China Adopts Reforms to Medical Device Regulations, Finalizes Fast-Track Program China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Officials have yet to release details of the bill, but AdvaMed, which has consulted with the China Food and Drug Administra- tion on the reforms, says the revisions will be positive. “We’re expecting a lot of approaches to be modernized or strengthened,” Elise Owen, associate vice president of global strategy and analy- sis at the trade group, tells IMDRM. “Most of the regulations we comply with as an industry in China are going to be updated or renewed,” Owens says, noting a recent uptick in CFDA guidelines. Given the expected scope of the overhaul, AdvaMed is pressing the agency for a longer public comment period and more appropriate transition timelines. “We’re looking for six months as opposed to 30 or zero days,” Owens says, noting the CFDA has provided 60 days for comment and six months to comply with other recent requirements. “Everything is changing,” Owens warns. “It’s more impor- tant to be focused on China than ever, because [the fact that] it’s this way today doesn’t mean it’ll be that way tomorrow.” In antic- ipation of the new law, a lot of regulations are being replaced and that will only intensify, she adds. Fast-Track Opened to Foreigners Also last month, the CFDA finalized regulations on fast-track approvals and device reregistration (IMDRM, May 2013). The final versions open both programs to foreign manufacturers — a shift from the drafts, which were limited to Chinese companies. Beyond that, and some confusion regarding patents, the final regulations are largely unchanged, Owens says. “There are still some unanswered questions. But we’ve reached out to CFDA and, so far, we’re seeing their willingness to engage and interact with our members to clear areas of misunderstanding.” Another positive step was a December decree implementing provisions for the CFDA’s legislative process, Owens notes. Not China Adopts Reforms to Medical Device Regulations, Finalizes Fast-Track Program ......... 1 Odds of Seeing EU Device Regs Finalized Before May Elections Increasingly Slim ............... 2 U.S. FDA’s Hamburg Says India Trip Helped Sync Countries’ Goals ....................... 3 India Discloses Sponsor Payouts For Trial-Related Deaths ........................................ 3 Devicemakers Urged to Prepare Now For Mandatory eMDRs in U.S. in 2015 ................. 3 Devices-Only Enforcement Unit Needed To Handle Increasingly Complex Products .......... 4 U.S. FDA Issues Final Guidance On PMA/PDP Pre-Sub Program ........................... 5 U.S. Won’t Expand 510(k) Modification Policy, Sticks With 1997 Guidance ........................ 5 Russian Regulator Requires New Tests For Device Conformity Assessments ..................... 7 PMA Yearly Reports Should Include Reasons for Device Changes: U.S. FDA ................ 7 UK Gives Devicemakers Clearer Guidance on Borderline Products ......................... 8 MHRA: Adverse Incident Reports Increased 23.4 Percent in 2012 ............................... 9 Industry Q&A Guidance Attempts To Demystify RoHS 2 Rules ................................... 9 In Brief ................................................................... 10 Editor’s Note: The International Medical Device Regulatory Monitor is available in an electronic edition, which includes web access to seven years of archived issues. For information on convert- ing to an electronic subscription, contact us at (888) 838-5578. I N T E R N A T I O N A L M E D I C A L D E V I C E R E G U L A T O R Y A Monthly Alert to Regulations Affecting the Medical Device and Diagnostic Industries MONITOR In This Issue Volume 22, Number 3 March 2014
Transcript
China Adopts Reforms to Medical Device Regulations, Finalizes Fast-Track Program
China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing.
Officials have yet to release details of the bill, but AdvaMed, which has consulted with the China Food and Drug Administra-tion on the reforms, says the revisions will be positive. “We’re expecting a lot of approaches to be modernized or strengthened,” Elise Owen, associate vice president of global strategy and analy-sis at the trade group, tells IMDRM.
“Most of the regulations we comply with as an industry in China are going to be updated or renewed,” Owens says, noting a recent uptick in CFDA guidelines.
Given the expected scope of the overhaul, AdvaMed is pressing the agency for a longer public comment period and more appropriate transition timelines. “We’re looking for six months as opposed to 30 or zero days,” Owens says, noting the CFDA has provided 60 days for comment and six months to comply with other recent requirements.
