________________________ 17 33 annals of health law advance directive [vol. 18 2008] malfunctioning medical devices.43 21 c.f.r. � 812.35(a)(2); see irb medical devices, supra note 17, at 9. where the device is necessary to "save the life of a patient...suffering from a id. at 515-16. see generally 21 u.s.c. � 360(d) (2006). report deaths and serious injuries within ten working days from the time the 11 __________________________________________________________________ treatments may be expensive, and thus requiring a higher standard of clinical effectiveness and/ or safety of the device."2 however, some practitioners advocate id. � 812.36(a) investigational devices used in clinical studies is to require investigators to report devices]. id. id. at 11. id. � 812.1(a). 1 (discussing approval standards based on device classification). id. at 441. class iii devices are subject to more stringent fda regulations and safeguards events may be underreported.39 see id. rainville, supra note 34, at 10-11. if clinical investigators chose to conduct a in some cases, these devices in certain situations, investigational devices may be used on a patient who see henderson & smith, supra note 50, at 517. vi. reimbursement obstacles the medical device reporting (mdr) provisions require investigators to and ensuring patient safety prior to formal approval of investigational devices.64 64 focus on death and mortality factors.55 id. 53 40 21 u.s.c. � 360(c)(a)(1). condition.27 situations which warrant exceptions to the use of investigational medical devices some defines institutions as any public or private entity where the research is being conducted). committee, or other group formally designated by an institution to review, to approve the initiation 48 therefore, william h. maisel, medical device regulation: an introduction for the practicing physician, 610 (2005) (discussing exclusion of "experimental" treatment from insurance coverage). investigational medical devices and discussing the history device regulation). see klepinski, supra note 24, at 853. 31 annals of health law advance directive [vol. 18 2008] drug l.j. 849, 851 (2007). patients who need them.51 measuring methods in investigational research). mark barnes & jerald korn, medicare reimbursement for clinical trial services: fda exercises their aforementioned regulatory authority to minimize the even after the product is finally approved and delivered to public consumers, the trials that are consistent with fda standards for safety and effectiveness will regulation of investigational medical devices 21 u.s.c. � 360(d)(a)(1) (2006). however, due to the lengthy and costly 14 despite the limitations in regulating investigational medical devices, there 7 allowing reimbursement may leave patients paying expensive medical bills for a id. at 10-11. 54 38 for failure to comply with reporting requirements.49 unapproved device can not be used on human subjects until it is cleared for use in caused or contributed to a serious injury or death, must report the incident to the devices 9 (2006), http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf [hereinafter irb medical before formal approval, along with justification for these exceptions. this article this seems to be where the agreement ends. some commentators urge that stricter 37 the fda allows the use of investigational devices for such emergencies without see schneck, supra note 53, at 19; see also henderson & smith, supra note 50, at 517. 19 __________________________________________________________________ regulation of investigational medical devices 41 5 regulatory discretion to grant a protocol deviation to treat the patient.29 unforeseen risks to patients, and are deviations from investigational protocols, the involved.40 medical devices are split into three investigational devices that are considered high risk are not exempted 22 specifically regulations (or loopholes) that create a public health risk are flawed ii. standard research and approval procedures for 33 reimbursement unless it has been proven efficacious.57 an investigator, who has reason to believe that an investigational device to research participants. if the study involves a "significant risk device," both the medical devices are safe and effective.8 57 see id. id. and increase a patient's risk for injury or death.10 generally inadmissible in civil actions against private parties, the entities' officials 35 annals of health law advance directive [vol. 18 2008] is not a subject in the clinical trial. one exception includes emergency situations finding a uniform solution does reimbursement obstacles potential of harm to patients. furthermore, the fda offers guidance to 21 c.f.r. � 803(1)(a) (2005). investigational medical devices.30 consequently, concerns have been raised about the id. � 56.104(c). devices). cerebrovascular disease, 4 therapeutics & clinical risk mgmt. 19, 19 (2008); henderson & likelihood that harm will occur and are subject to a process of scientific and * iv. mandatory reporting id. at 516. 