08.31.10
FDA Drafts Strategy to Improve 510(k) Process
Capping a year-long process wracked by controversy, criticism and concern, the U.S. Food and Drug Administration (FDA) has created a preliminary but detailed plan to better regulate the nation’s medical device industry.
A 172-page report released Aug. 4 contains recommendations to help the agency achieve three main objectives: foster device innovation, create a predictable regulatory environment, and enhance device safety. The recommendations contained in the FDA’s report were driven by an internal reassessment of the agency’s premarket review process, otherwise known as the 510(k) program. Last year, the program was criticized by public health advocates and lawmakers as well as scientists at the Center for Devices and Radiological Health (CDRH), who claimed they were pressured to approve certain products.
The FDA uses the 510(k) program to grant approval to medical devices that are deemed similar to products already on the market. Manufacturers are partial to the program because it often provides them with a cheaper, faster path to market approval. In recent years, concerns have been raised about the 510(k) process, specifically whether it allows medical devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency and transparency hinders device development.
Last year’s criticism about the device approval process led the FDA to create two panels to review the 510(k) program and recommend changes. The recommendations from those panels—the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making—are the result of input from public meetings, open dockets, data analyses and input from CDRH staff.
The preliminary reports are available for public comment and review at www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm. Once the CDRH has assessed public input, it will announce which recommendations it will adopt, along with projected timelines for doing so, according to a news release from the FDA.
Some of the key recommendations and the public health objectives the report addresses include:
Fostering Device Innovation
• The 510(k) report recommends major improvements to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k) but do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process—called the de novo classification process. The recommendations include streamlining the process and clarifying CDRH’s expectations for submissions that undergo this type of review.
• The science report recommends that CDRH make better use of scientific experts outside of the agency by developing a web-based network of external experts using social media technology. This network would help CDRH staff leverage outside knowledge without serving in an advisory capacity.
Enhancing Regulatory Predictability
• The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance document would help clarify the kind of information that should be included in 510(k) submissions so companies can plan accordingly. This would help the center’s review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time-consuming follow-up requests for information.
• The science report recommends use of a standardized “Notice to Industry” letter that would generally be issued as a “Level 1—Immediately in Effect” guidance document to quickly communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. These letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH’s expectations with respect to a particular group of devices.
Improving Patient Safety
• The 510(k) report recommends that CDRH consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know about the safety and effectiveness of the device under review. This currently is not required; as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff to more efficiently make decisions and potentially avoid extensive follow-up inquiries.
• The 510(k) report recommends that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. The report also suggests the center create a regulation that would clarify the circumstances under which the center would rescind 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate and consider whether additional authority is needed.
• Both reports recommend that CDRH build upon public databases to include meaningful, up-to-date information that supports good decision making and promotes the safe use of devices. This could be accomplished by improving the current 510(k) database by including summaries of FDA review decisions, current labeling and photos. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on device regulations.
PearlDiver Creates Medical Information Website
Five numbers.
That is all it takes to unleash an avalanche of data about Warsaw Health System LLC-Kosciusko Community Hospital in Warsaw, Ind. Data such as the average Medicare charge ($17,655) and average Medicare reimbursement ($5,119) as well as the top 10 Medicare procedures performed there (total knee arthroscopy, partial hip replacement and hip resurfacing are among the more popular surgeries).
Such data are just a fraction of the free pieces of information that can be found on a new website, www.pearldiverinc.com. The site was launched by Fort Wayne, Ind.-based PearlDiver Technologies Inc., which provides data and analysis to medical device manufacturers and healthcare providers.
The data is based on 1.1 billion Health Insurance Portability and Accountability Act-compliant patient records and includes information on more than 6,000 healthcare providers. PearlDiver executives hope the site will act as a resource that helps patients, device manufacturers and healthcare providers cost-effectively resolve their medical problems.
“We really think that, in general in the United States, we are entering a new era of healthcare where information is going to be more important than in the past. Where payers are trying to push decision-making down to the patient level,” PearlDiver CEO Robin R. Young told Greater Fort Wayne Business Weekly. “Manufacturers are also being asked by regulators to justify the cost of their products within the context of patient outcomes. And hospitals need a lot of data to become more cost-effective without reducing care levels. It’s a delicate balance, and so hospitals are looking for more performance data, outcome data, that sort of thing.”
