The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its fiscal year 2014 plans for guidance development.

Prioritized Areas Of Focus Include the following Final and Draft Topics:

Final Guidance Topics

  • Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A
  • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The Pre-Submission Program and Meetings with FDA Staff
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • Types of Communication During the Review of Medical Device Submissions
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents
  • Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  • In Vitro Companion Diagnostic Devices
  • Global Unique Device Identification Database
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices

Draft Guidance Topics

  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
  • Custom Devices
  • Hearing Aids and Personal Sound Amplification Products (PSAPs)
For more information and to provide comments on the proposed guidance documents planning visit the CDRH website: HERE

Proposal for Cardiovascular Registries

The FDA filed a Notice of Public Meeting and Request for Comments regarding what it is calling the "International Consortium of Cardiovascular Registries."  The purpose is to discuss the development of the registry and to garner feedback from interested parties on the following topics:

  • The role of registry consortia in postmarket surveillance
  • Goals of the International Consortium of Cardiovascular Registries,
  • Lessons learned from the development of the ICOR,
  • Development of an international consortium of transcatheter valve registries as a pilot phase,
  • Analysis of near- and long-term outcomes reported through registries, and
  • Discussion of capabilities, challenges, and limitations of existing transcatheter valve registries.

The FDA indicates that the effort will be modeled on the International Consortium of Orthopedic Registries (ICOR) and will begin with transcatheter valve therapy devices and procedures.

The The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.

More Information


FDA Seeks Increased Efficiency of Review Process

The Food and Drug Administration (FDA) has issued Draft Guidance for Industry and Food and Drug Administration Staff regarding the types of Communication During the Review of Medical Device Submissions.  The FDA is seeking feedback on the proposed guidance rules.  This guidance updates the Agency's approach to Interactive Review.  It now reflects the FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). It also incorporates additional types of communication, all of which are designed to increase the efficiency of the review process. (Download PDF)

The concept of the Interactive Review was discussed in detail as part of the Medical Device User Fee Act (MDUFA) II of 2007.  The process was further described in the guidance “Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.”  (Download PDF)

Additional funds obtained from user fees will enable the FDA, with the cooperation of industry, to improve the device review process.  The FDA seeks to implement improvements for the medical device review process that will provide further transparency into the review process.  Improvements include new communication commitments.  These additional communications are in the context of:  acceptance review; substantive interactions; and, if applicable, missed MDUFA goals.

This guidance describes four types of communication during the review of a medical device submission:

  1. Acceptance Review Communication for premarket notification submissions (510(k)s), original premarket approval applications (Original PMAs), and Panel-Track PMA Supplements
  2. Substantive Interaction for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements;
  3. Interactive Review for 510(k)s, Original PMAs, PMA Supplements, original Biologics License Applications (Original BLAs), and BLA Supplements
  4. Missed MDUFA Decision Communication for 510(k)s, Original PMAs, and Panel-Track PMA Supplements

Through the Interactive Review process the FDA seeks to facilitate efficient and timely review of premarket submissions.  Increased informal interaction between FDA and applicants will include the exchange of scientific and regulatory information.

The Interactive Review process is designed to help accomplish the following:

  1. Improve the interaction between the FDA review staff and the applicant during the review process;
  2. Prevent unnecessary delays in the completion of the review, thus reducing the overall time to market;
  3. Ensure that FDA’s concerns are clearly communicated to the applicant during the review process, as appropriate;
  4. Minimize the number of review cycles;
  5. Minimize the number of review questions conveyed through deficiency letters; and
  6. Ensure timely responses from applicants.
  7. Interactive Review has no start/stop impact on the review clock.

Types of Deficiencies Appropriate for Interactive Review

More significant than “minor,” but that can likely be addressed by the applicant in a time frame that would allow FDA review of the response prior to the MDUFA performance goal for that submission type without placing the submission on hold.