“Everything is changing,” Owens warns. “It’s more impor-tant to be focused on China than ever, because [the fact that] it’s this way today doesn’t mean it’ll be that way tomorrow.” In antic-ipation of the new law, a lot of regulations are being replaced and that will only intensify, she adds.
Fast-Track Opened to Foreigners
Also last month, the CFDA finalized regulations on fast-track approvals and device reregistration (IMDRM, May 2013). The final versions open both programs to foreign manufacturers — a shift from the drafts, which were limited to Chinese companies.
Beyond that, and some confusion regarding patents, the final regulations are largely unchanged, Owens says. “There are still some unanswered questions. But we’ve reached out to CFDA and, so far, we’re seeing their willingness to engage and interact with our members to clear areas of misunderstanding.”
Another positive step was a December decree implementing provisions for the CFDA’s legislative process, Owens notes. Not
China Adopts Reforms to Medical Device Regulations, Finalizes Fast-Track Program ......... 1
Odds of Seeing EU Device Regs Finalized Before May Elections Increasingly Slim ............... 2
U.S. FDA’s Hamburg Says India Trip Helped Sync Countries’ Goals ....................... 3
India Discloses Sponsor Payouts For Trial-Related Deaths ........................................ 3
Devicemakers Urged to Prepare Now For Mandatory eMDRs in U.S. in 2015 ................. 3
Devices-Only Enforcement Unit Needed To Handle Increasingly Complex Products .......... 4
U.S. FDA Issues Final Guidance On PMA/PDP Pre-Sub Program ........................... 5
U.S. Won’t Expand 510(k) Modification Policy, Sticks With 1997 Guidance ........................ 5
Russian Regulator Requires New Tests For Device Conformity Assessments ..................... 7
PMA Yearly Reports Should Include Reasons for Device Changes: U.S. FDA ................ 7
UK Gives Devicemakers Clearer Guidance on Borderline Products ......................... 8
Industry Q&A Guidance Attempts To Demystify RoHS 2 Rules ................................... 9
In Brief ................................................................... 10
Editor’s Note: The International Medical Device Regulatory Monitor is available in an electronic edition, which includes web access to seven years of archived issues. For information on convert- ing to an electronic subscription, contact us at (888) 838-5578.
INTERNATIONAL MEDICAL DEVICE REGULATORY
A Monthly Alert to RegulationsAffecting the Medical Device
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR March 2014Page 2
specific to medical devices, it covers all CFDA regu-latory activities and discusses how regulations will be developed.
Among other issues, the decree outlines a more robust process for ensuring that requirements are consis-tent with international practice, Owens says. For exam-ple, the provisions include taking stakeholder comments into account and notifying the World Health Organiza-tion of requirements, where appropriate. “We saw a lot of best practice quantified into CFDA policy last year,” she says. — Nick Otto
Odds of Seeing EU Device Regs Finalized Before May Elections Increasingly Slim
It appears highly likely that the European Parlia-ment won’t finalize the proposed medical device and IVD regulations before May elections, a lawyer familiar with the legislation says.
The process for passing the regulations, which will replace the current medical device directives, is about two-thirds complete at this point, said Erik Vollebregt, with Axon Lawyers in the Netherlands. But the revised regulations still need to be finalized before the laws can go into force, and no deadline has been set on the final-ization process. Disagreements among members of Par-liament have delayed action to the point that it’s now pushing up against elections scheduled for May 22-25 throughout EU member states.
“If the Council sits on its hands or keeps disagree-ing with each other until the elections, then the rules will just stay the way they are,” Vollebregt told IMDRM
following a Feb. 19 Regulatory Affairs Professionals Society webinar at which he spoke. The most prominent outstanding disagreements are over how centralized the PMA procedure should be and reprocessing provisions.
During a December meeting to discuss points of contention, member states maintained extreme politi-cal positions. Some seemed on the verge of pulling their support, with the Netherlands saying the suggested PMA procedure would not achieve safety goals and UK representatives preferring to delay the regulation rather than adopt a flawed approach (IMDRM, January).
