The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted July 9, 2012, is the most recent statute impacting FDA's regulation of medical devices. FDASIA is significant not only because it reauthorizes user fees for device submissions, in exchange for FDA's commitment to achieve certain performance goals in the review of those submissions, but also because it institutes various other changes to the device regulatory framework. Several of these should or may benefit medical device companies, while the impact of others is less apparent. We discuss certain key FDASIA provisions below.
FDASIA reauthorizes the collection of user fees from device companies for fiscal years (FYs) 2013 - 2017. As before FDASIA, fees increase each year. Fee types remain unchanged; however, there is a significant increase in entities that must pay establishment registration fees. Previously, these applied to manufacturers, specification developers, and single-use device reprocessors only; under FDASIA, registration fees now apply to any facility "engaged in the manufacture, preparation, propagation, compounding, or processing of a device." Among others, this includes contract manufacturers, packagers, and sterilizers (whether or not they commercially distribute devices), as well as establishments that maintain device complaint files only.
As before, performance goals focus largely on FDA commitments to review a certain percentage of device submissions within a specified number of days. For example, for 510(k)s, FDA has committed to review 91% within 90 days for FY 2013 (compared to 90% in 90 days for FY 2012); 93% within 90 days for FY 2014; and 95% within 90 days for FYs 2015 - 2017. The days referenced in these goals are "FDA days," meaning days the application is under review by FDA; to address concerns that applications could experience lengthy reviews even while goals for review days by FDA are met, the agency has also committed to "Total Time to Decision" goals, meaning the total number of calendar days from receipt of an accepted or filed submission to a "MDUFA decision" (e.g., clearance or approval), including both "FDA days" and days the submission is with industry for further action. The average "Total Time to Decision" goal for 510(k)s in FY 2013 is 135 days; this will reduce to 124 days in FY 2017. For PMAs, this goal starts at 395 days in FY 2013 and reduces to 385 days by FY 2017.
To improve communications with industry, additional performance goals for FYs 2013 - 2017 include days (from date of PMA filing or 510(k) acceptance) by which FDA will have a "substantive interaction" with applicants (90 calendar days for PMAs and 60 for 510(k)s). Examples of "substantive interactions" include a major deficiency letter or additional information request. FDA has further committed to notifying submitters of the acceptability for review of 510(k)s, PMAs, and certain supplements within 15 days of receipt. Importantly, CDRH has also advised that it will provide written notices to applicants when certain 510(k)s or PMAs have missed their goal dates for decision, which will specify "the major outstanding review topic areas or other reasons that are preventing FDA from reaching a final decision, with an estimated date of completion."
FDA expects $595 million in FDASIA-related user fees and has announced plans to hire more than 200 employees with these funds. Moreover, FDA has committed to using these fees to "reduce the ratio of review staff to...supervisors," provide enhanced training to reviewers and management, and identify best practices for retaining employees. If realized, these efforts should improve FDA's ability to reach its performance goals.
The "Documentation and Review of Significant Decisions" provision of FDASIA could provide a substantial benefit to the device industry by establishing a clear and relatively quick process for obtaining supervisory review of adverse CDRH decisions. This provision requires CDRH to provide applicants with a substantive written summary of the scientific and regulatory rationale underlying any "significant" decision regarding submission or review of an IDE application, 510(k), or PMA. An applicant may request supervisory review of the decision by submitting a request within 30 days of the decision; FDA must schedule a meeting or teleconference review (if requested) within 30 days of the request, and issue a decision within the next 30 days or, if no meeting or teleconference is requested, within 45 days of the request for supervisory review.
Another positive for industry is FDASIA's modification of the de novo application process. Previously, firms seeking to market low-to-moderate risk devices without a predicate first had to complete 510(k) review and receive a "not substantially equivalent" determination before requesting de novo classification of the device into Class I or II. FDASIA eliminates the requirement to go through this process, and instead allows such firms to directly submit a request for de novo classification. FDA must decide on a de novo classification request within 120 days, and may decline a request if it finds that: 1) an available predicate could provide a reasonable basis for review; 2) the device is not low-to-moderate risk; or 3) general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
FDASIA could also be helpful to firms who wish to seek reclassification of their devices. FDASIA authorizes FDA to change a device's classification through an administrative order rather than the more onerous rulemaking process. FDA must still publish a proposal for reclassification in the Federal Register and consider the comments of affected stakeholders; additionally, the proposed order must be reviewed by a device classification panel. However, with elimination of the requirement that FDA issue a new regulation in order to reclassify a device, products that have been "stuck" unnecessarily in Class III or II potentially can be moved more quickly into Class II or I, although "upclassification" efforts initiated by FDA could be more readily achieved as well.
