[{"innerBlocks":[],"name":"core\/freeform","postId":1735,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Food and Drug Administration\u2019s quick approval of new mobile medical apps designed for the Apple Watch is raising eyebrows among FDA observers who say the tech behemoth got preferential treatment.

Last week, the FDA granted\u2014in two separate letters dated September 11\u2014two different \u201cde novo decisions\u201d in Apple\u2019s favor, according to Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues.

What\u2019s remarkable about the letters, says Thompson, is that Apple apparently filed its electrocardiogram (ECG) clearance application on August 14 and the Irregular Rhythm Notification Feature application on August 9.

Thompson points out that these requests are for first-of-a-kind devices and as a result typically take longer to approve than a follow-on device cleared through the 510(k) process.

\u201cFDA\u2019s goal with regard to reviewing de novo submissions is for FDA to \u2018issue a decision within 150 FDA days of receipt of the submission for\u202650 percent of de novo requests received in FY 2018,\u2019\u201d according to Thompson. \u201cTo be clear, that means it\u2019s expected that the other 50 percent will take longer than 150 days. FDA cleared not one but two Apple de novo reviews in fewer than 30 days. That\u2019s remarkable.\u201d

While Thompson acknowledges that the time for FDA review can be shortened by having significant discussions and data sharing with a vendor in advance of an actual filing, he contends that it is \u201cextremely rare to have a review that is less than 30 days.\u201d

In addition, Thompson is suspicious about the timing of the letters\u2014one day prior to Apple\u2019s September 12 launch event for the new products, which were announced in Cupertino, Calif., by Chief Operating Officer Jeff Williams.

\u201cProbably not coincidentally, on September 12, 2018\u2014the very same day that Apple had its big event\u2014FDA issued its own press release in support of what Apple was doing,\u201d adds Thompson. \u201cOthers have asked me whether this is typical for FDA to accelerate a clearance review and issue a decision so as to coincide with a company preselected launch date for a new product. I\u2019ve been doing this work for over 30 years, and I\u2019ve never heard of that.\u201d

Also See<\/b>: Apple gets FDA approval for new watch, touts health gains<\/a>

Thompson sent an email last week to the agency inquiring as to whether there is a \u201cnew policy of timing\u201d the FDA\u2019s approvals to \u201csupport pre-existing, company-selected new product launch dates.\u201d He has not yet received a response.

However, an FDA spokesperson did provide a written statement in response to a query from HDM.

\u201cWhile we cannot comment on specific interactions with a company, the FDA\u2019s premarket decision is made after the submitter has demonstrated reasonable assurance of the safety and effectiveness of a device,\u201d according to the statement. \u201cThat is independent from a company\u2019s decision to announce a product\u2019s marketing authorization or availability. We always encourage manufacturers\/developers to communicate and work with the FDA beginning very early in their development process and on a continuing basis using the presubmission process and other interactions. Depending on several factors, such as the level of risk associated with a product, a company\u2019s amount of experience in working with FDA, or how novel a product is, different applicants may interact with the FDA for varying amounts of time.\u201d

The regulatory agency also posted a statement<\/a> on September 12 from Scott Gottlieb, MD, commissioner of the FDA, and Jeff Shuren, MD, director of the FDA\u2019s Center for Devices and Radiological Health, discussing FDA efforts to work with technology vendors to spur innovation in digital health.

\u201cFirms may be new to healthcare products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas,\u201d stated Gottlieb and Shuren. \u201cA great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch\u2026The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly.\u201d

At the same time, Gottlieb and Shuren noted in their online statement that \u201chealthcare has been slow to implement disruptive technology tools\u201d and that the FDA\u2019s approach to \u201cregulating these novel, swiftly evolving products\u201d requires the agency to \u201ctake modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place.\u201d

Mike Kisch, co-founder and CEO of startup Beddr, whose SleepTuner is an FDA listed Class II medical device, sees the Apple announcement in a positive light generally.

