On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability… [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]

FDA regulates medical devices based on risk and has established three general classifications: “class I” (general controls required to provide reasonable assurance of the safety and effectiveness of the device), “class II” (special controls required), or class III (premarket approval required). The regulatory framework for class III devices is especially stringent—FDA reviews class III device safety and effectiveness under a premarket approval (“PMA”) application that takes six months or more to approve, if the device is found suitable for marketing. The 510(k) “premarket notification” submission, however, enables lower-risk devices that are “substantially equivalent” to existing, legally marketed (“predicate”) devices not subject to a PMA to obtain marketing clearance without a PMA. Under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), new devices receiving not substantially equivalent (“NSE”) determinations are automatically designated a class III device. The de novo process serves as an alternative pathway for receiving marketing authorization for class I or II devices.

In the Proposed Rule, FDA seeks to clarify and formalize the de novo pathway for novel devices without predicates. Many of these proposals are contained in various recent guidances from FDA.[2] Below we break down key components of the Proposed Rule:

 

FDA Reviewing Procedures: Facility Inspections Proposed

Perhaps the most controversial component of the proposed de novo pathway is a provision that enables FDA to conduct premarket manufacturing inspections of “relevant facilities” as part of its de novo review process. Although these manufacturing inspections are authorized under the FDCA as an element of the PMA application review, the FDCA does not grant this authority to FDA for de novo review.[3] If this provision remains upon rule finalization, de novo requesters must have their quality systems prepared for inspection. Failing to permit an authorized FDA employee to inspect a relevant facility results in automatic “withdrawal” of the de novo request.

This provision may also be problematic in light of FDA’s proposed timeline for de novo request acceptance. The Proposed Rule requires FDA to grant or decline a de novo request within 120 days from when it receives the request or any additional information. While de novo request devices are required to be classified within the same timeframe under the FDCA, 120 days is rarely met. According to the Medical Device User Fee Amendments 2017 (“MDUFA IV”), FDA articulates that it aims to “issue a MDUFA decision within 150 FDA days of receipt of the submission for . . . 55% of de novo requests received in FY 2019.” (emphasis added). FDA’s self-stated goals appear to make the proposed 120-day codification lofty, especially considering FDA’s authorization and intention to make premarket manufacturing inspections during its de novo request reviews.

 

Notable De Novo Request Content Requirements

The Proposed Rule intends to clarify the minimum content requirements as prescribed in section 513(f)(2) of the FDCA. Most of these components are consistent with de novo guidance recommendations, but there are a handful of new proposed requirements:

  • Bibliography of “all published reports” and other unpublished “identification, discussion, and analysis of any other data, information, or report” relevant to the safety and effectiveness of the device. This practice is typically reserved to higher-risk PMA applications under 21 C.F.R. 814.20(b)(8).
  • Samples of the device and its components (if requested by FDA). This practice is typically reserved to higher-risk PMA applications under 21 C.F.R. 814.20(b)(9).
  • Proposed advertisements and labels for the device. Although not uncommon for companies to include sample labeling information in 510(k) notifications, this proposed provision would now make it a requirement in de novo requests, similar to PMA applications under 21 C.F.R. 814.20(b)(10).
  • Information about “known or reasonably known existing [device] alternative[s].”
  • Statement that provides (1) a list of any required information that is omitted in the de novo request and (2) “a justification” for any omissions.

 

Acceptance Review

FDA proposes an acceptance review stage for de novo submissions during which FDA makes a “threshold determination” as to whether the de novo request contains sufficient information to warrant substantive review. Within 15 days of receiving the de novo request or additional information, FDA must complete the acceptance review and notify the requester—after 15 days, the de novo request is automatically accepted for substantive review. The Proposed Rule identifies several “deficiencies” that warrant a refusal to accept (“RTA”), including: (1) incorrect de novo request format; (2) incomplete submission of required content; and (3) the failure to provide a “complete response” to FDA requests for additional information or deficiencies identified by FDA in any prior submissions for the same device. These deficiencies are similar to the Refuse to Accept Policy for 510(k)s guidance and “Acceptance Checklist[s]” issued by FDA in January 2018.

 

Confidentiality Provisions

FDA sets forth confidentiality provisions that are similar to other FDA marketing submissions. FDA must maintain confidentiality of the requester’s de novo application until it issues an order granting the request. FDA must also maintain confidentiality of all information provided in the request. Public disclosure by the requester, however, renders these confidentiality requirements inapplicable.