If the regulations are adopted before the elections, Vollebregt expects the reprocessing rules will be left out. Dagmar Roth-Behrendt, the rapporteur for the device regulation, has taken the position that the only reason to make single-use devices instead of ones that can be reprocessed is greed among devicemakers, he explained. “You can think about that logic all you want. It’s likely not the most rational point of view, but it’s what we have,” he said. If reprocessing is left out of the regulation, decisions on the practice would be made by individual member states.
If nothing passes before elections, the new Parlia-ment is expected to put the project back on the legisla-tive agenda where it will be taken up by a new rappor-teur. Vollebregt noted that the regulations would likely be edited to reflect new priorities — for example, the current Parliament, including Roth-Behrendt, is very much in favor of centralized government and device reprocessing, which won’t necessarily be true of the next crop of lawmakers.
Prepare for Compliance Now
Another key issue is the use of special notified bod-ies for high-risk devices, Vollebregt said. The European Commission still needs to establish a system for regis-tering and authorizing SNBs and develop procedures for sharing SNB-generated information with national authorities and publishing assessment reports.
And what if the regulations are adopted largely as written? Vollebregt says the biggest impact would be on IVD manufacturers. That’s because, as defined, a diagnostic requiring notified body approval could con-ceivably include any device or software with even an indirect medical purpose — including mobile apps that simply recommend lifestyle changes for better health. As many as 90 percent of tests would fall into this cat-egory, he said.
Document Index
The following documents covered in this issue of the Interna-tional Medical Device Regulatory Monitor are available for download at www.fdanews.com/IMDRMdocs.
U.S. FDA eMDR Guidance
Final Rule on MDR Electronic Submission Requirements
U.S. FDA Memo Detailing Agency Reorganization
U.S. FDA Final Guidance on Presubmission Program
Report on Modifications to U.S. 510(k) Process
U.S. FDA Draft Guidance on Annual Reports for Approved PMA Applications
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITORMarch 2014 Page 3
Vollebregt recommends that devicemakers begin reviewing their technical documentation now for com-pliance with the proposed regulations — a potentially expensive and lengthy undertaking. And companies should work with their notified bodies to identify “crucial suppliers,” as the language in the legislation is unclear.
Vollebregt also advises companies to be prepared for more unannounced inspections by notified bod-ies, noting that refusing to allow an audit could result in suspension of products in the market. “A competitor of yours might call your notified body and say, ‘Hey, come look in this production factory, because I know some things are really, really wrong here,’” he said. — Elizabeth Orr
U.S. FDA’s Hamburg Says India Trip Helped Sync Countries’ Goals
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products.
On the trip, Hamburg said she stressed the message that weak quality standards equate directly with harm to patients. “I’m happy to report my counterparts in India supported this view,” she told reporters on a conference call to summarize highlights of her trip.
The trip included the signing of a five-year accord with India’s Ministry of Health and Family Welfare that allows the two authorities to share information from quality inspections of manufacturing plants, clin-ical trial sites and testing laboratories. The agreement also allows the FDA to station additional investigators in the country.
The true test of India’s commitment to quality will come later this year when a major FDA review of the efficacy and bioequivalence of generic drugs gets under-way, one observer believes.
Roger Bate, an American Enterprise Institute econ-omist and specialist on counterfeits, says Hamburg’s visit highlighted both the big political picture and more detailed concerns. The FDA’s generic drug study “will lead to … more investigation and more pinpointing of the problems that are coming out of India,” Bate says. “We need a better evidence base.”
Hamburg, who has twice visited China, hinted at additional overseas trips in the future. “I think this greater engagement is an important, if not essential, part of my job as commissioner,” she said. — Nick Otto
India Discloses Sponsor Payouts For Trial-Related Deaths
India’s Ministry of Health and Family Welfare has begun publishing data about compensation paid in clini-cal trial-related deaths, with the first wave of data cover-ing 2010 into 2013.
The largest payout — about US $25,777 — involved a death in a trial of the Xience Prime stent system, a device sponsored by Fortis Escorts Heart Institute in New Delhi. The majority of payouts, totaling about $866,905 over four years, related to drug trials.