9 30 background and legal basis, 60 food & drug l.j. 511, 515 (2005) (arguing for new clinical trial devices are inadequate to ensure the safety of these class iii devices.7 47 i. introduction serious disease or condition for which there exists no other alternative therapy."20 see irb medical devices, supra note 17, at 1. is a proper standard.65 51 therefore, adverse investigate and report adverse events that are "reasonably known" to them.35 not appear likely in the near future, despite efforts toward such progress. adverse events received each year by the fda.37 clinical trials with an ide.17 maisel, supra note 4, at 299. increasing implications for ischemic stroke, 36 stroke 398, 399 (2005). __________________________________________________________________ prior to public use of medical devices.50 unapproved, and potentially harmful, devices.62 unfortunately, there is an additional factor which leads to underreporting 49 this article discusses research protocol, regulatory procedure, and 46 id. treatment. even when the fda authorizes investigators to use experimental 50 regulation of investigational medical devices: treatment necessary to save their lives.60 35 class iii devices have the highest accessing new treatments being studied in clinical trials or that are commercially once an ide is granted, the investigators need to see klepinski, supra note 24, at 853 (discussing the compassionate use provision). 59 is made available to the public, it must undergo rigorous testing to comply with 29 18 and clinical investigators can be subject to substantial fines and prison sentences that clinical efficacy focuses more specifically on the effectiveness of the device 39 devices may be used on subjects not in a clinical trial, is termed "compassionate 36 annals of health law advance directive [vol. 18 2008] 37 annals of health law advance directive [vol. 18 2008] competitive advantage.41 use."24 michael vanburen, closing the loopholes in the regulation of medical devices: the need for investigator becomes aware of the incident.34 available."59 malfunctions that actually cause serious injury or death.38 the investigator must also notify the irb within five unlike emergency use, compassionate use requires prior fda procedures 17 (1998) available at http://www.fda.gov/cdrh/ode/idepolcy.pdf [hereinafter cdrh maisel, supra note 4, at 299. as an additional safeguard to maximize reporting of adverse events, the vii. conclusion threatening disease or condition in patients for whom no comparable or overall, care while concurrently providing quality data on the effectiveness of good clinical practice program, fda, information sheet guidance for irb's, 6 process for class iii devices raises public health concerns.9 can keep patients from receiving life-saving medical device treatment even after from receiving beneficial medical treatment.66 office of comm'r, fda, guidance for institutional review boards and clinical gay parks rainville, when a biomedical device fails: navigating the regulatory and legal seems to be consensus regarding their benefit to the public good. unfortunately, available at http://www.devicelink.com/mdt/archive/08/05/010.html. 32 subsequent noncompliance could result in civil (and possibly criminal) however, health care professionals 25 fda standards.12 63 both compassionate and emergency uses allow patients the benefit of innovative investigations."18 potential risk is generally not life-threatening.6 but the treating physician believes the __________________________________________________________________ investigators are only required to see jennifer a. henderson & john j. smith, realizing the potential for biomarkers in imaging: see ctr. for devices and radiological health (cdrh), fda, device advice 1 (2003), regulation of investigational medical devices investigational medical devices.1 61 of, and to conduct periodical review of, biomedical research involving human subjects" and 34 annals of health law advance directive [vol. 18 2008] maisel, supra note 4, at 299. purpose is to "protect the rights and welfare of human subjects involved in such see id. regulation of investigational medical devices some commentators fda, irb guidance]; see generally richard a. merrill, regulation of drugs and devices: an investigators, as well as to irbs, to avoid confusion and maximize compliance.31 21 c.f.r. � 812.35(a)(2) (2008). treatment.25 statutory provisions are in place to regulate the performance standards of v. clinical trials: a solution or a problem? inclusionary criteria for the clinical trials,26 regulatory review, known as premarket approval, because the food and drug patients and public health, not private interests or financial incentives. ide, the device is under clinical investigation "for a serious or immediately life- public.5 mortality data and greater focus on clinical efficacy.54 cdrh device advice, supra note 12, at 1. device which is the subject of a clinical study designed to evaluate the 30 annals of health law advance directive [vol. 18 2008] obtain approval from their respective institutional review board (irb) whose robert j. klepinski, access to clinical devices through nontraditional routes, 62 food & of injuries caused by malfunctioning devices. conflicts of interest create barriers one part of the approval process is clinical investigation for that insurance companies should not provide full reimbursement until the device 27 regulation of investigational medical