Medical Devices Federal Updates
Friday, January 30, 2015
Medical Device Tax Repeal Re-Introduced in Congress
Legislation to repeal the medical device excise tax was introduced in the House by Rep. Paulsen (R-MN) with 262 bipartisan co-sponsors and in the Senate by Finance Chairman Orrin Hatch (R-UT) with 15 bipartisan co-sponsors. If 54 Senate Republicans support the bill, along with the five Democratic sponsors, supporters already have 59 votes in their favor, just one vote shy of filibuster and more Democrats are likely to support at that point. The bill would be retroactive to December 31, 2012, and there’s no known pay-for at this time.
A support letter representing a coalition of repeal proponents was sent to Congressional leadership. The letter included almost 1,000 signatories.
AdvaMed Capitol Hill Legislative Fly-In 2015
MichBio will once again participate in the annual AdvaMed Capitol Hill Fly-In. This year’s event is scheduled for March 4-5, 2015. We’ll head to Congress to advocate on behalf of Michigan’s medical device companies. This is a unique experience to influence the Michigan delegation on medical device issues like repeal of the medical device tax.
AdvaMed provides attendees with a legislative briefing late on Day 1 prior to their visits on Capitol Hill. The session is a quick education on the latest policy issues and the dynamics at work with each. Day 2 of the Fly-In is devoted to meetings with the delegation offices.
MichBio welcomes medtech company executives and/or government relations staff to join us on a select basis. To learn more, please contact firstname.lastname@example.org.
FDA.gov New Guidance Feature
A new feature on the FDA.gov website allows you to search for guidance documents for all topics across the site from one convenient location:
FDA-CDRH Releases “2014-2015 Strategic Priorities: 2014 Update”
The FDA’s Center for Devices & Radiologic Health released its “2014-2015 Strategic Priorities: 2014 Update.” The document is intended to update the public on the progress of each of CDRH’s strategic priorities for 2014-2015: strengthening the clinical trial enterprise, striking the right balance between premarket and postmarket data collection, and providing excellent customer services. In addition, CDRH committed to reviewing previously published final guidance documents, including updating or deleting guidance documents that no longer represent the FDA’s current thinking on a regulatory issue, as well as committing to performance goals in finalizing current and future draft guidance documents.
Draft Guidance on Medical Device Accessories
The FDA issued a draft guidance recently titled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types." This guidance focuses on the utilization of the de novo classification process for "a new type of accessory" with tips on streamlining this accessory de novo submission into either a class I or class II device classification. The FDA proposes to regulate accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices. For example, if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, the accessory would be regulated as a Class I rather than a Class II device.
FDA Unveils New Low-Risk Medical Device Guidance
The FDA is proposing to not enforce regulatory compliance for products that are intended only for general wellness. These products are designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.
Announcing Draft Guidance on Transfer of a Premarket Notification (510(k)) Clearance
The FDA published draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance.” When finalized, this guidance will provide information on:
- How to notify the FDA of the transfer of a 510(k) clearance from one holder to another
- The procedures the FDA and Industry should use to ensure accurate and up-to-date information in the FDA’s databases
The ability to identify the current holder of each 510(k) clearance will ensure that the FDA can locate and contact the correct individual(s) when necessary.
Update on UDI Requirements
Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA- CDRH has summarized recent and upcoming UDI activities and deadlines. The next two compliance dates for UDI requirements are:
- September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
- September 24, 2016 for class II devices
1. Global Unique Device Identification Database (GUDID) Data Submission:
FDA will begin accepting GUDID account requests from labelers of I/LS/LS devices in January 2015. Later in 2015, the agency will accept GUDID account requests from labelers of class II devices. All device labelers are strongly urged to take steps to ensure their readiness to meet UDI requirements well before actual data submission to GUDID. Suggested steps are included on the UDI website.
2. UDI Policy:
The FDA hopes to address a number of identified implementation issues in 2015, such as UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).
The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. Device labelers were required to request such continued use by September 24, 2014, and are urged to do so ASAP if not yet completed.
3. UDI Adoption and Use:
The FDA continues to promote and facilitate UDI adoption in health care settings. For additional information, please see www.fda.gov/udi or contact the FDA UDI Help Desk.