No Time Like the Present: FDA Issues Numerous Device-Specific Guidance Documents in 2018 – 1st Installment

Suzan Onel and Jacqueline Chan[1]

2018 has been notable for many reasons, not the least of which has been the flood of guidance documents FDA has issued related to medical devices.  This KKB Alert highlights some of the most notable device guidances issued between January 1 and August 30, 2018, as they relate to (1) the implementation of legislative directives in the 21st Century Cures Act (“21CCA”)[1] and the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”), (2) the strategic priorities of the Center for Devices and Radiological Health (“CDRH”), (3) premarket submissions, and (4) postmarket responsibilities and activities.  For ease of review, we will post our summary in four parts across four consecutive days to correspond with each of these topics.

I.  Guidances Related to Legislative Directives

As a quick refresher, and because many important FDA guidance documents were issued at the close of 2017, we briefly describe the most notable provisions of 21CCA and FDARA and several end of year guidances as a lead in to   the discussion of the 2018 guidance documents.

A.  21CCA

21CCA amended the Federal Food, Drug, and Cosmetic Act’s (“FDCA”) regulation of combination products under section 503(g) to clarify how the Agency should determine if a combination product is to be regulated primarily as a device or as a drug, and by which FDA Center, and to streamline the combination product review process.  Among other changes, 21CCA clarified that the primary mode of action of a combination product shall not be determined solely based on whether the combination product has any chemical action within or on the human body.[1]  In September 2017, FDA issued final guidance, “Classification of Products as Drugs and Devices & Additional Product Classification Issues,” that described the factors the Agency intends to consider in the classification of a combination product consistent with the new statutory provision.  For example, the guidance explains that a product can have a chemical action and be a device so long as the product does not achieve its primary intended purposes through that chemical action.

Under 21CCA, FDA is required to publish final guidance by 2020 to communicate a process for managing pre-submission interactions with combination product sponsors, best practices for ensuring FDA feedback provides sponsors with current FDA thinking based on the information available, and a defined process for procedural matters, such as meetings and agreements.  As of the date of this publication, such guidance has not been issued; however, FDA has updated several other guidance documents to touch on these topics.  These guidances are discussed in Section III below.

Under 21CCA, Congress also amended the FDCA by adding section 520(o), which excludes five categories of software from the definition of “device,” thus exempting them from FDA regulation.  We discussed these categories in detail in our earlier blog post.

Given the far-reaching implications of this provision, FDA issued the following guidance documents in December 2017 to help clarify the Agency’s interpretation of 21CCA’s amended device definition with respect to software products and how this affects other, existing FDA guidances related to medical device software.

  • Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (Dec. 8, 2017) (Draft Guidance) – This draft guidance discusses the first four software categories that 21CCA exempted from the definition of “device.” It provides examples of each category as well as initial revisions that FDA intends to make to existing guidances implicated by the new device definition. When final, the content of this guidance will be incorporated into the following guidance documents: General Wellness: Policy for Low Risk Devices (July 29, 2016); Mobile Medical Applications (Feb. 9, 2015); Off-The-Shelf Software Use in Medical Devices (Sept. 9, 1999), and Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Feb. 9, 2015).
  • Clinical and Patient Decision Support Software (Draft Guidance) (Dec. 8, 2017) – This draft guidance provides FDA’s thinking on the scope of FDA’s regulatory oversight over the fifth category of software products exempted by 21CCA from the definition of “device” – clinical decision support software (“CDSS”) intended for healthcare professionals. Given the many interpretations of “clinical decision support” (“CDS”), the draft guidance provides a definition for CDS that aligns with 21CCA.  The draft guidance further clarifies the types of decision support software functionalities (1) that do not meet the 21CCA amended definition for “device,” (2) that may meet the definition of a “device” but for which FDA does not intend to enforce compliance with applicable device requirements, and (3) for which FDA intends to focus its regulatory oversight.
  • FDA also states that it intends to exercise its enforcement discretion over patient decision support software (“PDSS”), which it considers software with CDS functions, but intended for patients and caregivers who are not healthcare providers. This category of software functionalities was not exempted from the definition of “device” under 21CCA.  Because of the low risk nature of some of these devices, FDA intends to adopt an enforcement discretion policy for PDSS that generally parallels CDSS excluded from the device definition and provides representative examples of PDSS that fall within its enforcement discretion or its regulatory oversight.
  • Once the draft guidance is finalized, FDA intends to make conforming edits to the Mobile Medical Applications guidance.

21CCA also included a provision that stated that FDA will not regulate software functions that do not meet the definition of “device” for a product with “multiple functions.”[2]  In April 2018, FDA issued a draft guidance, “Multiple Function Device Products: Policy and Considerations,” to clarify how FDA intends to regulate “multiple function device products” (i.e., products that contain at least one “device” function and at least one other function) and to provide guidance on the type of information to be included in a premarket submission.  The guidance includes examples of multiple function devices and states that FDA does not intend to review any “non-device functions” (including those device functions subject to FDA’s enforcement discretion policy), but notes that it may assess the non-device function’s impact on the safety and effectiveness of the device-function for which clearance or approval is being sought.