The report provides the name of the trial sponsor, the investigational product associated with a serious adverse event leading to death and the amount of com-pensation the government paid.
One industry observer questioned the validity of some of the claims from 2010 and 2011, saying sponsors and CROs only made payments under the threat of hav-ing their licenses to conduct trials in the country revoked. It wasn’t until 2012 that the Central Drugs Standard Con-trol Organization issued a draft guideline on clinical trial death and injury compensation. The guideline would have required sponsors to provide free medical care as long as needed in the case of an injury. In response, the U.S. National Institutes of Health announced it was pulling out of clinical trials in India (IMDRM, August 2013).
The government has since scaled back the require-ments, announcing last August that it would eliminate mandated compensation for study subjects who receive no therapeutic benefit from a trial. But the requirements regarding subjects injured in trials remain unchanged (IMDRM, September 2013).
In January, CDSCO issued an interim formula for determining trial compensation, factoring in the patient’s age and health. The base payout is about $19,000 (IMDRM, February). In cases of death where a patient had a 90 per-cent expected mortality rate within the 30-day period, com-pensation is a fixed amount of roughly $3,200. — Nick Otto
Devicemakers Urged to Prepare Now For Mandatory eMDRs in U.S. in 2015
Devicemakers should take steps now to secure a pro-duction account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. The U.S. Food and Drug Admin-istration set the deadline in a final rule issued Feb. 14, along with Q&A guidance aimed at easing the transition.
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR March 2014Page 4
eMDRs have been available since 2008, and the Feb. 14 final rule appears to largely follow an eMDR draft rule issued in the summer of 2009. At the time, industry expressed concerns that electronic submissions would be unreliable as well as costly (IMDRM, December 2009).
In providing guidance on the rule, the FDA emphasizes that eMDRs include the same information as paper MDRs. To begin submitting eMDRs, a manufacturer needs to:
● Request a Web Trader account from the FDA’s Electronic Submissions Gateway;
● Submit a Letter of Non-Repudiation to the agency; ● Obtain a personal digital certificate; and ● Submit a mock report as test data.
The FDA will issue a production account if the test is successful, after which eMDRs may be submitted.
Devicemakers have two choices for preparing eMDRs. One option is the FDA’s free eSubmitter soft-ware, by which manufacturers can manually enter case data for transmission to the agency. The other option is Health Level Seven (HL7) Individual Case Safety Reporting, which allows for batch report preparations.
But unlike eSubmitter, HL7 does not permit users to print the report. Because of this, “entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs,” the guidance says.
“The time zone should not be a concern for timely reporting under MDR,” the guidance states, noting the date in the submitter’s time zone is used to deter-mine whether an MDR arrived on time. This holds even though the system displays times in the U.S. eastern time zone, where the FDA is located.
The guidance cautions that the uploading process may generate an error if not all required data is pro-vided, an invalid report number is used, there are too many characters in a given data field, or the report duplicates one already in the database.
User facilities are encouraged to submit eMDRs, but may still submit paper MDRs “because of concerns over the cost of implementation for user facilities, and the relatively low volume of reports FDA receives from such facilities,’ the guidance adds.
View the eMDR guidance at www.fdanews.com/ext/resources/files/02/02-17-14-QandA.pdf. The final rule is at www.fdanews.com/ext/resources/files/02/02-17-14-MDRs.pdf. — Elizabeth Orr
Devices-Only Enforcement Unit Needed To Handle Increasingly Complex Products
Citing the growing complexity of medical devices, the U.S. Food and Drug Administration says it will create a devices-only enforcement unit with subspe-cialists, where necessary, “to carry out effective over-sight” of manufacturers.
The goal: more consistent inspections and enforce-ment decisions with fewer bureaucratic hurdles for investigators to issue warning letters.
Under a reorganization announced last month, the FDA will create specialized teams who will organize regulatory and compliance programs. The agency will also streamline its internal review process for approving enforcement actions.
Commissioner Margaret Hamburg detailed the plan in a memo to agency staff, and FDA officials emphasized to IMDRM that the move is not aimed at cutting costs across the agency. Rather, the FDA hopes the reorganiza-tion will allow it to respond more quickly to public health threats and target inspection resources more efficiently.