PearlDiver’s database is the nation’s largest, according to Young. Its size, he noted, allows the company to aggregate a wide variety of information in five areas on the site:
• Hospital Lookup provides visitors with key procedural, revenue and other data for more than 6,000 healthcare providers;
• Procedure Lookup provides information about medical procedures and diagnoses by specific medical codes;
• Data Guys Market Research provides detailed information on PearlDiver’s market reports, both standard and custom;
• Consumers Choice Health Savings Tool (not yet available) will enable users to compare the cost of any procedure performed at U.S. hospitals or clinics, which essentially will give prospective patients the opportunity to shop for services. The tool also will allow people to compare healthcare providers based on about 50 measurements of quality, including infection and mortality rates, wait times in hospital emergency rooms and patient ratings. As of press time, the tool was being readied for a September launch.
• Sales Territory (not yet available) will be an interface that gives salespeople calling on healthcare providers information to help them better understand a provider’s buying habits. This paid feature is expected to be available in January 2011.
Visitors to the website can access information contained in the database by entering the name of a hospital, a zip code, a procedure or a specific billing code.
PearlDiver currently is considering offering customized health savings tools to companies that would pay a small fee for the service. Other health savings data would remain free to the general public.
Formed in late 2006, PearlDiver provides data and analyses to medical device manufacturers. The company has offices in Colorado Springs, Colo., and Philadelphia, Pa.
Accutek Moving to Larger Facility
Accutek Testing Laboratory is tripling its space and adding 20 jobs as it expands into Fairfield, Ohio.
The materials testing firm in early August finalized the $1.5 million purchase of a 50,000-square-foot facility on Port Union Road. The company is using loans from the Ohio Department of Development and U.S. Small Business Administration to finance the project, according to a news release.
Renovation is underway for the company’s anticipated move at the end of September, when the lease ends on its facility in West Chester Township, Ohio. The new facility will enable the firm to meet growth targets for sales and hiring over the next five years, and gives employees more space in which to work.
“We’re jam packed in here like sardines,” President John McCloy told the Hamilton Journal-News of Hamilton, Ohio.
Unit Building Services of Cincinnati is performing such renovations as removing walls for more collaborative space and adapting warehouse space for a laboratory. The company is spending $300,000 on renovations and new equipment, McCloy said.
“Accutek’s focus is finding better ways to support our customers in their design and development projects,” McCloy said. “The purchase and renovation of this facility will position Accutek for expansion of in-house testing capacity with enhanced capabilities.”
McCloy bought Accutek in 2003. The company tests products manufactured for the aerospace, medical and manufacturing industries worldwide.
Accutek has less than 50 employees.
Orchid Expands Capabilities at Satellite Facility
Orchid Orthopedic Solutions LLC is adding cleaning and packaging capabilities to its coating facility in Michigan.
Company bigwigs said the expanded capabilities will enable the firm to “stay ahead of the curve” in validation. “We are excited to expand this capability and streamline the process for our customers,” said Matt Burba, Orchid’s executive vice president. “We are able to take a product from concept all the way through delivery, and this will add value to the manufacturing process.”
Executives appointed Wanda Colon-Rivera as packaging manager, but it is not clear whether her responsibilities are limited to the bio-coating facility in Southfield, Mich., or if she is in charge of packaging operations for the entire company. In her previous positions, Colon-Rivera managed several aspects of new product development, including product design validation and verification, clinical trials, packaging validations, process validations, and quality and regulatory requirements, including labeling.
Orchid’s Bio-Coat facility specializes in hydroxylapatite, titanium plasma spray and resorbable blast media surface treatments. The plant is registered with the U.S. Food and Drug Administration and has achieved ISO 13485:2003 certification.
Orchid Orthopedic Solutions designs and manufactures implants, instruments, and innovative technologies for the orthopedic, dental and cardiovascular markets. The company is based in Holt, Mich.
RevZero Expands its Manufacturing Capacity
Strong growth during the first half of 2010 has prompted RevZero Inc. to expand its multi-axis milling capabilities.
The 3-year-old precision machining and contract manufacturing firm has added a new vertical machining center, according to a news release. Executives did not provide details of the new machining center; they focused instead on the company’s 60 percent growth rate this year and its outlook for the remainder
of 2010.
“We expect strong growth and additional equipment purchases to continue for the rest of the year and into 2011,” said Eric Grenier, RevZero’s president.
Tom Weiss, the company’s vice president of sales, attributed the firm’s robust growth to its focus on customer service.
“We provide our customers the best in prototyping to full production capabilities for micro-precision metal and plastic components, sub-components and assemblies,” he said in the news release. “This growth is the result of our ability to provide customers with ultra-responsive services in all areas of our business, from answering the phones and providing quotes to final documentation and shipment.”
Based in Chanhassen, Minn. (a city located 16 miles southwest of Minneapolis), RevZero performs precision-machining services with the Swiss-type screw machines, conventional CNC (computed numerically controlled) machines and EDM wire technology.