21CCA further mandated that FDA publish a draft guidance defining the criteria for establishing “probable benefit” as used in FDCA § 520(m)(2)(C) related to the Humanitarian Device Exemption (“HDE”).  In June 2018, FDA provided an updated version of the HDE draft guidance, “Humanitarian Device Exemption (HDE) Program,” in which FDA defined “probable benefit” as “present when there is evidence for FDA to reasonably conclude that patients are likely to benefit from use of the device.” FDA’s HDE review will be based on several factors, such as type and magnitude of benefit(s), probability of the patient experiencing one or more benefit(s), durations of effect(s) and patient perspectives.  The guidance also reflects the change by section 3052 of 21CCA to the threshold number of patients affected by the disease or condition that a humanitarian use device (“HUD”) is intended to treat or diagnose from not more than 4,000 individuals to “not more than 8,000 individuals in the United States.” Additionally, the guidance reflects changes made to the HDE provisions by FDARA, which now allow for an HDE at a facility to treat or diagnose patients to be approved by an institutional review board (“IRB”) or an “appropriate local committee” (as defined in the guidance).  FDA cautions, however, that such “appropriate local committee” may not review or approve a clinical investigation of a HUD; only an IRB may do so.

Finally, 21CCA provided some enhancements to the statutory requirement that FDA considers the “least burdensome” approach to medical device premarket evaluation, including requiring training and oversight to FDA employees, auditing by the FDA ombudsman of the effectiveness of training, and requiring FDA summaries of significant device regulatory decisions describing how least burdensome requirements were considered in the action.  Subsequently, in December 2017, FDA issued a draft guidance, “The Least Burdensome Provisions: Concept and Principles,” implementing the additional “least burdensome” provisions from 21CCA as well as the FDA Safety and Innovation Act (“FDASIA”).  Our colleague, K.S. Reagan, discussed this draft guidance in a previous blog post.


FDARA primarily reauthorized the Medical Device User Fee Amendments (“MDUFA”) to allow FDA to collect medical device user fees for fiscal years 2018-2022.  Although the structure of the user fee program remained largely the same, FDARA created a new user fee for de novo classification requests and removed FDA’s discretion to waive user fees in the interest of public health.  FDA issued user fees for fiscal year 2019 on July 30, 2018, which can be found here.  Some key user fees are the following:

  • 510(k) submission: $10,953 (standard); $2,738 (small business)
  • Premarket Approval Application (“PMA”) submission: $322,147 (standard); $80,537 (small business)
  • De Novo Classification Request: $96,644 (standard); $24,161 (small business)

Additionally, FDARA amended the FDCA’s device classification provision in section 513 to allow accessories to be classified separately from the parent device. This amendment explicitly recognizes that some accessories have a lower risk profile than that of their parent device and thus may warrant being regulated in a lower class.

FDARA also created two new accessory classification pathways that are codified under FDCA section 513(f)(6):  (1) the “New Accessory Request” for an accessory of a type that has not been previously classified under the FDCA, cleared under a 510(k) submission, or approved in a PMA, and (2) the “Existing Accessory Request” to request an “appropriate” classification of an accessory that has been granted marketing authorization as part of a submission for another device with which the accessory is intended to be used.  FDA issued a final guidance document, “Medical Device Accessories – Describing Accessories and Classification Pathways” in December 2017, providing specific information on these two new pathways with information on what should be included in these requests.  Of note, this final guidance supersedes FDA’s earlier final guidance issued on January 30, 2017.

Separately, FDARA charged FDA to issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing by original equipment manufacturers (“OEMs”) and third-party entities.  FDA issued this report in May 2018.  See “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (May 2018).  The report found that currently available objective evidence is not sufficient to conclude whether there is widespread public health concern related to servicing by OEMs or third-party servicers that would require additional or different regulatory requirements at this time.  Instead, FDA found that objective evidence indicates that many OEMs and third-party entities provide high quality, safe, and effective servicing of medical devices.  As a result, FDA does not intend to impose new regulatory requirements, but will (1) promote the adoption of quality management principles, (2) clarify the difference between servicing and remanufacturing, (3) strengthen cybersecurity practices associated with servicing of medical devices, and (4) foster evidence development to assess the quality, safety, and effectiveness of medical device servicing.

FDARA also amended FDCA section 801 to mandate that FDA provide additional clarity regarding its rationale for a denial of a certificate to foreign government (“CFG”) requested pursuant to that section and also issue related guidance.  In August 2018, FDA issued the draft guidance, “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” which provides a non-inclusive list of reasons that FDA may deny a request for issuance of a CFG, including: (1) an injunction proceeding pursuant to FDCA § 302; (2) a seizure action pursuant to FDCA § 304; (3) the device is the subject of a recall designated by FDA as Class I or Class II; or (4) an establishment is out of compliance with the Quality System Regulations  (“QSRs”).  According to the guidance, FDA may not deny a CFG request solely based on (1) an establishment’s receipt of a FDA Form 483 or (2) observations provided in a report issued to an establishment participating in an audit program in which the United States participates or recognizes, if the manufacturer has agreed to a plan of correction in response (the steps of which are noted in the guidance).  FDA will provide written notification to the requestor specifically explaining the basis for denying the request.  Under the draft guidance, manufacturers can request review of FDA’s denial of a CFG request (i.e., by contacting the Exports Branch of CDRH or CBER) and the guidance describes the process by which FDA will conduct such review.  Because CDRH does not consider a denial of a CFG request to be a “significant decision” per FDCA section § 517(a)(1), it will not subject the review process to a 30-day timeframe for filing and review.

Finally, FDARA required FDA to issue or finalize guidance documents on other issues, including (1) the eligibility of class I or class II device types for third-party review of 510(k) submissions and (2) hearing aid devices and personal sound amplification products.  These guidances have yet to be issued.

[1] The authors gratefully acknowledge the contributions to this Alert by Dan Logan, KKB associate, and Celeste Wheeler, former KKB associate.

[1] Pub. L. No. 114-255 (2016).

[1] FDCA § 503(g)(1)(E).

[2] See FDCA § 520(o)(2).