September 2015
For updates from the European Commission regarding revision of the European MDD, click the link below:
http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
Blog
FDA updates guidance for its 510(k) Refuse to Accept Policy…
August 2015
FDA released updated guidance addressing its screening acceptance process for 510(k) notifications. FDA has also made corresponding changes to the associated ‘Acceptance Checklist for 510(k)s’.
The revised guidance provides updates explaining the current procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The new guidance is effective on October 1, 2015 and supersedes three predecessor documents from 1993, 1994, and 2012. Links to the revised guidance and updated checklists are provided below:
FDA DRAFT guidance distinguishing device recalls from enhancements…
February 2013
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. The draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by May 23, 2013. Link to federal register notice here.
FDA announces availability of e-submission process for requesting CDRH export certificates…
January 2013
On January 22, FDA announced via Federal Register the availability of an electronic submission process for requesting export certificates for products regulated by FDA’s Center for Devices and Radiological Health (CDRH). The e-process is aimed to help meet certain requirements set out by the FDA Export Reform and Enhancement Act of 1996 and other FDA requirements.
Has FDA recently rejected your medical device submission e-copy?
January 2013
If you’ve had your FDA medical device submission e-copy rejected recently by FDA, you’re probably not alone. When firms submit the mandatory e-copy of their medical device submissions, FDA now requires the e-copy to conform to a mind-boggling array of specifications. Here are links to FDA’s corresponding Federal Register announcement and guidance document.
FDA announces public-private partnership to develop regulatory science and speed access to new device technologies
December 2012
CDRH Accepts Web-based applications for Certificates to Foreign Government
November 2012
CDRH is now accepting web-based applications for Certificates to Foreign Government. The web-based applications are to be submitted electronically through the CDRH Export Certification Application and Tracking System (CECATS). CDRH purports that use of CECATS for CFG applications will offer several benefits, including a reduction in certificate processing time (CFG’s are projected to be issued within 20 business days), real-time validation and status updates.
FDA publishes a revised UDI proposed rule
November 2012
On November 19, 2012, FDA published a revised UDI proposed rule to accommodate the enactment of FDASIA, which was signed into law (Pub. L. 112–144) on July 9, 2012. Specifically, pursuant to FDASIA, the purpose of the revised UDI proposed rule is to specify the date by which a proposed rule is required, to identify particular devices as requiring expedited implementation of UDI requirements, and to specify timeframes for publication of a final rule.
FDA announces significant changes to device registration and listing system
August 2012
For updates from the European Commission regarding revision of the European MDD, click the link below:
http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
Wondering how FDA’s UDI rule might affect labelers? Here’s a non-exhaustive summary
July 2012
• This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week.
• Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage.
• All devices [201(h) of the Act] will require UDI except:
– Those for purchase at retail (except prescription devices)
– Class 1 GMP-exempt
– Certain single-use class 1 devices not intended for individual sale
– Devices solely for research, teaching, or chemical analysis
– Custom, investigational, veterinary, and export-only devices
– Strategic Nat’l Stockpile devices
– Certain sec. 514 performance-standard devices
– Combination-product device-constituents that can’t be used apart from the combination
– Single-use members of convenience kits
• Class 1, 2, and 3 devices must comply by 5 years, 3 yrs, or 1 yr, respectively, after UDI final rulemaking (exception noted below).
• Shipping containers don’t need to display UDI.
• UDI’s must appear on the label and “package” (per UDI-rule definition).
• UDI’s shall have two parts: 1) Device Identifier [mandatory, fixed part identifying the labeler and the “version/ model” (special definition)]; and 2) Production Identifier (variable part for lot, expiry, etc.) when such variables are included on the label.
• Class 1 device UDI’s don’t require a Production Identifier.
• Each UDI must have a plain-text form AND a form based on AIDC technology. If the AIDC form is not conspicuous, then the label must display a special symbol.
• 2 years after the aforementioned phase-in dates, and within certain parameters, the UDI must also permanently appear DIRECTLY ON devices that are a) implantable; b) reusable and must be sterilized before each use; or c) stand-alone software.
• Each device “version/model” must bear a unique UDI. This is driven, among other things, by the fixed quantity of devices in a “package”.
• As currently worded, the proposed rule prohibits labelers from autonomously generating UDI (which may be unique for each unit or lot). Instead, EVERY UDI shall be issued by the FDA, or an FDA-accredited agency. This could have a significant operational impact on labelers, so I encourage readers to think carefully about this during the 120-day comment period.
• Dates on labels must now conform to the following format (today’s date for example): JUL 6, 2012
• UDI format must meet the criteria defined, as applicable, by a) ISO/IEC 646:1991; b) ISO/IEC 15459-2:2006(E); c) ISO/IEC 15459-4:2008; and d) ISO/IEC 15459-6:2007.
• Using various procedures, labelers must submit certain UDI data to FDA for posting in FDA’s online public “GUDID” (Global Unique Device Identification Database).
• GMP: The UDI shall be recorded on device history, complaint, and service records. Label inspection/release shall verify the correct UDI on labels.
• MDR’s & part 806 reports shall reflect the UDI of the subject device.
• Market-status updates in PMA periodic reports shall include UDI Device Identifiers (certain legacies excluded).
• Other UDI topics addressed by the rule include those related, but not limited to, combination products, convenience kits, voluntary UDI, change control, discontinuation of NHRIC and NDC numbers, and others.