Capping a year-long process wracked by controversy, criticism and concern, the U.S. Food and Drug Administration (FDA) has created a preliminary but detailed plan to better regulate the nation’s medical device industry.
A 172-page report released Aug. 4 contains recommendations to help the agency achieve three main objectives: foster device innovation, create a predictable regulatory environment, and enhance device safety. The recommendations contained in the FDA’s report were driven by an internal reassessment of the agency’s premarket review process, otherwise known as the 510(k) program. Last year, the program was criticized by public health advocates and lawmakers as well as scientists at the Center for Devices and Radiological Health (CDRH), who claimed they were pressured to approve certain products.
The FDA uses the 510(k) program to grant approval to medical devices that are deemed similar to products already on the market. Manufacturers are partial to the program because it often provides them with a cheaper, faster path to market approval. In recent years, concerns have been raised about the 510(k) process, specifically whether it allows medical devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency and transparency hinders device development.
Last year’s criticism about the device approval process led the FDA to create two panels to review the 510(k) program and recommend changes. The recommendations from those panels—the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making—are the result of input from public meetings, open dockets, data analyses and input from CDRH staff.
The preliminary reports are available for public comment and review at www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm. Once the CDRH has assessed public input, it will announce which recommendations it will adopt, along with projected timelines for doing so, according to a news release from the FDA.
Some of the key recommendations and the public health objectives the report addresses include:
Fostering Device Innovation
• The 510(k) report recommends major improvements to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k) but do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process—called the de novo classification process. The recommendations include streamlining the process and clarifying CDRH’s expectations for submissions that undergo this type of review.
• The science report recommends that CDRH make better use of scientific experts outside of the agency by developing a web-based network of external experts using social media technology. This network would help CDRH staff leverage outside knowledge without serving in an advisory capacity.
Enhancing Regulatory Predictability
• The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance document would help clarify the kind of information that should be included in 510(k) submissions so companies can plan accordingly. This would help the center’s review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time-consuming follow-up requests for information.
• The science report recommends use of a standardized “Notice to Industry” letter that would generally be issued as a “Level 1—Immediately in Effect” guidance document to quickly communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. These letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH’s expectations with respect to a particular group of devices.
Improving Patient Safety
• The 510(k) report recommends that CDRH consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know about the safety and effectiveness of the device under review. This currently is not required; as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff to more efficiently make decisions and potentially avoid extensive follow-up inquiries.
• The 510(k) report recommends that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. The report also suggests the center create a regulation that would clarify the circumstances under which the center would rescind 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate and consider whether additional authority is needed.
• Both reports recommend that CDRH build upon public databases to include meaningful, up-to-date information that supports good decision making and promotes the safe use of devices. This could be accomplished by improving the current 510(k) database by including summaries of FDA review decisions, current labeling and photos. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on device regulations.
PearlDiver Creates Medical Information Website
Five numbers.
That is all it takes to unleash an avalanche of data about Warsaw Health System LLC-Kosciusko Community Hospital in Warsaw, Ind. Data such as the average Medicare charge ($17,655) and average Medicare reimbursement ($5,119) as well as the top 10 Medicare procedures performed there (total knee arthroscopy, partial hip replacement and hip resurfacing are among the more popular surgeries).
Such data are just a fraction of the free pieces of information that can be found on a new website, www.pearldiverinc.com. The site was launched by Fort Wayne, Ind.-based PearlDiver Technologies Inc., which provides data and analysis to medical device manufacturers and healthcare providers.
The data is based on 1.1 billion Health Insurance Portability and Accountability Act-compliant patient records and includes information on more than 6,000 healthcare providers. PearlDiver executives hope the site will act as a resource that helps patients, device manufacturers and healthcare providers cost-effectively resolve their medical problems.
“We really think that, in general in the United States, we are entering a new era of healthcare where information is going to be more important than in the past. Where payers are trying to push decision-making down to the patient level,” PearlDiver CEO Robin R. Young told Greater Fort Wayne Business Weekly. “Manufacturers are also being asked by regulators to justify the cost of their products within the context of patient outcomes. And hospitals need a lot of data to become more cost-effective without reducing care levels. It’s a delicate balance, and so hospitals are looking for more performance data, outcome data, that sort of thing.”