FDA spokesman Stephen King said all agency investigators, compliance officers, import reviewers, laboratory personnel and managers “will begin a transi-tion to become more specialized in a particular regula-tory program area.”
The agency’s 26 global districts will remain in place, but their organizational structure will change, King said. He declined to elaborate. Meanwhile, the Office of Regulatory Affairs’ structure will become more closely aligned with the various centers.
Howard Sklamberg, deputy director for global regula-tions, said the reorganization shouldn’t affect the number of warning letters issued, but it will remove bureaucratic lay-ers from the process of determining which violations to pursue. It also will result in investigators who are qualified to deal with increasingly complex products.
The goal is to “heighten the technical expertise throughout the agency, increase and improve communi-cations internally [and] make it easier for folks to inter-act with us,” Sklamberg said at a recent meeting of the Alliance for a Stronger FDA in Washington, D.C.
The next step is for each center director to create a detailed action plan for the reorganization. The plans should be finalized by Oct. 1, the memo says.
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITORMarch 2014 Page 5
To read the memo, visit www.fdanews.com/ext/resour ces/files/02/02-04-14-HamburgMemo.pdf. — Robert King
U.S. FDA Issues Final Guidance On PMA/PDP Pre-Sub Program
Devicemakers planning a premarket approval applica-tion or product development protocol should take advantage of presubmission meetings with the U.S. Food and Drug Administration to pin down exactly what data the agency expects to support safety and efficacy of a new product.
In a Feb. 21 guidance on its presubmission program, the agency urged devicemakers to submit clinical study risk-determination requests in advance of making sub-missions. The requests, the FDA says, cost no money and do not obligate sponsors to submit an IDE, but can smooth the path to approval considerably.
When a request is received, the FDA will send the sponsor an acknowledgement letter with a Q-Sub num-ber to be used on future communications regarding the submission. Once the agency decides, it will send the sponsor a letter stating that the study is exempt or con-sidered a significant or nonsignificant risk. This deter-mination is final, the guidance says.
Determination vs. Agreement Meetings
The guidance also discusses formal early collabora-tion meetings with the FDA, which can take the form of a determination or an agreement meeting.
Devicemakers that expect to submit a PMA or prod-uct development protocol can use a determination meet-ing to get a binding decision on the type of scientific evidence needed to show safety and efficacy.
An agreement meeting is used by companies planning to submit a Class III device to set the parameters, such as clinical protocol, of the investigational plan. These agree-ments are also binding unless the sponsor changes major elements, such as intended use or product design.
The final guidance, issued Feb. 18, supersedes Pre-IDE Program: Issues and Answers - Blue Book Memo D99 - 1, from March 25, 1999. A draft version of the guidance was issued in July 2012 with the aim of expanding the program to a broad range of applica-tions — from IDEs, PMAs and 510(k)s to humanitarian device exemptions, de novo filings and more.
The final guidance provides recommendations on information to include in a presubmission package and
the most useful times to seek a meeting. Requests for presubmission meetings will be reviewed within 14 cal-endar days and meetings scheduled within 75 days in most cases, the FDA says, adding that no meetings will be scheduled more than 90 days out.
Sponsors can also use presubmission meetings to dis-cuss deficiencies and other issues identified during pre-market review of an application. The guidance sheds light on how the agency will provide feedback in these cases.
The guidance is available at www.fdanews.com/ext/resources/files/02/02-18-14-Guidance.pdf. — April Hollis
U.S. Won’t Expand 510(k) Modification Policy, Sticks With 1997 Guidance
Medtech companies that make modest improve-ments to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Adminis-tration, a Feb. 25 report to Congress says.
In publishing the report, the agency formally closes the door on an unpopular plan to expand the kinds of changes that would trigger a new 510(k).
During negotiations on the 2012 FDA Safety and Innovation Act, Congress ordered the FDA to withdraw a 2011 draft guidance, seek stakeholder input and issue a report before moving forward with any changes to the 510(k) process. After a thorough review, the agency concluded that the 1997 guidance currently in use pro-vides a “solid foundation” for 510(k) policy and “should remain largely unchanged,” the report says.