\u201cI applaud the FDA for becoming more progressive and developing programs that allow them to think about products in a different way than they have in the past\u2014and, creating clearer pathways for digital health services and products to get to market,\u201d says Kisch. \u201cI think it\u2019s a fantastic watershed event not only for Apple, but other companies that are in the digital health space who are looking for stronger support from the FDA.\u201d

At the same time, Kisch is left scratching his head about the speed with which the FDA granted approval to Apple\u2019s ECG app for detecting the presence of atrial fibrillation.

\u201cIt\u2019s a little interesting to understand why that process moved so quickly\u2014with not that much information\u2014compared with other people in that space who have dedicated devices, specifically, to measure if a person is in AFib,\u201d adds Kisch. \u201cI think there\u2019s some proof to the complaints out there.\u201d

\u201cWhat I hope hasn\u2019t happened here is that there is a two-class system that has developed to stunt the opportunity for innovation amongst startups\u2014because we don\u2019t have the resources and the clout to push things through as fast as a big company,\u201d he concludes.

In September 2017, the agency selected nine technology vendors\u2014including Apple\u2014to participate in a pilot to help assess how pre-certified companies could bring certain types of consumer and patient apps to market without FDA premarket review or after a more streamlined premarket review process.

While the agency has been working on a new software pre-certification program for developers aimed at fast-tracking digital health products to market, Thompson contends that <\/b>as of yet the program remains \u201cvery broad and vague\u201d with the actual pilot planned for next year.

\u201cSo to my knowledge, the only thing that\u2019s happened between FDA and Apple are discussions regarding how to design the program,\u201d he adds. \u201cThat should not have had any impact on the clearances.\u201d

Regardless, Thompson says that the FDA \u201cneeds to comment publicly on what they\u2019ve done, to allow the entire industry to know what the rules are\u201d going forward. \u201cIt\u2019s important that the regulatory process be transparent, and if there are ways to accomplish what Apple accomplished in terms of timing going forward, everyone needs to know of those opportunities,\u201d he concludes.","saveContent":"The Food and Drug Administration\u2019s quick approval of new mobile medical apps designed for the Apple Watch is raising eyebrows among FDA observers who say the tech behemoth got preferential treatment.

Last week, the FDA granted\u2014in two separate letters dated September 11\u2014two different \u201cde novo decisions\u201d in Apple\u2019s favor, according to Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues.

What\u2019s remarkable about the letters, says Thompson, is that Apple apparently filed its electrocardiogram (ECG) clearance application on August 14 and the Irregular Rhythm Notification Feature application on August 9.

Thompson points out that these requests are for first-of-a-kind devices and as a result typically take longer to approve than a follow-on device cleared through the 510(k) process.

\u201cFDA\u2019s goal with regard to reviewing de novo submissions is for FDA to \u2018issue a decision within 150 FDA days of receipt of the submission for\u202650 percent of de novo requests received in FY 2018,\u2019\u201d according to Thompson. \u201cTo be clear, that means it\u2019s expected that the other 50 percent will take longer than 150 days. FDA cleared not one but two Apple de novo reviews in fewer than 30 days. That\u2019s remarkable.\u201d

While Thompson acknowledges that the time for FDA review can be shortened by having significant discussions and data sharing with a vendor in advance of an actual filing, he contends that it is \u201cextremely rare to have a review that is less than 30 days.\u201d

In addition, Thompson is suspicious about the timing of the letters\u2014one day prior to Apple\u2019s September 12 launch event for the new products, which were announced in Cupertino, Calif., by Chief Operating Officer Jeff Williams.

\u201cProbably not coincidentally, on September 12, 2018\u2014the very same day that Apple had its big event\u2014FDA issued its own press release in support of what Apple was doing,\u201d adds Thompson. \u201cOthers have asked me whether this is typical for FDA to accelerate a clearance review and issue a decision so as to coincide with a company preselected launch date for a new product. I\u2019ve been doing this work for over 30 years, and I\u2019ve never heard of that.\u201d

Also See<\/b>: Apple gets FDA approval for new watch, touts health gains<\/a>

Thompson sent an email last week to the agency inquiring as to whether there is a \u201cnew policy of timing\u201d the FDA\u2019s approvals to \u201csupport pre-existing, company-selected new product launch dates.\u201d He has not yet received a response.