The preamble makes it clear that FDA is proposing this rule to bring greater structure, clarity, and efficiency to the de novo classification process. This rule essentially formalizes many of the criteria recommended in various FDA guidances and provides more certainty (albeit less flexibility) for both de novo requesters and FDA enforcement.

The Proposed Rule is available for public comment until March 7, 2019. If finalized, FDA the regulations would go into effect 90 days after the final rule is published.

 

[1] 83 Fed. Reg. 63,129 (Dec. 7, 2018).

[2] See, e.g., U.S. FDA, Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation) (Oct. 30, 2017), available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm080197.pdf; U.S. FDA, Draft Guidance: Acceptance Review for De Novo Classification Requests (Oct. 30, 2017), available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm582251.pdf.

[3] In fact, the FDCA expressly prohibits FDA from conducting these premarket facility inspections in its 510(k) review (“other than a finding that there is a substantial likelihood that the failure to comply with such regulations will potentially presents a serious risk to human health”). See FDCA Sec. 513(f)(5).

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to rely on predicates older than ten years and making public information about cleared devices that relied on predicates more than ten years old. In addition, the FDA intends to finalize guidance establishing an alternative 510(k) pathway with different criteria that reflect current technological principles.

In a statement, FDA Commissioner Scott Gottlieb reasoned that newer products relying upon older predicates might not reflect new performance standards or latest scientific and medical understanding. Commissioner Gottlieb believes this change will promote the continual improvement of medical devices. However, the announced change received quick pushback. Many manufacturers argue that reliance upon older predicates can be necessary when no newer predicates are available, and older predicates can provide data that helps sponsors make new devices safer. In addition, many industry-observers believe the FDA’s plans may contradict and exceed its statutory authority, and therefore require additional support from Congress.

If the current proposal becomes law, the implications will include increased costs for manufacturers forced to innovate because of the inability to rely on older predicates. The agency’s statement indicates that new medical devices that utilize the 510(k) pathway should be better than predicates, rather than the applicable legal standard of substantial equivalence. Thus, manufacturers can anticipate increased agency scrutiny when submitting information in the 510(k) summaries. In addition, manufacturers may need to make alternative plans if developing a new device based on an older predicate.

On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and that FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices. Although the OIG report “did not identify evidence that FDA mismanaged or responded untimely to a reported medical device cybersecurity event,” it noted that “existing policies and procedures did not include effective practices for responding to these events.”

Citing cybersecurity of medical devices as a top management challenge for HHS, OIG conducted an audit to evaluate FDA’s plans and processes for timely communicating and addressing cybersecurity compromises in the medical device postmarket phase. Based on OIG’s audit of certain FDA internal policies, procedures, and website, as well as interviews with FDA staff, OIG recommended that FDA take the following actions: (i) continually assess the cybersecurity risks to medical devices and update its plans and strategies; (ii) establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders; (iii) enter into a formal agreement with federal agency partners; and (iv) establish and maintain procedures for handling recalls of medical devices vulnerable to cybersecurity threats. Although the OIG acknowledged that FDA has recently implemented some of its initial recommendations, it emphasized that its findings and recommendations with regard to FDA’s cybersecurity policies and procedures remain valid.

On the same date OIG published its report, FDA’s Suzanne B. Schwartz, M.D., M.B.A., published a post on FDA Voices asserting that the OIG report is an incomplete and inaccurate picture of FDA’s oversight of medical device cybersecurity. The post addresses FDA’s ongoing efforts to improve medical device cybersecurity over the past five years, including entering into a memorandum of agreement between FDA and the Department of Homeland Security (“DHS”) and publishing a new premarket cybersecurity guidance update in October 2018, which we wrote about in a previous blog here. FDA’s post also highlights FDA’s other partnerships with industry that aim to increase awareness of cybersecurity vulnerabilities and related concerns.

FDA reiterated that its regulatory approach to cybersecurity threats “is not static,” and reconfirmed its commitment to “work with the medical device industry and other stakeholders to proactively address emerging cybersecurity threats to medical devices in a way that puts patient safety first.” FDA has announced that it will hold a public Workshop on January 29-30, 2019 to discuss the newly released draft guidance on cybersecurity in premarket submissions. Instructions for registration are available on FDA’s website here.

In response to the OIG’s report, FDA will likely continue to develop new cybersecurity policies, initiatives, and guidance. Stakeholders in the medical device industry should monitor these developments and be prepared to address any such changes in policy or regulation. Meanwhile, regulated industry should consider reviewing FDA’s current cybersecurity guidance documents and assess whether its internal controls, quality systems, policies, or procedures adequately address potential cybersecurity risks or threats or could be improved.