While endorsing the 1997 guidance, the FDA says minor tweaks may be needed “to ensure clarity and con-sistency of interpretation.” These include clarification of certain terms and the role of quality systems in 510(k) clearance, and updated flowcharts on when a new 510(k) is required. Industry had complained that the 2011 draft guidance no longer included flow charts, making it harder for companies to make that determination.
The FDA will issue separate guidance on changes to software, which is often upgraded too rapidly for the traditional model to apply, the report says. Officials had alluded to such plans earlier this fall. Other device-spe-cific guidance may be issued as needed, the report adds.
Janet Trunzo, senior executive vice president of tech-nology and regulatory affairs at AdvaMed, welcomed the decision to build on the 1997 guidance rather than create a new regulatory framework, and to retain the flow charts.
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“While we are still reviewing all the details of the report, AdvaMed commends the FDA for listening to our views and for the agency’s willingness to incorpo-rate many of our recommendations in the future 510(k) modifications guidance,” she said.
View the report at www.fdanews.com/ext/resources/files/03/03-03-14-report.pdf. — Elizabeth Orr
Russian Regulator Requires New Tests For Device Conformity Assessments
Russian officials have issued new procedures for conformity assessment of medical devices, spelling out requirements for technical and toxicological testing and clinical studies. A successful conformity assessment is key to registering a product in the market there.
According to the Ministry of Health and Social Devel-opment, conformity assessment will include an analysis of data and literature related to safety, operational and design characteristics of the product and an inspection of the man-ufacturing plant. Technical testing should be performed on samples of the device with any accessories required when using it for its intended purpose, the ministry says.
Copies of preliminary tests of the device and tests results from outside the Russian Federation should be submitted, if available. Companies should also provide documentation on risk analysis and on the clinical use of the device.
If the originals of any documents are in a foreign language, these must be presented along with a certified Russian translation. Technical testing of devices must be conducted within 30 working days from the date of applying for registration.
Rules for Trial Sites
The document provides separate procedures for the conformity assessment of in vitro diagnostic devices. The new procedures implement requirements in recent Russian legislation and regulations.
The conformity assessment provisions should be welcomed by industry, which has complained of a lack of guidance on registering devices in Russia. Without such guidance, the pace of registrations has ground to a near halt, sources say (IMDRM, February).
Separately, Roszdravnadzor published new rules for medical centers seeking permission to conduct clinical trials of devices in Russia.
The rules, which took effect Feb. 25, require sites to include the following with their applications:
● A medical facility operating license and evi-dence the center is capable of performing the trial being requested;
● The organization’s charter; ● Information about intensive care units, if the
trial involves a high-risk device (Class IIb and Class III); and
● The site’s patient privacy policy. — Nick Otto
PMA Yearly Reports Should Include Reasons for Device Changes: U.S. FDA
Devicemakers should note whether changes to pre-market approval devices were due to enhancement, product complaints or adverse events when preparing their annual reports to the U.S. Food and Drug Admin-istration, according to guidance issued Feb. 10.
Providing the rationale behind modifications “will give FDA a more complete picture of the postmarket safety profile of the device,” the agency says.
Annual reports on PMAs should note all changes made to the device in the past year, including PMA sup-plements that were submitted and the date approved, if applicable, the guidance notes. It finalizes draft guid-ance issued in October 2006.
Issued jointly by the Center for Devices and Radio-logical Health and the Center for Biologics Evalua-tion and Research, the guidance aims to ensure annual reports for PMAs are complete and the centers’ actions are concordant.
The agency suggests that companies provide sep-arate tables for manufacturing, design and labeling changes and identify any links between categories. The company should note why the change doesn’t affect safety and efficacy, but does not need to provide verifi-cation and validation data in the annual report, the guid-ance says.
The change order number or other unique way of iden-tifying the change should be included with each table.
Reports should also include information on the number of devices shipped or sold during the report-ing period, to help the FDA assess the product’s public health impact, the guidance says. “For device implants, data regarding the number of devices actually implanted should be provided, if it is available,” it adds.