Examples include, but are not limited to:

  1. Requests for limited additional short-term laboratory bench or biocompatibility testing
  2. Further justification for the omission of a test
  3. Additional statistical analysis of the clinical data not related to the primary safety or effectiveness endpoint

Timing of Interactive Review

Interactive Review After Substantive Interaction for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements

Any new deficiencies (i.e., deficiencies not raised as part of the Substantive Interaction) should be limited to issues raised by the information provided by the applicant in its response, unless the reviewer concludes (and received supervisory concurrence) that the initial deficiencies identified do not adequately address important issues materially relevant to a decision of substantial equivalence (510(k)) or safety and effectiveness (PMA).19  For example, following the communication of deficiencies in a 510(k) AI letter, FDA might become aware of a heightened potential for device failure through a series of recalls on other devices with a similar feature.  If these recalls indicate that the particular bench test performed by the applicant to evaluate this feature is not predictive of clinical performance, an FDA reviewer, with appropriate supervisory concurrence, might request additional testing to address the safety of this feature to determine substantial equivalence.  As the end of the review cycle approaches, FDA intends to send a communication that lists the remaining issues, limiting the applicant’s response timeframe to a maximum of 7 calendar days and allowing time for FDA to review the response, so that a timely MDUFA decision can be made.

In limited circumstances, a second AI letter for a 510(k) may be appropriate.  One example of such a circumstance would be when a first AI letter indicates that FDA believes no predicate device exists, but the submitter is able to identify a predicate.  A subsequent review of the comparison of the subject device to the newly identified predicate could raise questions appropriate for a second AI request.  Other instances in which a second AI request could be issued should be limited and occur only with concurrence of Division-level management.

Additional Interactive Review

The FDA also encourages the use of Interactive Review at other points in the review process to facilitate the efficient and timely review of a submission.  At FDA’s discretion, Interactive Review can be used:

  • Prior to Substantive Interaction for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements; and
  • As needed for BLAs, BLA supplements, Humanitarian Device Exemptions (HDEs), and Product Development Protocols (PDPs).

FDA should determine an acceptable timeframe for the applicant to provide a response to the deficiencies based on MDUFA, Office, or Center timelines.  The established timeframe should be based on the impending review deadline, the estimated time that the applicant should need to respond, and the estimated time that FDA should need to review the response.

When final, this document will supersede "Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements" dated February 28, 2008.  If interested in providing comments regarding this draft they can be submitted HERE

The Food and Drug Administration, HHS request for comments on effects of extreme weather on medical device safety and quality.

The Food and Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality.  Submit either electronic or written comments by May 10, 2013.  Submit electronic comments to http:// Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FDA is seeking information particularly on the following questions; however, you may respond to any, all, or none of these questions, or you may submit comments on any topic relating to the purposes of this document, regardless of whether a topic is addressed by these questions:

  1. Have you experienced any of the scenarios or any other effects of EW on the safety and effectiveness of medical devices?
  2. How did you respond to extended periods of electrical or network outages or other events related to EW?
  3. In past EW situations, how was communication handled between the manufacturer facility and patients/users about the safe use of products during EW events? How did you provide/ receive information about device failures? Do you have any suggestions for complaint handling during these situations?
  4. How should industry optimize the design, production, and use of medical devices during and after EW events?
  5. How could products be monitored during transport and storage in light of potential interruptions and environmental extremes from EW events?
  6. How can manufacturers best prevent or minimize temporary shortages of medical devices when EW may damage existing inventory or impact just-in-time production of critical components?
  7. In what ways have EW events impacted your manufacturing site? What were the lessons learned during the recovery process as you returned to production? What changes were made as a result of the EW event?
  8. Are there additional steps FDA can take to help industry anticipate, mitigate, or better tolerate the effects of EW?
  9. Are there steps that standards development or other professional organizations can take to support industry to optimally prepare for EW events?

