Developments in 2018

FDA Focus

According to its Medical Device Enforcement and Quality Report, FDA has expanded its oversight through increased inspections both in the United States and abroad, bolstered by the Medical Device Single Audit Program, which involves a single regulatory audit of a device manufacturer’s quality management system to satisfy the requirements of multiple jurisdictions, including the United States, Australia, Brazil, Canada and Japan. As codified in section 510(h) of the FDCA (21 USC § 360(h)), the agency reiterated that it continues to take a risk-based enforcement approach to address specific device areas of concern, citing its enforcement and related regulatory action around infusion pumps, automatic external defibrillators and radiation therapy devices in the past several years. FDA also noted that it has taken a more “interactive” approach with violative firms, using tools such as untitled letters and regulatory and other meetings in lieu of warning letters. The agency stated that it recognizes this can be more effective in achieving more timely and effective corrective action. Finally, FDA also noted that its focus on 21 CFR Part 806 Medical Devices Reports of Corrections deficiencies during inspections has resulted in an increased number of reported voluntary recalls and adverse event reporting.

510(k) Exemptions

FDA has continued to use its streamlined authority under the Cures Act to exempt more than 70 class I medical device types and more than 1,000 class II medical device types from the requirement to submit a 510(k). These devices may still be subject to other regulatory controls, such as cGMP, being adequately packaged and properly labeled and having current establishment registration and device listings with FDA.  

Multiple Function Device Products

FDA issued its Multiple Function Device Products: Policy and Considerations guidance as part of the agency’s continued efforts to develop a practical and risk-based approach to regulating medical devices and digital health and to interpret the medical software provisions in section 3060(a) of the Cures Act. Click here for a detailed summary.

Unique Device Identification

In recognition of the complexity of implementing the unique identification system and the fact that medical devices often remain in inventory for long periods of time, FDA deferred enforcement of direct marketing deadlines in its Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking guidance (Nov. 2018), which was effective immediately. The new compliance dates and guidelines for the standard date formatting, unique device identifier (UDI) and Global UDI Database (GUDID) submission requirements under 21 CFR §§ 801.18, 801.20, 801.50 and 830.300 are as follows:

Special 510(k) Program

On September 28, 2018, FDA issued The Special 510(k) Program draft guidance, the first guidance the agency has issued on the Special 510(k) Program in 20 years. If finalized, the draft guidance will supersede The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications guidance, issued on March 20, 1998. The original 1998 guidance introduced the Special 510(k): Device Modification option, which allows a manufacturer to use summary information that results from the design control process as the basis for clearing a device modification when a new 510(k) is needed, provided the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device.

As an incentive to use the Special 510(k) process, FDA stated that it intends to process Special 510(k)s within 30 days of receipt (rather than a traditional 90-day goal review timeframe). In the new draft guidance, FDA proposes to expand on the types of changes eligible for the Special 510(k) Program. Specifically, if finalized as proposed, it includes certain changes to the indications for use (i.e., labeling) and clarifications on the types of technological (i.e., design) changes eligible to be reviewed as a Special 510(k). SaMD developers may be able to use the Special 510(k) pathway, provided that the original 510(k) appropriately identified the verification and validation approaches used. In the draft guidance, FDA reiterates that only the original manufacturer may avail itself of the Special 510(k) Program, because only a manufacturer that modifies its own legally marketed device is able to conduct the risk analysis and necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements in a streamlined 510(k) submission. The draft guidance also proposes, however, that a design or labeling change to an existing device (including changes to indications for use) may be appropriate for a special 510(k) if:

• Performance data are unnecessary, or if performance testing is required to evaluate a change, a well-established method must be used to evaluate the change

• Data submitted with a Special 510(k) must be reviewable in a summary or risk analysis format

Section 523 of the FDCA authorizes FDA to accredit third parties to review pre-market notification (510(k)) submissions and recommend classification of certain devices, specifically class I devices and class II devices, except those intended to be permanently implantable or life sustaining or life supporting, or combination drug/device products. As compared to submissions sent directly to FDA, the program provides expedited FDA review, as FDA will issue a substantial equivalence determination within 30 days’ receipt of a recommendation from a Third Party (3P) Review Organization rather than in 90 days. On September 14, 2018, FDA issued a revised 510(k) Third Party Review Program draft guidance, in which FDA seeks to harmonize terms used by the IMDRF Medical Device Single Audit Program. The draft guidance primarily discusses how a 3P Review Organization should apply for recognition and re-recognition, and the 3P Review Organization’s 510(k) review process itself. The latter remains largely unchanged from the previous guidance, but FDA now offers substantially more guidance on recognition or re-recognition (previously accreditation or re-accreditation) requirements. Notably, FDA advises 3P Review Organizations to submit applications for recognition within six months after the finalization of the draft guidance.

Abbreviated 510(k) Program

When there is a recognized standard specific to a type of device, an abbreviated 510(k) may be an appropriate pathway to gain regulatory approval. The April Expansion of Abbreviated 510(k) Program – SE Through Performance Criteria draft guidance describes an optional pathway for certain types of devices, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device. Specifically, a submitter could demonstrate conformance to objective performance criteria established in FDA guidance, FDA-recognized consensus standards or special controls in lieu of providing data from direct comparison testing between the submitter’s device and the legally marketed device. The use of performance criteria is only appropriate when FDA has determined that (1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate, (2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device and (3) the new device meets the performance criteria. FDA plans to maintain a list of device types appropriate for the Expanded Abbreviated 510(k) program, which would include guidance documents that identify the performance criteria for each device type.

Q-Submission Program

In June, FDA issued its Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program draft guidance, which replaces the 2017 Requests for Feedback on Medical Device Submission: The Pre-Submission Program and Meetings with Food and Drug Administration Staff guidance. The new draft guidance captures changes under the Medical Device User Fee Amendments of 2017 (MDUFA IV). FDA will communicate with the applicant regarding whether a Q-Submission (Q-Sub) application—which includes Pre-Submission Requests, Submission Issue Requests, Study Risk Determination Requests, Informational Meeting Requests, Premarket Approval (PMA) Day 100 Meetings, Agreement Meeting and Determination Meeting Requests, Designation Requests for a Breakthrough Device, Qualification of Medical Device Development Tools requests, Accessory Classification Requests, requests for recognition of publicly accessible genetic variant database requests, combination product agreement meeting requests and requests for waivers under 21 CFR § 812.28. The guidance also provides several general clarifications about the Q-Sub program.

Looking Ahead to 2019

FDA stated that it will continue to focus on collaboration with industry and other stakeholders to drive compliance and promote device quality. CDER launched a voluntary quality maturity appraisal pilot, which uses third-party teams certified by the Capability Maturity Model Integration Institute (CMMI) to conduct quality system maturity appraisals to drive continuous improvement and organizational excellence among participating device manufacturers. The agency will evaluate whether to continue the pilot through a formal appraisal program to complement its traditional oversight activities.

Read more on FDA 2018 Year in Review.