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR March 2014Page 8
In addition to detailing what devicemakers should include in annual reports, the guidance discusses steps FDA staff take in reviewing reports and actions — e.g., request for additional information — they may recom-mend to manufacturers.
Comments may be submitted at any time to docket no. FDA-2006-D-0039. View the guidance at www.fdanews.com/ext/resources/files/02/02-10-14-PMAann ualrpts.pdf. — Meg Bryant
UK Gives Devicemakers Clearer Guidance on Borderline Products
Citing continuing confusion among devicemakers regard-ing borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clar-ifying when they qualify as a medical device in the EU.
The Feb. 5 guidance stresses that medical devices must have a medical purpose and function primarily in a way that is not metabolic, immunological or pharmaco-logical. The medical purpose is generally defined in the product labeling, instructions for use and promotional materials, the guidance says.
Manufacturers should consider whether there is a direct link between the corrective function of the device
and the individual concerned, the MHRA says. For exam-ple, breast pumps typically aren’t considered to be medi-cal devices. But breast pumps that treat inverted nipples are devices because there is a specific primary intended medical purpose. The determining factor is the mode of action of the product concerned, the agency says.
Daily living aids also fall into the gray zone, the guidance notes. Products with a medical purpose and clear corrective action — such as hearing aids and external limb prostheses — are medical devices, while grab rails and toilet seats are not. Most sports products and personal protective gear, such as eye-protecting visors with no corrective function, also fall outside the definition of medical device.
The agency adds, however, that the 2007 amendments to the device directive contained provisions for products intended both for medical and personal use. “In such cases the product should be CE marked as a medical device. However, the manufacturer must also fulfil the relevant basic health and safety requirements of Directive 89/686/EC on personal protective equipment,” the guidance says.
The current definition of a medical device includes standalone software that is used in conjunction with a device for diagnostic or therapeutic purposes. Examples
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include software to enhance X-ray or ultrasound images and telecare alarm systems, the MHRA notes.
The software issue is one that regulators have been struggling with everywhere, as more devices incorpo-rate a software component. In December, the Interna-tional Medical Device Regulators Forum issued final guidance on harmonized definitions of software as a medical device (IMDRM, January).
View the guidance at www.fdanews.com/ext/resources/files/03/03-14-MHRA.pdf. — Nick Otto
MHRA: Adverse Incident Reports Increased 23.4 Percent in 2012
Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-gener-ated reports, the agency says.
The percentage of companies submitting via the Manufacturers Online Reporting Environment increased only slightly from the previous year, but the agency expects that to change. “It is anticipated that the con-tinued development of MORE, the use of XML, and the introduction of PDF forms with XML format data extraction capabilities will prompt considerable growth in this area,” the MHRA says.
Overall, the MHRA received 13,549 adverse inci-dent reports, up 23.4 percent from 10,984 in 2011. The number of periodic summary reports grew from 106 to 130 over the same period, a summary of 2011 and 2012 data shows. At the same time, the number of individual incidents reported within PSRs, including from clinical trials, dropped to 6,502 in 2012, from 10,745 the previ-ous year.
Just over 2 percent (303) of reports in 2012 involved a fatality. By contrast, a third (4,495) of all reports involved a serious injury, including implant or pace-maker revision, the MHRA notes. The agency con-ducted its own investigation into 2,001 of the reports, the report says.
Material and mechanical problems were responsible for the overwhelming majority of reported events, with more than 2,500 reports in each of those categories, fol-lowed by output issues with about 1,300 reports. Incom-patibility, electrical/electronic, infusion/flow, user error and activation/positioning/separation each accounted for more than 500 reports.
The MHRA says data from 2013 will be added once a review is complete, adding future reports will reflect changes in adverse event handling processes and enhanced trend analysis. “The parallel introduction of new adverse incident data management tools will also allow us to publish updated core data more frequently,” the agency says.
Starting in 2011, the MHRA adopted a new risk-assessment and triage system to analyze and act on items according to risk. Last fall, the agency announced plans to streamline adverse event reporting by folding five reporting systems into one (IMDRM, October 2013).