PearlDiver’s database is the nation’s largest, according to Young. Its size, he noted, allows the company to aggregate a wide variety of information in five areas on the site:
• Hospital Lookup provides visitors with key procedural, revenue and other data for more than 6,000 healthcare providers;
• Procedure Lookup provides information about medical procedures and diagnoses by specific medical codes;
• Data Guys Market Research provides detailed information on PearlDiver’s market reports, both standard and custom;
• Consumers Choice Health Savings Tool (not yet available) will enable users to compare the cost of any procedure performed at U.S. hospitals or clinics, which essentially will give prospective patients the opportunity to shop for services. The tool also will allow people to compare healthcare providers based on about 50 measurements of quality, including infection and mortality rates, wait times in hospital emergency rooms and patient ratings. As of press time, the tool was being readied for a September launch.
• Sales Territory (not yet available) will be an interface that gives salespeople calling on healthcare providers information to help them better understand a provider’s buying habits. This paid feature is expected to be available in January 2011.
Visitors to the website can access information contained in the database by entering the name of a hospital, a zip code, a procedure or a specific billing code.
PearlDiver currently is considering offering customized health savings tools to companies that would pay a small fee for the service. Other health savings data would remain free to the general public.
Formed in late 2006, PearlDiver provides data and analyses to medical device manufacturers. The company has offices in Colorado Springs, Colo., and Philadelphia, Pa.
Accutek Moving to Larger Facility
Accutek Testing Laboratory is tripling its space and adding 20 jobs as it expands into Fairfield, Ohio.
The materials testing firm in early August finalized the $1.5 million purchase of a 50,000-square-foot facility on Port Union Road. The company is using loans from the Ohio Department of Development and U.S. Small Business Administration to finance the project, according to a news release.
Renovation is underway for the company’s anticipated move at the end of September, when the lease ends on its facility in West Chester Township, Ohio. The new facility will enable the firm to meet growth targets for sales and hiring over the next five years, and gives employees more space in which to work.
“We’re jam packed in here like sardines,” President John McCloy told the Hamilton Journal-News of Hamilton, Ohio.
Unit Building Services of Cincinnati is performing such renovations as removing walls for more collaborative space and adapting warehouse space for a laboratory. The company is spending $300,000 on renovations and new equipment, McCloy said.
“Accutek’s focus is finding better ways to support our customers in their design and development projects,” McCloy said. “The purchase and renovation of this facility will position Accutek for expansion of in-house testing capacity with enhanced capabilities.”
McCloy bought Accutek in 2003. The company tests products manufactured for the aerospace, medical and manufacturing industries worldwide.
Accutek has less than 50 employees.
Orchid Expands Capabilities at Satellite Facility
Orchid Orthopedic Solutions LLC is adding cleaning and packaging capabilities to its coating facility in Michigan.
Company bigwigs said the expanded capabilities will enable the firm to “stay ahead of the curve” in validation. “We are excited to expand this capability and streamline the process for our customers,” said Matt Burba, Orchid’s executive vice president. “We are able to take a product from concept all the way through delivery, and this will add value to the manufacturing process.”
Executives appointed Wanda Colon-Rivera as packaging manager, but it is not clear whether her responsibilities are limited to the bio-coating facility in Southfield, Mich., or if she is in charge of packaging operations for the entire company. In her previous positions, Colon-Rivera managed several aspects of new product development, including product design validation and verification, clinical trials, packaging validations, process validations, and quality and regulatory requirements, including labeling.
Orchid’s Bio-Coat facility specializes in hydroxylapatite, titanium plasma spray and resorbable blast media surface treatments. The plant is registered with the U.S. Food and Drug Administration and has achieved ISO 13485:2003 certification.
Orchid Orthopedic Solutions designs and manufactures implants, instruments, and innovative technologies for the orthopedic, dental and cardiovascular markets. The company is based in Holt, Mich.
RevZero Expands its Manufacturing Capacity
Strong growth during the first half of 2010 has prompted RevZero Inc. to expand its multi-axis milling capabilities.
The 3-year-old precision machining and contract manufacturing firm has added a new vertical machining center, according to a news release. Executives did not provide details of the new machining center; they focused instead on the company’s 60 percent growth rate this year and its outlook for the remainder
of 2010.
“We expect strong growth and additional equipment purchases to continue for the rest of the year and into 2011,” said Eric Grenier, RevZero’s president.
Tom Weiss, the company’s vice president of sales, attributed the firm’s robust growth to its focus on customer service.
“We provide our customers the best in prototyping to full production capabilities for micro-precision metal and plastic components, sub-components and assemblies,” he said in the news release. “This growth is the result of our ability to provide customers with ultra-responsive services in all areas of our business, from answering the phones and providing quotes to final documentation and shipment.”
Based in Chanhassen, Minn. (a city located 16 miles southwest of Minneapolis), RevZero performs precision-machining services with the Swiss-type screw machines, conventional CNC (computed numerically controlled) machines and EDM wire technology.