devices whereas class ii devices present the potential for such a risk, although the 319 sci. 1340,1342 (2008) (discussing intellectual-property issues and data accuracy). in the treatments of the specific disease, as opposed to the current standards that clinical investigation, they must obtain an investigational device exemption (ide) 29 nonetheless, some groups criticize these regulations because the approval iii. exceptions and deviations from standard protocol class i devices pose no potential for unreasonable risk of illness or injury, medical devices). __________________________________________________________________ injuries.36 use to the fda within five working days from the time the principal clinical researchers and practitioners propose that there should be less emphasis on although reports filed in accordance with mdr requirements are from the pre-market approval process.11 before a high risk investigational device evolution, 13 health affairs 47, 55-58 (1994) (providing background information about advance directive anthony j. furlan & marc fisher, devices, drugs, and the food and drug administration: an investigational medical device is "a medical manufacturers are concerned that disclosures may undermine their 21 u.s.c. � 360(c)(a)(1) (2006). others believe that more because these are subject to varying levels of regulatory scrutiny before being marketed to the device manufacturers report a majority of the 80,000 to 120,000 obstacles to insurance coverage. medical studies, the principal clinical investigators are usually physicians. an requirements.46 id. see generally deborah a. zarin & tony tse, moving towards transparency of clinical trials, consequently, the problems inherent in the design of some clinical trials increase patient mortality.52 vanburen, supra note 7, at 441. id. at 298. adverse events.32 the current standards of clinical fda regulations would better serve the public by minimizing the use of investigators 1998 update (1998), http://www.fda.gov/oc/ohrt/irbs/devices.html [hereinafter 26 45 regulation of investigational medical devices generally, the fda will initially issue a warning letter.47 the fda also takes an active role in the see maisel, supra note 4, at 296-297. 16 law. 8 services (cms), to "create barriers that discourage medicare beneficiaries from investigators must also provide to the fda an annual report of deaths and serious barnes & korn, supra note 57, at 610; see also furlan & fisher, supra note 61, at 399. and pacemakers, respectively.4 fda has implemented penalties for failure to comply with reporting 4 58 as discussed, there are drawbacks 21 however, the investigator must report and justify the emergency regulation of investigational medical devices 43 device companies do not want demonstrates unequivocal clinical efficacy.61 juris doctor candidate, loyola university chicago school of law, class of 2010. nova compliance with research protocols, and is designed to minimize the risk of harm 55 investigator learns of it.22 cdrh ide guidance, supra note 20, at 19. 21 c.f.r. � 56.101(a) (2008); see also 21 c.f.r. � 56.102(f)(g) (defines irb as "any board __________________________________________________________________ trials typically focus on factors, such as design safety and mortality, are quite id. at 299. 3 examples of devices that fall into working days.23 and patients can also report to the fda suspected injuries that result from exist to maintain a balance between providing patients with life-saving treatment 34 20 44 penalties.48 52 regulation of investigational medical devices irb and the fda must approve the ide.19 smith, supra note 50, at 516. devices cause serious injury or harm). clinical investigators, and sponsors: frequently asked questions about medical the device has been cleared for public use.58 next question becomes: who pays for it? insurance companies may not want to ctr. for devices and radiological health, fda, guidance on ide policies and understanding medicare coverage in establishing a clinical trial budget, 38 j. health l. 609, id. process by sending trained investigators to conduct routine field inspections, and southeastern university, ph.d., class of 2006. dr. coker is a staff member of annals of health thus, the fda is reliant upon physicians and costly because they can be lengthy and require patient tracking.53 31 in addition to the delays in the clinical trial process, insurance coverage is rainville, supra note 34, at 10. landscape, intell. prop. & tech. l.j., feb. 2007, at 10 (discussing required procedure when one strategy the fda employs to monitor the risks associated with establishing rigorous and efficient clinical prior approval.21 approval.28 __________________________________________________________________ another obstacle that prevents the use of investigational or experimental testing on human participants.13 from the fda before starting the investigation.14 to both potential solutions. the emergency and compassionate use exceptions id. patients in that they have a serious disease or condition and there is no alternative under the compassionate use exception, the fda utilizes its 65 these researchers argue pay unless they are convinced of the efficacy, and some practitioners believe this