View the report at www.fdanews.com/ext/resources/files/02/02-12-14-mhra-adverseincidents.pdf. — Meg Bryant
Industry Q&A Guidance Attempts To Demystify RoHS 2 Rules
Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. That designa-tion is determined by customs regulations.
Products produced for exportation only are not considered “placed on the market” and not required to comply, the guidance says. It was released jointly by COCIR, Eucomed and Edma.
The Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, or RoHS 2, comes into effect this July 22 for all CE-marked electronic medical devices and active implant-able medical devices and on July 22, 2016, for in vitro diagnostics. It requires manufacturers of EEE devices to submit technical documentation and a declaration of conformity and apply CE marks to finished products.
RoHS 2 only applies to finished electronic equip-ment, meaning components, spare parts and unfinished products are exempt from the requirements, the guid-ance notes. However, parts that are destined to later be installed in a CE-marked electrical device will need to comply with the directive.
EEE devices currently on the market have until July 22, 2019 to become RoHS 2-compliant.
The directive has created some confusion among devicemakers regarding their conformity assessment obligations under RoHS 2 and those required to satisfy
INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR March 2014Page 10
the requirements of the medical device directives. Eucomed published an earlier guidance last summer focusing on the conformity assessment requirements (IMDRM, July 2013).
A customs procedure known as “inward processing” allows materials to be processed for re-export within the European Economic Community by community man-ufacturers without the need to pay customs duties and value added taxes, the trade groups note. The guidance recommends that devicemakers check with the Euro-pean Commission’s Blue Guide if they have questions about their responsibilities under RoHS 2. Revisions to the guide, expected later this year, should provide addi-tional clarification on the directive.
According to the directive, manufacturers of prod-ucts that are subject to the directive but are not com-pliant should take necessary steps to bring the device into conformity or withdraw or recall it, the guidance clarifies.
“Manufacturers must also keep a register of noncon-forming EEE and product recalls, and keep distributors informed,” the guidance says, adding the same obliga-tions apply to importers. “Distributors must ensure cor-rective actions are taken but are not required to keep a registry of nonconforming EEE.”
The guidance also addresses suppliers, saying dec-larations of conformity should cover a “specific mate-rial, part and/or subassembly, or a specific range of materials, parts and/or subassemblies.” Supplier decla-rations should also note whether exemptions were used to determine compliance with RoHS 2 requirements, and which ones.
The groups plans further guidance on RoHS 2 this month. View the FAQ guidance at www.fdanews.com/ext/resources/files/03/03-14-ROHS.pdf. — Nick Otto
MHRA Names Clinical ChiefThe UK’s Medicines and Healthcare products Regu-
latory Agency has tapped Neil McGuire to be clinical director of medical devices, effective March 3. McGuire previously worked for the Royal Air Force Medical Ser-vice and the Defence Medical Services as a consul-tant adviser in anesthesia, pain medication and critical care. “His clinical expertise and experience will be vital in our role of safeguarding public health and ensuring medical devices are fit for purpose,” said the MHRA’s medical devices chief John Wilkinson.
TGA Official Joins Industry GroupGovernment’s loss is industry’s gain. The Medical
Technology Association of Australia has named former Therapeutic Goods Administration officer Gary Burgess to be director of regulatory affairs. At the TGA, Bur-gess served as a section director in the Office of Device Authorisation, where he was responsible for process-ing medical device applications for entry onto the Aus-tralian Register of Therapeutic Goods and assessing applications for conformity assessment certificates. He assumes his MTAA post on March 17.
MTAA Defends Prosthetics PricingThe Medical Technology Association of Austra-
lia is urging an “informed debate” on reimbursement for surgically implanted prostheses like hips and knees after the country’s leading association of private health insurers called for price reductions. “Government over-sight of prostheses reimbursement has frozen pricing to 2005 levels with no increases on line items, which is in stark contrast to the yearly premium increases of pri-vate health insurance funds,” MTAA Chief Executive Susi Tegen said. Tegen attributed the rise in premiums to growing demand by an aging but active population, not pricing.
Reporters: Elizabeth Orr, Ferdous Al-Faruque, Lena Freund, Robert King
President: Cynthia Carter; Content Director: Dan Landrigan; Executive Editor: Meg Bryant
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