EBG will continue to monitor all developments in FDA’s regulation of and policies related to medical device cybersecurity.

On November 2, 2018 CMS announced the finalization of the 2019 OPPS and ASC payment rules which were initially proposed in July of 2018.[1] [2] While the final document will not be officially published until November 21st, an Inspection Copy is available for the public to review on the Federal Register website. These new payment rules in many ways expand the range of services that CMS will reimburse when performed at Ambulatory Surgical Centers (ASCs), most notably, by including certain cardiac catheterization procedures on the approved list, and by lowering the threshold that determines allowable device intensive procedures.

Increase in Covered Cardiac Catheterization Procedures:

The Final Rule will add 17 procedures relating to cardiac catheterization to the list of ASC Covered Surgical Procedures.  The final list includes five procedures that were not included in the July 2018 proposed rule, due in part to commenters requesting that additional procedures be added to the list, and CMS adopting their request, at least in part.[3] [4] [5] The expanded list reflects the growing trend of cardiac procedures being transitioned from an inpatient to an outpatient setting. This shift will have a continuing business impact on inpatient providers and may also lead to state-level regulatory changes. States that currently prohibit cardiac catheterization procedures at outpatient facilities may decide to adopt changes to allow certain procedures that have been deemed acceptable by CMS to be performed at facilities without on-site inpatient services, including ASCs.[6] Furthermore, these additions could be a springboard for CMS to later add more complicated procedures to the list of ASC covered services.

Decrease in Device Offset Percentage:

CMS has also taken steps to make device-intensive procedures more accessible in the ASC setting. Procedures categorized as “device-intensive” are paid at the higher OPPS rate, even if performed in an ASC.  However, a procedure only qualifies as “device-intensive” if the portion of the procedure’s cost related to the device falls within a predetermine percentage. The Final Rule decreases the device offset percentage threshold from 40 percent to 30 percent, meaning that procedures utilizing lower-cost devices will now be eligible for reimbursement as “device-intensive.”  As a result, ASCs will have the financial capacity to perform more procedures that involve lower cost medical devices.[7] CMS directly states its purpose behind this move saying “We believe allowing these additional procedures to qualify for device-intensive status will help ensure these procedures receive more appropriate payment in the ASC setting, which will help encourage the provision of these services in the ASC setting.”[8] The implementation of the new payment rules will undoubtedly lead to an increase in the amount of device-intensive procedures performed in the ASC setting as ASCs expand their scope of services to include more device-intensive procedures and patients choose to have these procedures performed in an outpatient setting. This change may also indicate future moves by CMS to encourage complex, device intensive procedures, such as joint replacements, in the ASC setting.

Government Shift to Outpatient Providers

These rule changes reflect Medicare’s continued shift towards encouraging services to be provided in the less costly outpatient setting. Anticipating a continued incline in the amount of individuals eligible for federal programs based on the expectation that 10,000 baby boomers will retire per day for over the next decade, CMS is likely to continue making changes to its payment rules to encourage the provision of care in lower cost settings.[9] These changes provide opportunities for ASCs and physicians to expand their business, but also threaten more “bread and butter” revenue streams on which hospitals have historically relied. Thus, hospitals, ASCs and physicians should consider addressing these changes in their long-term strategic plans, including possible joint ventures for outpatient services, in general, or specific service lines, such as cardiac catheterizations.

____

[1] CMS Inspection Copy

[2] 83 Fed. Reg. 37046.

[3] CMS Inspection Copy (at page 746)

[4] 83 Fed. Reg. 37046, 37160.

[5] CMS Inspection Copy (at page 743-44)

[6] N.J.A.C. 8:33E-1.3.

[7] 83 Fed. Reg. 37046, 37108.

[8] Id.

[9] http://www.pewresearch.org/fact-tank/2010/12/29/baby-boomers-retire/

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude products costing under $35 per month for a 30-day supply or a typical course of treatment.

CMS prescribes specific language for manufacturers to use at the end of an advertisement:

The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.

The list price is determined “on the first day of the quarter during which the advertisement is being aired or otherwise broadcast.” This pricing statement must be legible, “placed appropriately against a contrasting background for sufficient duration,” and must be in an easily read font and size. Manufacturers are permitted under the proposed rule, “[t]o the extent permissible under current laws,” to include a competitor’s current product list price, so long as the disclosure is done in a “truthful, non-misleading way.”

CMS proposes that drug and biological products in violation of the proposed rule would be publically listed on its website. Although CMS acknowledged that it was proposing no other HHS-specific enforcement mechanisms, CMS anticipates an influx in private actions under the Lanham Act as the primary enforcement mechanism if the proposed rule is finalized.

