It is becoming increasingly common for medical device companies to conduct clinical studies outside the United States and then seek to use data from these foreign studies in regulatory submissions to FDA. In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies in premarket device submissions.
On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.” FDA issues this guidance at a time when the clinical research community is “showing greater interest” in using electronic media. Continue Reading
The China Food and Drug Administration (CFDA) has revised its good manufacturing practices (GMPs) for medical devices and taken steps to increase enforcement. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China.
A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.
Last week, a German court referred a liability case involving breast implants to the Court of Justice of the European Union (CJEU) to provide further clarity on the responsibilities and liability scheme for medical devices in the European Union. The key questions relate to the responsibility of the Notified Bodies, which are in charge of granting the CE mark that is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies in the EU and could also be relevant for the liability of medical device manufacturers in the EU.
On March 19, 2015, FDA published a public workshop notice entitled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment.” This meeting is being held on April 21 in order for FDA to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise in the postmarket setting.” These risks may be novel risks that were not known at the time of FDA approval or clearance or they may be known risks that are occurring at an unexpected rate in the clinical setting or in unexpected populations or use environments. Continue Reading
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.