FDA To Outline mHealth Guidelines In 2013
Mobile health apps are gaining momentum and saturating the healthcare market, so it's no wonder the FDA is looking to set guidelines in place to regulate this booming sector. Many consumers are beginning to trust these applications as much as they would a physician, and many healthcare professionals are utilising mobile tools for information and file sharing.
The FDA testified before the House Energy and Commerce Committee this week, where it was asked how it plans to ensure mHealth apps are useful, standardized and accurate. The Committee also questioned how the FDA would regulate apps utilised by physicians and those, which integrated into electronic health records.
The FDA issued a draft in 2011, however it is yet to finalize its rulemaking. Furthermore, the firm is still making decisions about the tax status of mobile devices and health apps. The Committee cited tax as one of its major concerns; under the Affordable Care Act, regulated medical devices are subject to a 2.3 percent excise tax. If the FDA determines that mHealth apps, tablets and smartphones fall under that category, they could be forced to pay the additional amount, which is enough that some industry experts believe it could stifle mHealth innovation and development.
“Revenues [from mHealth development] are ploughed back into the company for growth, therefore the 2.3 percent tax on startup companies increases the amount that must be invested before companies become cash-flow positive,” said Dr T Forcht Dagi, Partner at HLM Venture Partners.
App developers have been eagerly awaiting a set of guidelines from the FDA regarding mHealth regulation
However, Christy Foreman, Director of the Office of Device Evaluation at the FDA, said there was little cause for alarm. The agency will not label all smartphones or tablets that could possibly run a medical app as medical devices, nor does the FDA have any wish to limit innovation by imposing undue burdens.
“FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections,” she said.
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The FDA emphasised that calorie counters and fitness trackers posed little threat to patients, however apps that carried the same risk to patients as hospital-grade medical devices, such as those used to operate CT scanners from an iPad or program infusion pumps, should be regulated just as much as the equipment they link to.
“[The FDA has been] regulating medical device software for decades and medical device software on mobile platforms for more than ten years,” Foreman told the Committee. She continued, saying that adding certain mHealth apps to that catalogue of responsibilities would bring little detrimental change to the industry.
It’s the two-year delay in rulemaking that’s causing problems, argue many developers who have been waiting since July 21, 2011 to hear the fate of their business. Ben Chodor, CEO of Happtique, testified that some developers are stalling on potential products due to the uncertainty surrounding the FDA’s plans. Committee members speculated that taxes on medical apps might push programmers away from the next greatest health innovation and towards a more lucrative area, such as smartphone games or office software.
Foreman assured the committee that final guidance would be issued by the end of fiscal year 2013, bringing an end to the long wait, if not total satisfaction to those frustrated by government involvement in the first place. “We believe that focusing oversight on a narrow subset of mobile apps will encourage the development of new products while providing appropriate patient protections,” she concluded.
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.