Life @STARK, Hyderabad, India

Madhukiran Parvathaneni, PhD – Client Service Representative and Raghavendra Bikkumalla – Regulatory Specialist from Stark Associates, LLC, USA office VISIT to Hyderabad office.

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Stark Associates at BioAsia 2020, Hyderabad, India

Stark Associates is at BioAsia 2020, Hyderabad, India. Contact Dr.Madhukiran Parvathaneni for scheduling meeting at BioAsia2020 Conference.

Dr.Madhukiran Parvathaneni | 848-219-9146×101 |

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Join us at BioAsia 2020 – 17th to 19th, HICC, Hyderabad

Stark Associates, a leading provider of Contract Research (CRO) Services, is pleased to exhibit at the BioAsia 2020, 17th to 19th at Hyderabad International Convention Centre (HICC), HICC complex, Kondapur, Hyderabad, India.

Come meet Stark Associates Team at BioAsia 2020, Booth No. #45.

For meetings please contact:

Dr. Madhukiran Parvathaneni

Client Services Representative

Ph: +1 848-219-9146×101

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DCAT Week 2020

Stark Associates is a CRO firm providing various services like Clinical Operations, Regulatory Affairs, Pharmacovigilance, Medical Writing, Validation, Biostatistics and API & RLD Sourcing in US, Canada and India.

For Meetings, please contact:

Dr. Madhukiran Parvathaneni
Ph: +1 (848)-219-9146 Ext:101,

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US FDA proposes Single Electronic Submissions for Medical Devices

Questions? Request more information from Stark Associates.

Dr.Madhukiran Parvathaneni
Ph: +1 (848)-219-9146 Ext:101,

The US Food and Drug Administration has proposed to amend requirements for medical device premarket submissions to eliminate paper and multiple copies and replace them with requirements for a single submission in electronic format. The applicants currently require to submit both paper and electronic copies of 510(k) and other premarket submissions.

FDA has also clarified that the Agency would consider submissions copied to a CD, DVD, or flash drive and mailed to FDA, and eSubmissions, to be submissions in electronic format.

The FDA’s new proposed rule would apply to 510(k) premarket notifications, Investigational Device Exemptions (IDE), Premarket Approvals (PMA) applications and supplements, Humanitarian Device Exemptions (HDE) and Applications to the Center for Biologics Evaluation and Research (CBER).

If finalized, this action would reduce the number of copies in electronic format required, thus the FDA’s premarket submission program for medical devices is improved and made more efficient. These changes are intended to also improve the efficiency of the review process by allowing immediate availability of an electronic version for review, rather than relying solely on the paper version. Because a submission in electronic format is easily reproducible, the requirement for multiple copies (whether in electronic format or paper form) is no longer necessary. The amendment would produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions.

FDA proposes that any final rule based on this proposed rule become effective 30 days after the date of publication of a final rule in the Federal Register.

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Second Corrigendum by EU MDR grants grace period for some self-certified Class I medical devices

The European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR) pg 44 of 145 for English, with significant compliance deadline implications for some currently self-certified devices.

This change suggests that devices (not custom made devices) that are self-certified Class I under the current Medical Devices Directive 93/42/EEC (MDD) but that will be up-classified under the MDR will not have to be certified to the new Regulation from the Date of Application (May 26th, 2020). Instead, qualifying devices may rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices:

  • Class I reusable surgical devices;
  • Software, most of which would be up-classified to Class IIa or higher;
  • Many self-certified substance-based devices, of which some would be up-classified as far as Class III;
  • And many others.

Although most MDR requirements will apply, this delay in certification is not a delay in application of the MDR.

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US FDA issues detailed Framework for the Safety and Performance Based Pathway for abbreviated 510(k) medical device review

As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA has issued draft guidances identifying performance criteria and testing methodologies for certain devices within five class II device types. The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidances have been published. Once the FDA begins to operationalize this pathway, a medical device manufacturer will have the option to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device. The use of this pathway does not affect the FDA’s ability to request any information authorized by the statute or regulations.

This framework identifies five Class II device types for which the agency intends to establish performance criteria and testing methodology guidances ahead of launching the Safety and Performance Based Pathway:

  1. Spinal plating systems
  2. Cutaneous electrodes for recording purposes
  3. Conventional Foley catheters
  4. Orthopedic non-spinal metallic bone screws and washers
  5. Magnetic resonance coils

The Safety and Performance Based Pathway is appropriate when FDA has determined that:

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
  • The new device meets all the FDA-identified performance criteria.

If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).

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ANVISA: Reached milestone of 5000 international health product certifications using MDSAP in 2019

Brazilian medical device market regulator, ANVISA, according to a recent report showed a significant increase in medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP), with nearly half of all quality management system certifications issued in 2019 under MDSAP.

According to the report, the Medical Device Single Audit Program (MDSAP) reached, in 2019, the milestone of 5,000 participating companies. In addition, 48.7% of the total international health product certifications issued by ANVISA this year were made using the program. The number of device manufacturing sites in Brazil that participate in was 3,225 in 2017 and 778 in 2017.

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South Korean Ministry of Food and Drug Safety: Submission requirements for high-risk medical devices reduced

South Korean MFDS have reduced the registration submission requirements for Class-IV medical devices. This notice is expected to reduce submission preparation timeframes for Class IV device applicants, and potentially eases South Korean market entry.

As per the notice from MFDS, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical Documentation (STED) files along with Korean technical files when applying for South Korean market authorization. Instead, following STED-related documentation from Class IV device market applicants would be required:

  • Flow charts showing each step of the device’s manufacturing process;
  • Detailed explanations of processes that could affect the performance and/or effectiveness of the device;
  • Descriptions and indications of all sterilization methods, standards, validation cycles and conditions utilized in the device’s manufacturing process.
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Singapore Health Sciences Authority: new guidance on special authorization routes for unregistered medical devices

The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for the unregistered medical devices in the country.

These SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in case of emergencies, or when more conventional therapies have proven unsuccessful. The new guidance covers application processes, requirements and post-market obligations that must be met in order to import an unregistered device into Singapore via SAR. Devices that meet “special clinical needs,” intended for import/export, as well as those with non-clinical intended uses or purposes may be fall under HSA’s SAR program to obtain Singapore market entry.

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