Devices
FDA says it has changed the way in which CDRH communicates about medical device recalls. As of 1/3, it says, information will be posted in the searchable Medical Device Recalls Database much earlier than previously. Now, the information will be posted when a firm takes a correction or removal
Devices
FDA has issued a guidance, Postmarket Management of Cybersecurity in Medical Devices, to inform industry of its recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. The document says that in addition to the specific recommendations in the guidance, manufacturers are encouraged to address cybersecurity throughout the
Drugs
The Department of Justice (DoJ) says it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2016, including $2.5 billion from the healthcare industry (drug companies, medical device companies, hospitals, nursing homes, laboratories, and doctors)
Devices
FDA has cleared a St. Jude Medical 510(k) for its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sensor Enabled, a new cardiac mapping system. The device is “designed to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart
Drugs
The HHS Inspector General finalized 12/7 a rule amending the safe harbor regulations under the federal healthcare program antikickback law and established exceptions to the civil monetary penalty prohibiting remuneration to Medicare and Medicaid beneficiaries. Attorneys Alan Kirschenbaum and David Gibbons (Hyman, Phelps & McNamara) write in their firm’
Devices
AdvaMed says that while it supports development of guidance by both FDA and the International Medical Device Regulators Forum (IMDRF) to help companies understand when clinical evaluation may be needed to demonstrate a reasonable assurance of safety and effectiveness for software intended for one or more medical purposes without being
Devices
FDA has partnered with the National Institutes of Health and the Department of Defense to more fully capture the patient experience with LASIK (laser-assisted in situ keratomileusis) and is using the data in a valid Web-based questionnaire that can be used to assess patients before and after surgery.
Drugs
FDA and HHS’ Office for Human Research Protections have released a guidance on “Use of Electronic Informed Consent (eIC) — Questions and Answers” that provides recommendations on procedures that may be followed when using an electronic informed consent. The document addresses topics such as how to present information in the eIC
Devices
FDA has finalized a guidance on “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) that describes CDRH’s policy for notifying the public about medical device “emerging signals.” According to the guidance, an emerging signal is new information about a marketed medical device: 1) that supports a new
Devices
CDRH says it does not require device makers to file Medical Device Reporting (MDR) submissions if their device is being used outside the U.S. for a different intended use and the malfunction or death or serious injury are related to that different use — and not the same use that
Drugs
President Obama 12/13 signed into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 10 years. The new law also builds on the agency’s “ongoing efforts to advance medical product innovation and ensure that patients get access to
Drugs
The Association of American Medical Colleges (AAMC) says that an FDA draft guidance on procedures for evaluating appearance issues and granting authorization for participation in FDA advisory committees would benefit from additional clarification. The association also says it is pleased that the agency drafted the document, which seeks to explain
Devices
Attorneys Nathan Brown, Marlee Gallant, and Eli Tomar (Akin Gump) say that new authorities in the 21st Century Cures Act give FDA greater flexibility in regulating medical devices, but their ultimate impact will depend on how they are implemented by the agency under a new administration. Writing in an online
Devices
Washington Legal Foundation (WLF) says there is “much to commend” in an FDA draft guidance on when to submit a 510(k) for a change to an existing device. It also offers several suggested changes. “While the current guidance document (issued in 1997) has served manufacturers well for many years,
Devices
The Medical Device Manufacturers Association (MDMA) says it is concerned about an FDA estimate that there are no capital costs or operating and maintenance costs associated with the agency’s proposed collection of information on the unique device identification system. “This is concerning as this assumption suggests that medical device
Devices
Centurion has begun a Class 1 recall of its Multi-Med Single Lumen Catheters due to excess material at the tip that may split or separate. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. “This can result in
Drugs
FDA officials writing in the 12/8 New England Journal of Medicine express caution about “real world evidence” and its potential to contribute efficiently to current knowledge gained from traditional clinical trials, “whose well-known limitations make it difficult to generalize findings to larger, more inclusive populations of patients, providers,
Devices
ProNova Solutions has received FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning proton therapy system capable of treating patients at all angles without moving the patient. The company says the device features pencil beam scanning and advanced imaging with cone-beam
Devices
FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows for
Devices
Attorneys Jeffrey Shapiro and Jennifer Newberger (Hyman, Phelps & McNamara) say the 21st Century Cures Act, approved by lopsided majorities in the House and Senate and expected to be signed by the president, contains “a host of provisions intended to improve how FDA reviews and approves drugs and medical devices.
Devices
AdvaMed says it supports the principles and concepts in an FDA draft guidance on deciding when to submit a 510(k) for a software change to an existing medical device. The trade association provides recommendations on specific examples in the draft and more detailed comments. “Notwithstanding these comments,” it says,
Devices
FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid. In addition, the agency is considering creating a special over-the-counter (OTC) category for certain hearing aids that will likely lower costs for consumers. “Today’s actions are an example of