Another perceived victory for industry is FDASIA's requirement that FDA withdraw its highly controversial July 2011 draft guidance regarding the 510(k) implications of device modifications, and reinstate its January 1997 guidance entitled, "Deciding when to Submit a 510(k) for a Change to an Existing Device." Under FDASIA, FDA must report to Congress regarding when a 510(k) should be submitted for modifications to marketed devices, and must not issue related guidance or regulation until one year after Congress receives the report. Industry considered the 2011 draft guidance to be significantly more stringent than the 1997 guidance. Importantly, however, while the former has been withdrawn, the FDA views that shaped it likely still remain. Thus, despite the withdrawal, firms are likely to find themselves operating under stringent regulatory expectations with respect to 510(k) requirements for modifications.
One part of FDASIA that may not deliver all it promises is the "Clarification of Least Burdensome Standard" provision. In 1997, Congress added the "Least Burdensome" provisions to the Food, Drug, and Cosmetic Act (FDC Act), in an attempt to reduce unnecessary regulatory burdens associated with premarket clearance and approval. For example, the FDC Act specifies that, for 510(k)s, when FDA requests information to demonstrate the substantial equivalence of devices with different technological characteristics, only information "necessary" to make a substantial equivalence determination may be requested. Similarly, for PMAs, FDA may only request clinical data that is "necessary" to establish device effectiveness. FDASIA attempts to clarify these provisions by defining "necessary" for 510(k)s as the "minimum required information that would support a determination of substantial equivalence..." For PMAs, FDASIA defines "necessary" as the "minimum required information that would support a determination...that an application provides a reasonable assurance of the effectiveness of the device." FDASIA's focus on the notion of "Least Burdensome" is positive for industry, as it re-emphasizes that excessive data requests during premarket review can unnecessarily slow patient access to new technologies. However, FDASIA does not greatly clarify what "necessary" means, but instead introduces a new term—i.e., "minimum required information"—which requires clarification.
On balance, FDASIA will likely narrow the scope of "custom devices" exempt from 510(k) and PMA requirements. For example, FDASIA stipulates that a custom device must be designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. FDASIA also limits custom devices to use for conditions sufficiently rare that conducting clinical investigations would be impractical, and caps production yearly at five or fewer units of a particular type of custom device. Additionally, firms must now notify FDA annually regarding their manufacture of custom devices. FDA has always interpreted the definition of custom device narrowly, often disagreeing with firms' assertions of custom device status. FDASIA seems to create further challenges for the marketing of these devices.
The recent FDASIA amendments affect FDA and device companies in several important ways. Certain FDASIA provisions could benefit industry, while the implications of others may not be as they first appear. Device firms should carefully assess the impacts and opportunities FDASIA creates for their business models.
Pamela Furman Forrest is a Partner in King & Spalding's FDA/Life Sciences Practice Group. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, labeling and promotion, and clinical research requirements. Ms. Forrest also frequently assists firms in responding to FDA enforcement actions. In addition, much of her work focuses on conducting FDA-related due diligence activities in connection with mergers and acquisitions of medical device firms. She has written and spoken extensively on FDA medical device regulation, and has testified before several state legislative committees regarding medical device legal and regulatory issues. Ms. Forrest graduated summa cum laude, Phi Beta Kappa, from Yale University in 1988, with a Bachelor of Arts in political science. She received her law degree from Stanford Law School in 1994.
Elaine Tseng is a Partner in King & Spalding's FDA and Life Sciences group in San Francisco, California. She previously served as Regulatory Counsel at the Food and Drug Administration. Ms. Tseng specializes in FDA matters and focuses primarily on pre- and post-market regulatory requirements and policies applicable to medical devices. She also has significant experience with FDA regulation of pharmaceuticals and biopharmaceuticals. Ms. Tseng is a graduate of Cornell University and Harvard Law School. She is a recipient of the Secretary for Health and Human Services' Distinguished Service Award and other FDA honors.
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, LLP, specializing in regulatory, enforcement, and policy matters involving industries regulated by the U.S. Food and Drug Administration where he provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics and food industries to assure compliance with the requirements of the federal Food, Drug and Cosmetic Act. He helps firms develop corrective action plans so their business needs are properly balanced with regulatory requirements in order to achieve compliance without comprising objectives. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career where he served as Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He also served as the Director and Deputy Director of FDA's Office of Enforcement, where he also presided as Chairman of FDA's Compliance Policy Council. Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health. Mr. Niedelman has served as Vice President of the FDA Alumnae Association, a member of the Medical Device Committee at the Food and Drug Law Institute, and as a member of the Editorial Review Board for Medical Device Summit and FDA News GMP publications directed at the pharmaceutical and medical devices industry.