Health and Human Services Secretary Alex Azar emphasized the proposed rule’s intent to mitigate consumer out-of-pocket costs and reduce unnecessary Medicare and Medicaid expenditures. Interested stakeholders can submit comments online to the regulations.gov docket or by mail until December 17, 2018.

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

According to the FDA’s draft guidance issued today, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.”

Under the proposed draft guidance manufacturers will be required to better protect their devices in a more uniform manner as prescribed by the FDA. The new pre-market submission proposals are designed to help guide the industry in designing these digital safety mechanisms from the beginning of product design and development.

The New Guidance covers Premarket Notification (510(k)) submissions (including Traditional, Special, and Abbreviated); De Novo requests; Premarket Approval Applications (PMAs); Product Development Protocols (PDPs) that contain software (including firmware) or programmable logic; as well as software that is a medical device.

While manufacturers are required under Quality System Regulations to establish and maintain procedures for validating the devices design including software validation and risk analysis, FDA is recommending validation include design controls to ensure medical device cybersecurity and maintain medical device safety and effectiveness. Including these design controls may make it easier for FDA to “find your device meets its applicable statutory standard for premarket review.”

The recommendations in the newly released Draft Guidance describe using a more risk-based approach to the design and development of appropriate cybersecurity protections. The FDA wants manufacturers to design programs to follow their devices throughout the device lifecycle, monitor new and potential threats, and issue cybersecurity updates to thwart new attempts at unauthorized digital access of the devices.

Because devices that connect to the internet or wirelessly to other devices pose a new and larger threat to cybersecurity, the FDA is requiring a Cybersecurity Bill of Materials be included in the manufacturers filing to identify key components and accessories that could render the device vulnerable to “hacking”. The FDA is creating a new Tier 1 level of standards for these devices to ensure greater security than Tier 2 devices (those that are not wirelessly or internet connected).

Design controls should include appropriate authorization such as ID’s, passwords, time limited sessions with auto logout, layered authorization (i.e. patient, healthcare professional, technician) should now be used in the design of these devices. Authentication and authorization of critical safety commands will be considered in new submissions. In addition, proper labeling to warn patients and providers of the cyber security risks involved in these devices is essential.

For an updated list of FDA recognized consensus standards the Agency recommends that you refer to the FDA Recognized Consensus Standards Database.

 

 

 

The Florida State Legislature has decided to eliminate its state licensure requirement for clinical laboratories.  Effective July 1, 2018, Florida’s recent legislation (SB 622) repeals the entirety of Chapter 483, Part I of the Florida statutes, and in doing so removes the state licensure requirement for clinical laboratories operating in-state and out-of-state.  Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and therefore, in tow, eliminates section 59A-7.024(1) and as well as all other corresponding regulations.

Currently, all clinical laboratories providing services within the state of Florida must maintain a state license unless you were either: (1) a clinical laboratory operated by the U.S. government; (2) a clinical laboratory that only performed waived tests; or (3) a clinical laboratory that was operated and maintained exclusively for research and teaching purposes that did not provide services to patients.  Furthermore, an out-of-state laboratory testing specimens derived from the state of Florida is also required to obtain Florida state licensure if: (1) the out-of-state laboratory maintains an office, specimen collection station or other facility within the state of Florida (Fla. Adm. Code 59A-7.024); or (2) receives a specimen for examination from a clinical laboratory located within the state of Florida (Fla. Stat. § 483.091).

Beginning July 1, 2018, clinical laboratories and stakeholders will be able to provide their laboratory services in Florida or to Florida healthcare providers as long as they meet federal CLIA certification requirements.  Florida’s Agency for Health Care Administration (AHCA) expects to roll-out notifications regarding the change in state licensure requirements to currently licensed clinical laboratories in approximately two weeks and will post notice on its website.

On January 16, 2018, the Department of Health and Human Services Office of Inspector General (OIG) published its most recent update to the agency’s “Work Plan.”  Of note to Durable Medical Equipment (DME) manufacturers, suppliers and prescribers, OIG signaled increased interest in the investigation of three specific off-the-shelf orthotic devices identified by the HCPCS codes:

  • L0648—back bracing
  • L0650—back bracing
  • L1833—knee bracing

According to OIG, the government paid out $349 million for these braces in 2016, representing a 97% increase from just 2014.  OIG expressed concern that many of the braces were being prescribed without adequate documentation of medical necessity in patient records and also fulfillment in cases where actual physical examination of the patient had occurred over a year prior to the device being provided.

