Tag Archives: FDA

Regulation of Combination Products: A Hybrid Approach to CGMP and Postmarketing Safety Reporting Requirements

Starting July 22, 2013, as part of their compliance with current good manufacturing practices (“CGMP”), pharmaceutical companies that manufacture combination products containing a device component became subject to device Quality System Regulations (“QSRs”). As we previously discussed, on January 22, 2013, FDA issued a final rule on CGMP requirements for combination products. Under the rule, … Continue Reading

FDA Announces Public Workshop to Discuss Ways to Incorporate Patient Perspectives Into the Medical Device Regulatory Process

FDA recently announced a public workshop to be held on September 18 – 19, 2013 on ways to incorporate patient perspectives on “meaningful benefits” and “acceptable risks” of new medical devices.  The meeting is intended to solicit stakeholder input to discuss ways to collect and validate patient preference information and to inform the use of … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in June 2013

Covington & Burling LLP issues monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, medical devices, and biologics.  In June 2013, FDA’s Office of Prescription Drug Promotion (OPDP) posted one such letter.  Although the Center for Devices and Radiological Health (CDRH) posted no … Continue Reading

FDA Issues Draft Guidance on Medical Device Reporting for Manufacturers

On July 9, 2013, FDA announced the availability of a draft guidance document titled “Medical Device Reporting for Manufacturers.”  Written in a question and answer format, the draft guidance provides FDA’s current views on FDA’s Medical Device Reporting (MDR) regulation, 21 C.F.R. part 803.  Once finalized, the draft guidance will supersede the agency’s previous 1997 … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in May 2013

Covington & Burling LLP issues monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, medical devices, and biologics.  In May 2013, FDA’s Office of Prescription Drug Promotion (OPDP) posted five such letters, and the Office of Compliance and Biologics Quality (OCBQ) in FDA’s … Continue Reading

FDA Proposes New Pre-Decisional IDE Program

Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions.  While that post focused on FDA’s IDE decision-making process and the regulatory implications of those decisions, this post addresses a new program within CDRH—the Pre-Decisional IDE program—that FDA proposed in the draft guidance. To further help applicants reach their goal of device … Continue Reading

FDA Issues Draft Guidance on IDE Decisions and New Pre-Decisional IDE Program

On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to clarify the regulatory implications of FDA’s IDE decisions and to propose a new program to facilitate trial designs in support of marketing approval or clearance. FDA may take three actions with respect to IDE applications: approval, … Continue Reading

FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

FDA Finalizes CDRH Appeals Process Guidance, Issues Draft Guidance on Section 517A

On May 17, 2013, FDA took significant steps to update its appeals process for medical devices.  First, FDA finalized its guidance on CDRH Appeals Processes, which “describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.”  Second, FDA issued a new draft guidance on Questions and Answers … Continue Reading

FDA Takes First Public Mobile App Enforcement Action

FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading

Use of New Administrative Order Authority to Up-Classify Devices: Proposed Order on “Sunlamp Products” Offers Glimpse Into FDA’s Approach

On May 6, 2013, FDA issued a proposed order to reclassify ultraviolet (UV) lamps intended for tanning from class I devices (general controls) exempt from premarket notification to class II devices (special controls) subject to premarket notification.  FDA also proposed to change the focus of the classification regulation from “ultraviolet lamps” to “sunlamp products,” including … Continue Reading

Growth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory Questions

Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users’ lifestyles.  Jawbone’s UP can track sleep, movement, and diet, … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

FDA Plans to Complete Classifications of Preamendment Devices by the End of 2014

Last month, FDA announced that it plans to complete classification actions for remaining preamendments devices by the end of 2014.  These actions could take the form of orders requiring the filing of premarket approval applications (PMAs) or notices of completion of a product development protocol (PDPs) for various devices (referred to as “calls for PMAs”) or reclassification orders.  With the … Continue Reading

Congress Shows Continued Interest In Mobile Medical Apps

Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of a “device.”  On March 1, 2013, six Republican members of the House Committee on Energy and Commerce sent a letter to … Continue Reading

Wireless Medical Device Law and Regulation Takes Center Stage at FCC, FDA, and Congress

Wireless medical devices stand at an innovative crossroad between health care, communications, and technology law and regulation. Many of the health and safety aspects of such devices are regulated by the Food & Drug Administration (FDA) and these devices use electromagnetic spectrum regulated by the Federal Communications Commission (FCC).  Lately, regulators at FDA and FCC … Continue Reading

Rethinking FDA’s Regulation of Mobile Medical Apps

In the Winter/Spring edition of the SciTech Lawyer, published by the American Bar Association’s Section of Science & Technology Law, Scott Danzis and Chris Pruitt argue that FDA should rethink its approach to regulating mobile medical apps, including making significant revisions to its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff: Mobile … Continue Reading

Current Good Manufacturing Practice Rule for Combination Products Issued by FDA

On January 22, 2013, FDA issued a long-awaited final rule on the current good manufacturing practice (“CGMP”) requirements for combination products.  According to FDA, “the final rule is largely identical to the proposed rule,” which was published on September 23, 2009. Under FDA regulations, a combination product includes (among other things) a product comprised of any combination … Continue Reading

FDA Announces Public Workshop to Discuss the Creation of Standardized Medical Device Labeling

FDA recently announced a two-day public workshop in April to obtain feedback from stakeholders about standardizing medical device labeling and creating a publicly available repository of device labeling.  The first day will focus on the creation of accessible, standardized labeling for devices.  The second day will focus on the possible creation of an online repository. … Continue Reading

FDA Requests Comments Regarding Amended “Custom Devices” Exemption

On November 19, 2012, FDA issued a Federal Register notice seeking public comments on amendments to the custom device exemption that were enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).  FDA also announced it intends to issue a draft guidance relating to custom devices in 2013, as the Agency’s … Continue Reading
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