However, an FDA spokesperson did provide a written statement in response to a query from HDM.

\u201cWhile we cannot comment on specific interactions with a company, the FDA\u2019s premarket decision is made after the submitter has demonstrated reasonable assurance of the safety and effectiveness of a device,\u201d according to the statement. \u201cThat is independent from a company\u2019s decision to announce a product\u2019s marketing authorization or availability. We always encourage manufacturers\/developers to communicate and work with the FDA beginning very early in their development process and on a continuing basis using the presubmission process and other interactions. Depending on several factors, such as the level of risk associated with a product, a company\u2019s amount of experience in working with FDA, or how novel a product is, different applicants may interact with the FDA for varying amounts of time.\u201d

The regulatory agency also posted a statement<\/a> on September 12 from Scott Gottlieb, MD, commissioner of the FDA, and Jeff Shuren, MD, director of the FDA\u2019s Center for Devices and Radiological Health, discussing FDA efforts to work with technology vendors to spur innovation in digital health.

\u201cFirms may be new to healthcare products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas,\u201d stated Gottlieb and Shuren. \u201cA great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch\u2026The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly.\u201d

At the same time, Gottlieb and Shuren noted in their online statement that \u201chealthcare has been slow to implement disruptive technology tools\u201d and that the FDA\u2019s approach to \u201cregulating these novel, swiftly evolving products\u201d requires the agency to \u201ctake modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place.\u201d

Mike Kisch, co-founder and CEO of startup Beddr, whose SleepTuner is an FDA listed Class II medical device, sees the Apple announcement in a positive light generally.

\u201cI applaud the FDA for becoming more progressive and developing programs that allow them to think about products in a different way than they have in the past\u2014and, creating clearer pathways for digital health services and products to get to market,\u201d says Kisch. \u201cI think it\u2019s a fantastic watershed event not only for Apple, but other companies that are in the digital health space who are looking for stronger support from the FDA.\u201d

At the same time, Kisch is left scratching his head about the speed with which the FDA granted approval to Apple\u2019s ECG app for detecting the presence of atrial fibrillation.

\u201cIt\u2019s a little interesting to understand why that process moved so quickly\u2014with not that much information\u2014compared with other people in that space who have dedicated devices, specifically, to measure if a person is in AFib,\u201d adds Kisch. \u201cI think there\u2019s some proof to the complaints out there.\u201d

\u201cWhat I hope hasn\u2019t happened here is that there is a two-class system that has developed to stunt the opportunity for innovation amongst startups\u2014because we don\u2019t have the resources and the clout to push things through as fast as a big company,\u201d he concludes.

In September 2017, the agency selected nine technology vendors\u2014including Apple\u2014to participate in a pilot to help assess how pre-certified companies could bring certain types of consumer and patient apps to market without FDA premarket review or after a more streamlined premarket review process.

While the agency has been working on a new software pre-certification program for developers aimed at fast-tracking digital health products to market, Thompson contends that <\/b>as of yet the program remains \u201cvery broad and vague\u201d with the actual pilot planned for next year.

\u201cSo to my knowledge, the only thing that\u2019s happened between FDA and Apple are discussions regarding how to design the program,\u201d he adds. \u201cThat should not have had any impact on the clearances.\u201d

Regardless, Thompson says that the FDA \u201cneeds to comment publicly on what they\u2019ve done, to allow the entire industry to know what the rules are\u201d going forward. \u201cIt\u2019s important that the regulatory process be transparent, and if there are ways to accomplish what Apple accomplished in terms of timing going forward, everyone needs to know of those opportunities,\u201d he concludes.","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

FDA comes under fire for rapid Apple Watch approvals

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