Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) — diagnostic tests developed by and used within individual laboratories across the country. As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA), though the FDA has claimed that it has the authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The deadline to comment on FDA’s draft guidance was February 2 with FDA receiving hundreds of comments.
On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices. FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July 2014 (see our previous blog post).
Specifically, FDA states that it does not intend to enforce compliance with FDA regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulations (QSRs), for the following device types:
- Medical device data systems (MDDS) (as defined in 21 C.F.R. § 880.6310),
- Medical image storage devices (as defined in 21 C.F.R. § 892.2010), and
- Medical image communications devices (as defined in 21 C.F.R. § 892.2020).
These devices had been regulated as Class I, 510(k) exempt devices and were, therefore, subject to certain FDA regulatory requirements. FDA is now limiting agency oversight over these device types “due to the low risk they pose to patients and the importance they play in advancing digital health.” Continue Reading
As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST).
Our panelists, including two alumni of the FDA Office of Chief Counsel, will address:
- What factors determine whether an eHealth product is considered a medical device and subject to active FDA regulation?
- What avenues are there to obtain information from FDA about whether your eHealth Product will be actively regulated, and how can you affect/influence that determination?
- What role may eHealth play in personalized medicine and genetic screening, and what are FDA’s policies in this area?
- How might legislation impact the regulation of eHealth products?
- A comparison of FDA regulation of eHealth and mobile apps to regulation in the EU and China.
Click here to register. CLE credit will be available for CA and NY.
Two years after issuing a final rule on current good manufacturing practice (cGMP) requirements for combination products, FDA has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers can comply with cGMP requirements. As we noted in our write-up of the final rule, following the rule’s issuance, industry requested additional guidance from FDA about the rule’s implementation, and FDA promised to provide such guidance. FDA has now made good on that promise.
A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are spread over almost 400 pages. As stated in the white paper accompanying the Draft Act, discussion regarding the proposed changes is still ongoing, and the E&C Committee requests feedback on the proposals.
The Draft Act proposes changes to federal law which, if enacted, could streamline FDA’s premarket review process, establish a new regulatory framework for health software separate from medical software, enhance the efficiency of FDA review of combination products, encourage use of Bayesian and other statistical methodologies for clinical trials, and add supply chain security for devices.
There are also several placeholders in the Draft Act for future provisions that could be very important to the regulation of medical devices, including section 2161 – “Modernizing Regulation of Diagnostics,” section 2181 – “Interoperability,” and section 2301 – “Precision Medicine.” It will be important to continue to monitor this legislation as new provisions are added and modifications are made to the current language. We will continue to report on this draft legislation as it progresses. To read more about these proposed changes to medical device regulation and other features of the Draft Act, see our alert.
The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health
The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, mHealth’s role in healthcare systems, equal access, interoperability, funding and reimbursement, liability, research and innovation, international cooperation, and market access issues, particularly for web entrepreneurs.
As part of Covington’s ongoing Life Sciences Essentials webinar series we will be presenting a program on pharmaceutical and medical device patent litigation trends on February 11, 2015 (12:30-2:00 p.m. EST).
Panelists and topics include:
- Shara Aranoff – Current trends in Section 337 patent litigation at the ITC, including the evolving domestic industry requirement and the heightened focus on public interest and enforcement issues.
- Andrea Reister – The growing wave of Patent Office challenges to pharma patents, the impending tsunami of inter partes review and other challenges from generic applicants, hedge funds, and competitors in the pharmaceutical industry.
- Andrew Lazerow – Current trends in “reverse payment” antitrust litigation in the wake of FTC v. Actavis, the Supreme Court’s only decision in this area of the law standing at the intersection of antitrust law and patent law.
Click here to register. CLE credit will be available for CA and NY.
On December 17, 2014, the Federal Circuit released its decision in the matter of In re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (“In re: BRCA1/2”). Myriad asserted a set of patent claims that were not part of the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics (“Myriad”). The BRCA1/2 lawsuit involved four composition of matter claims directed toward DNA primers and two method claims directed to comparisons between wild-type BRCA gene sequences with a patient’s BRCA gene sequence. The Utah District Court denied Myriad’s motion for preliminary injunction on the basis that the claims were likely drawn to ineligible subject matter. On appeal, the Federal Circuit affirmed the denial of the preliminary injunction and, in addition, invalidated the claims on de novo review as impermissibly claiming natural products and abstract ideas under 35 U.S.C. § 101.
On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct medical device clinical trials used by sponsors to support medical device registration applications for marketing in China. Medical institution is a term in Chinese regulation that is typically used to refer to hospitals and clinics, both public and private. However, nearly half of these institutions are state-owned, and most patient visits occur at state hospitals and clinics.
FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories. Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software industry.
FDA states in the draft guidance “General Wellness: Policy for Low Risk Devices,” that it will not regulate low risk products in one of two categories:
- Category 1: Products intended to maintain or encourage a general state of health or a healthy activity. These products do not make any reference to diseases or medical conditions in the claim. This category of general wellness products relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
- Category 2: Products that associate the role of a healthy lifestyle with helping to reduce the risk or impact of chronic diseases or conditions. An important requirement is that it must be “well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.” Examples provided by FDA of such chronic diseases include heart disease, high blood pressure, and type 2 diabetes.
FDA provides two subcategories of claims under Category 2: (1) “may help to reduce the risk of” and (2) “may help living well with.” Thus, for example, a product that promotes physical activity as part of a healthy lifestyle “may help reduce the risk of” high blood pressure. A software product that tracks caloric intake can help to maintain a healthy weight and balanced diet, which “may help living well” with high blood pressure and type 2 diabetes.
In the Accessories draft guidance “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types,” FDA seeks to clarify and modify its policy concerning the classification of accessories. FDA defines an accessory as a “device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” FDA clarifies that medical device accessories will not automatically take on the classification of the parent device. FDA intends to regulate accessories according to their individual risk in the same way FDA regulates all medical devices, and thus, accessories may be classified differently than the parent device. For example, if the parent device is regulated as a Class III device but the accessory is low risk, the accessory could be regulated as Class I.
There is a 90 day public comment period for these guidances. Further analysis of the draft General Wellness Guidance can be found in our client alert, available here.