FOR FURTHER INFORMATION CONTACT: Jennifer Kelly, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3429, Silver Spring, MD 20993–0002, This email address is being protected from spambots. You need JavaScript enabled to view it.  (more)

FDA New Proposed Regulations for Clinical Data Submission

The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. They are proposing new requirements for clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application to be conducted in accordance with good clinical practice (GCP).  This will include obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects.

Their intent is to update the FDA standards for acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. The FDA is also proposing amendments to the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States.

The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. Note that comments are due by May 28, 2013


Good Manufacturing Practice Requirements for Combination Products

Earlier this week the FDA released its Final Rules regarding Good Manufacturing Practice Requirements for Combination Products.  The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.

Products Affected Include

  1. Existing Combination Products
    • The FDA will provide help for manufacturers to alter systems as need be for existing products
  2. New Combination Products
  3. Component manufacturers are exempt from the CGMP rules even if a component will be incorporated into the final product.

More Information

Combination Product Definition

Combination products are defined in 21 CFR 3.2(e).  The term combination product includes:

  1. A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
  2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
  3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
  4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

The Russian Federation has a list of slated changes to its Medical Device Regulations for 2013.  Final implementation of the rules changes is still pending.  The Emergo Group discussed the changes with the Russian Ministry of Health and Roszdravnadzor officials and they listed the following potential changes for 2013:

  1. Applicant must obtain an import permit for samples submitted for testing by Rozsdravnadzor.
  2. Applicant must establish agreements with laboratories for any necessary technical and toxicological testing of its device.
  3. Applicant must submit documentation including test reports to Roszdravnadzor.
  4. Roszdravnadzor authorizes expert review of the applicant’s submission.
  5. Expert reviewers determine whether additional clinical testing of device is necessary and provides list of hospitals where such tests should occur.
  6. Roszdravnadzor informs applicant whether clinical tests are required.
  7. Applicant must set up agreements with hospitals where clinical testing will take place.
  8. Applicant provides clinical testing results to Roszdravnadzor.
  9. Roszdravnadzor then sends applicant’s clinical test results out for expert review.
  10. Expert reviewers notify Roszdravnadzor whether clinical test results are acceptable, provide a report of the test review to regulators, and inform Roszdravnadzor whether the device in question can be registered.
  11. Roszdravnadzor issues either a Registration Certificate to applicant based on a positive expert review or a refusal based on a negative review.

More Information can be found at the Emergo Group Website


Medical Device Tax

The Internal Revenue Service (IRS) has issued the Medical Device Tax Final Regulations

The United States Internal Revenue Service (IRS) has released a finalized guidance report on the upcoming 2.3 percent medical device tax. The new tax will become active in January of 2013.

The IRS released a 58-page report on how it will enforce and regulate the upcoming tax. According to the report, the IRS will define a taxable medical device as any device listed with the United States Food and Drug Administration (FDA) under sec. 510(j) of its FFDCA and under 21 CFR pt. 807.

If a device is not listed with the FDA under the regulations listed above, it will not be taxed. However, a device may be taxed if the FDA determines that device should have been listed with the agency. In this situation, the manufacturer of the medical device will be required to pay the 2.3 percent tax starting on the date it was notified of the corrective action by the FDA.

Many medical device companies have publicly stated that they oppose the tax. They argue that the 2.3 percent medical device tax will discourage innovation. In addition, the new tax has been scrutinized due to the way it taxes a company’s income. Since the medical device tax is levied on revenue instead of profit, it may have a disproportionately negative impact on startups and other new medical device manufacturers.

FDA Innovation Pathway

In order to get patients faster access to safe and effective medical devices that address unmet public health needs, the FDA is developing what it calls the "Innovation Pathway." The Innovation Pathway will be a new way of doing business within the FDA's existing regulatory framework. The initiative is particularly focused on breakthrough technology.

The primary goal for the new Innovation Pathway is to shorten the overall time and cost it takes for the development, assessment and review of medical devices.  The FDA also seeks to improve how FDA staff and innovators work together.  Engaging with innovators much earlier, more collaboratively, and in new ways, should help to reduce the time and cost of the entire process.