DME manufacturers, suppliers and prescribers of back and knee bracing should be advised that OIG has, and will, start taking a much closer look at any Medicare/Medicaid reimbursements for these devices and one can expect increased scrutiny in this area.

For additional information about this issue, contact the author of this post, Clay Lee, or the Epstein Becker Green attorney who regularly assists you.

The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“Antitrust Division”) released their respective year-end reviews highlighted by aggressive enforcement in the health care industry. The FTC, in particular, indicated that 47% of its enforcement actions during calendar year 2016 took place in the health care industry (including pharmaceuticals and medical devices). Of note were successful challenges to hospital mergers in Pennsylvania (Penn State Hershey Medical Center and Pinnacle Health System), and Illinois (Advocate Health Care Network and North Shore University Health System). In both actions, the FTC was able to convince the court that the merger would likely substantially lessen competition for the provision of general acute-care hospital services in relevant areas in violation of section 7 of the Clayton Act. See FTC v. Penn State Hershey Med. Center, 838 F. 3d 327 (3d Cir. 2016); and FTC v. Advocate Health Care Network et al No. 1:15-cv-11473, 2017 U. S. Dist. LEXIS 37707 (N.D. Ill.Mar. 16, 2017)

The Antitrust Division, in similar fashion, touted its actions to block the mergers of Aetna and Humana, and Anthem and Cigna. Complaints against both mergers were filed simultaneously in July of 2016, and tried before different judges in the Federal District Court for the District of Columbia. After extensive trials, Judge Bates blocked the Aetna/Humana deal, and Judge Amy Berman Jackson blocked the Anthem/Cigna transaction. United States v. Aetna Inc., No. 1:16-cv-1494, 2017 U.S. Dist. LEXIS 8490 (D.D.C. Jan 23, 2017) and United States v. Anthem Inc., No. 1:16-cv-01493, 2017 U.S. Dist. LEXIS 23614 (D.D.C. Feb8, 2017).

In addition to their enforcement activities, the agencies promoted jointly issued policy guidelines, including their “Antitrust Guidance for Human Resources Professionals.” Although not specific to any industry, this guidance has particular relevance to the health care industry. Among other things, this guidance makes clear that naked wage-fixing (such as the wave of wage fixing claims relating to nurses) and no-poaching agreements (that would include agreements not to hire competing physicians) are not only per se illegal, but also subject to criminal prosecution.

While a marginal enforcement shift may be in store as a result of the change in administration, most signs point to a continued focus on the health care industry. Maureen K. Ohlhausen, appointed by President Trump as acting Chair of the FTC, reiterated in a speech recently delivered at the spring meeting of the American Bar Association’s antitrust section, that “[i]t’s extremely important we continue our enforcement in the health care space.” Likewise the Acting Director of the FTC’s Bureau of Competition – Abbott (Tad) Lipsky, appointed by Chairman Ohlhausen, applauded the FTC’s success in challenging the Advocate/Northshore Hospital merger noting, in a related FTC press release, that the “merger would likely have reduced the quality, and increased the cost, of health care for residents of the North Shore area of Chicago.”

Makan Delrahim, President Trump’s selection (awaiting confirmation) to head the Antitrust Division, recently lobbied on behalf of Anthem and its efforts to acquire Cigna, and has openly stated with respect to certain announced mergers, that size alone does not create an antitrust problem. Nevertheless, given the political climate and overall impact the health care industry has on the U.S. economy, the Antitrust Division’s efforts to open markets in the health care sector, particularly to generics and new medical technologies by challenging pay for delay deals and scrutinizing unnecessarily restrictive agreements among medical device manufacturers is likely to continue.

A wild card affecting future antitrust enforcement is increasing possibility of passage of the Standard Merger and Acquisitions Review Through Equal Rights Act of 2017 (H.R. 659 a/k/a the “SMARTER ACT”). This bill, recently approved by the House Judiciary Committee, would eliminate the FTC’s administrative adjudication process as it relates to merger enforcement, forcing the FTC to bring all such actions in court. In addition, it would align current preliminary injunction standards such that both the FTC and DOJ would face the same thresholds required of the Clayton Act rather than the more lenient standard under the FTC Act. A similar bill passed the House in 2016, but was not taken up by the Senate.

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards.”

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”).  Published in the Federal Register on Monday, January 9, 2017, the MDE Standards are a set of design criteria intended to provide individuals with disabilities access to medical diagnostic equipment such as examination tables and chairs (including those used for dental or optical exams), weight scales, radiological equipment, mammography equipment and other equipment used by health professionals for diagnostic purposes. …

Read the full post here.