On April 9, 2012, the FDA's Center for Devices and Radiological Health (CDRH) launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0."  According to the FDA, Innovation Pathway 2.0 offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

The Pathway also serves as a living laboratory to test new tools and methods for breakthrough devices that we may also apply to other technologies to enhance all of our device pre-market programs.


FDA Unique Device Identification

The Food and Drug Administration (FDA) released a proposed the "unique device identifier" rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI.  A UDI system is designed to improve the quality of information in medical device adverse event reports.  This is intended to help the FDA identify product problems more quickly and allow better targeted recalls that will improve patient safety.

United States Senate voted 92-4 passing User Fee Bill

Tuesday June 26th, 2012 the United States Senate has voted 92-4 passing the FDA User Fee Bill and sending it on for Presidential signature.

News and Reactions:

Kaiser Health News: Senate Sends FDA User Fee Bill To Obama; House GOP Putting Pressure On AARP

Mass Device: AdvaMed: MDUFMA III "isn't your father's user fee agreement"

QMED: Boston Scientific Praises Passage of User Fee Bill

MDDI Online: Senate Overwhelmingly Passes Unprecedented Medical Device User Fee Act

Small Companies Facing FDA Issues

A recent report in the June issue of Journal of Medical Devices (Article) highlights the issues facing small companies that deal with the FDA to get medical devices approved.  The study found that predictability of the regulatory process in the United States is a key priority given that two-thirds of the medical device companies surveyed listed this issue as "critically important."

FDA Internal Pilot Program for 510k Review

The FDA is running a pilot program, April 2nd to October 2nd 2012, for review of 510(k) applications.  It is an internal program designed with the following objectives:

  1. Two Tiered Review
    • Quick Review Tier
      • Good Quality submissions can clear as soon as possible but within 30 days
      • Must pass Quick Review Criteria
      • Pass a Total Product Life Cycle (Postmarket) Search
      • Seek clearance for a device for which FDA has review experience and knowledge of expected performance
      • Not need an extensive consult to complete 510(k) review
      • Contain a 510(k) Summary and not a 510(k) Statement
    • Regular Review Tier
      • Normal 510(k) review, clear within 90 days
  2. Reduce the review time of Traditional 510(k) applications that are of good quality
    • Creates an incentive to sponsors to submit good quality applications to OIVD
  3. Diminish the effort and time reviewers dedicate to Traditional 510(k) applications for products that are well known to the Office
  4. Attain faster product availability
  5. Increase reviewer time for other work-related activities such as training/continuing education, or other regulatory activities

Pilot Triage Flowchart


Draft Guidance from FDA on Benefit-Risk

For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during pre-market review of certain medical devices.

FDA Seeking Public Comments on 510k Program

In a Press Release the FDA announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's - IOM - report on the 510k program, the most common pathway to market for lower-risk medical devices.

Institute of Medicine releases study of the FDA 510k process

The Institute of Medicine - IOM - released its study of the FDA CDRH 510k process for Medical Device approval.  The committee recommends that the FDA should invest in developing a new regulatory framework to replace the, quote, flawed 510k medical device clearance process.  They cite that the FDA's limited legal power and resources cause the 510k process to be and unreliable screen for safety and effectiveness of moderate-risk Class II devices.

Draft FDA Guidance for 510k device changes

FDA's Center for Devices and Radiological Health announced the release of the draft of the FDA's guidance for 510k device changes.   Jeffrey Shuren, M.D., director of FDA's CDRH, stated that "We are making the regulatory process for medical devices less challenging by better describing our expectations."  "In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money."

Draft FDA Guidance for 510k device changes

FDA Seeks to "Strengthen" CDRH

The FDA Center for Devices and Radiological Health - CDRH - continues it's efforts to, as it states, strengthen CDRH and increase our ability to protect and promote the public health through the implementation of changes and improvements. CDRH 2011 Strategic Priorities PDF

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